<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01681628</url>
  </required_header>
  <id_info>
    <org_study_id>Uganda2012</org_study_id>
    <nct_id>NCT01681628</nct_id>
  </id_info>
  <brief_title>Community Self-help Using Thought Field Therapy in a Traumatised Population in Uganda: a Randomised Trial</brief_title>
  <official_title>Effectiveness of Thought Field Therapy Provided by Newly Instructed Community Workers to a Traumatized Population in Uganda: A Randomised Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thought Field Therapy Foundation (UK) Ltd</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Thought Field Therapy Foundation.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mats Uldal Humanitarian Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Thought Field Therapy Foundation (UK) Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Thought Field Therapy (TFT) is a simple technique that involves tapping on points of the body&#xD;
      corresponding to the meridians used in acupuncture. By using specific sequences, TFT can be&#xD;
      used to treat a variety of psychological problems. Patients can be taught to treat&#xD;
      themselves, and lay people can be trained to treat others in their community, as has been&#xD;
      shown for narrative exposure therapy.&#xD;
&#xD;
      Thought Field Therapy has been used to treat whole communities who have suffered&#xD;
      psychological trauma following natural disasters and violent conflicts. In these&#xD;
      circumstances, TFT can be used as a stand-alone therapy, or as an adjunct to other&#xD;
      psychological therapies, by removing the pain of re-living the traumatic events.&#xD;
&#xD;
      Studies in Rwanda have shown that individuals within a community can be treated with brief&#xD;
      TFT sessions. Both short-term and longer-term improvements in scores of Post-Traumatic Stress&#xD;
      Disorder (PTSD) measurement scales have been demonstrated.&#xD;
&#xD;
      The Kasese District in Uganda has suffered from factional conflicts and the consequences of&#xD;
      the ongoing struggles in neighbouring countries for many years. Although the government has&#xD;
      controlled the situation and secured the borders, many are still haunted by the psychological&#xD;
      consequences.&#xD;
&#xD;
      The purpose of the study is to validate the model of addressing widespread psychological&#xD;
      trauma following conflict by training community leaders to help others in their community&#xD;
      using TFT.&#xD;
&#xD;
      Thirty-six community leaders will be given a two-day training in algorithm level&#xD;
      trauma-relief TFT. They will then treat 128 volunteers for their traumas, using TFT, who will&#xD;
      be assessed before and one week after treatment by the post-traumatic stress disorder&#xD;
      check-list questionnaire for civilians (PCL-C). As a control, a further 128 volunteers will&#xD;
      join a wait-list group, who will be assessed at the same time, but treated later.&#xD;
&#xD;
      PCL-C scores before and after treatment will be compared with the wait-list group scores&#xD;
      before and after waiting, but before their treatment.&#xD;
&#xD;
      A follow-up assessment of the participants will be undertaken 1 to 2 years later.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Six TFT practitioners from the USA, Great Britain, and Norway will train 36 community leaders&#xD;
      during a two-day trauma-relief training programme. These newly-trained practitioners will&#xD;
      then treat 256 volunteers who feel that they are suffering from psychological trauma. The six&#xD;
      visiting practitioners, together with two additional TFT practitioners from Rwanda, will&#xD;
      supervise and support the study following the training.&#xD;
&#xD;
      A Catholic Priest, Father Peter Mubunga Basaliza, on behalf of the Kasese Diocese, will&#xD;
      organise the recruitment of the local trainers and volunteer participants, including&#xD;
      publicising by local radio. All faiths will be welcome, but volunteers must be 18 years of&#xD;
      age or older. Volunteers will be informed of their allocated date and time to attend for&#xD;
      inclusion in the study. Any volunteer who cannot be accommodated in the study because the&#xD;
      pre-requisite number has been met, will be offered TFT by the visiting practitioners and&#xD;
      trained community leaders.&#xD;
&#xD;
      Signed consent will be obtained prior to commencing the study. Participants will be provided&#xD;
      with an information sheet and duplicate consent forms in Lhukonzo (the local language), and&#xD;
      assistance will be provided by Ugandan therapists for those who have difficulty reading.&#xD;
      Consent forms will also be available in English for those for whom it is the preferred&#xD;
      language. Each participant will also complete a demographic questionnaire.&#xD;
&#xD;
      Participants will be free to withdraw at any time, and any who do so will still be offered&#xD;
      TFT, if desired.&#xD;
&#xD;
      Sixty-four participants will be seen each day, 32 in the morning, and 32 in the afternoon,&#xD;
      for four consecutive days. They will be allocated according to a previously computer&#xD;
      generated random number sequence, to Group A and provided with a blue folder, or Group B and&#xD;
      provided with a red folder. Their names will be recorded on a sign-in sheet. They will be&#xD;
      identified by a number, which will be written on their folder and documents. Both groups will&#xD;
      initially complete the post-trauma checklist (PCL-C) questionnaire (www.pdhealth.mil)&#xD;
      available in Lhukonzo, referring to symptoms within the previous week. Therapists, who will&#xD;
      be unaware of the individual's group allocation, will assist if necessary. The PCL-C has been&#xD;
      translated from English into Lhukonzo and back into English to ensure that the translation is&#xD;
      accurate.&#xD;
&#xD;
      The PCL-C consists of 17 questions, each question scoring from 1 - 5. Thus the minimum score&#xD;
      is 17 and maximum score 85. A score of 17 has no features of PTSD and 85 the highest score&#xD;
      for PTSD. When used as a screening tool, a score of more than 50 is considered to be&#xD;
      diagnostic of PTSD.&#xD;
&#xD;
      Completed questionnaires and consent forms will be kept in their folders and retained by the&#xD;
      researchers.&#xD;
&#xD;
      Following completion of their PCL-C forms, Group A participants will be treated using Thought&#xD;
      Field Therapy by the newly trained therapists for their traumas, supervised by the&#xD;
      researchers. The therapists will keep a record for each participant of the problem that was&#xD;
      treated, algorithms used, the time taken, and the Subjective Units of Distress (SUD) scores&#xD;
      (0-10).&#xD;
&#xD;
      Group B will be a control (wait-list group) and will receive no treatment following their&#xD;
      first visit. This model has been successfully utilised in Rwanda.&#xD;
&#xD;
      One week later, at the same time and day of the week as they first attended, the participants&#xD;
      in group A and group B will return and repeat their PCL. On this occasion, testing will be&#xD;
      followed by treatment for Group B.&#xD;
&#xD;
      After a further week, Group B only will return for repeat testing using PCL.&#xD;
&#xD;
      In summary, the protocol to be followed will be:&#xD;
&#xD;
        -  Two-day training of new therapists&#xD;
&#xD;
        -  Day one of study: 9am - PCL test of 16 Group A and 16 Group B 11am -Treat the 16 Group A&#xD;
&#xD;
           1pm - Test a new group of 16 A and 16 B 3pm - Treat the new 16 group A&#xD;
&#xD;
        -  Days 2-4: Same as for day one, but with new participants. Each therapist will treat the&#xD;
           same number in each group.&#xD;
&#xD;
        -  Days 8-11 9am -PCL test of 16 Group A and 16 Group B 11am -Treat the 16 Group B&#xD;
&#xD;
           1pm - Test another 16 of each Group 3pm -Treat the new Group B&#xD;
&#xD;
        -  Day 18 Test all Group B, 16 every two hours from 9am&#xD;
&#xD;
      Mean + SD PCL test scores will be calculated for each group during their four days of each&#xD;
      week, and of Group B on day 18. That is:&#xD;
&#xD;
      Group A days 1-4 (A pre-treatment) Group B days 1-4 (B pre-treatment) Group A days 8-11 (A&#xD;
      post-treatment) Group B days 8-11 (B post-no treatment) Group B day 18 (B post-treatment)&#xD;
&#xD;
      The statistical significance of differences of mean scores will be analysed by analysis of&#xD;
      variance and paired samples t tests. Significances of differences in group proportions with&#xD;
      diagnostic scores for PTSD will be assessed by a non-parametric test.&#xD;
&#xD;
      Statistically significant differences were found in a similar study in Rwanda, with smaller&#xD;
      numbers, so the study will be adequately powered.&#xD;
&#xD;
      A follow-up assessment will be done 19 months later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">July 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Post-traumatic Stress Disorder Check List for Civilians (PLC-C) Score.</measure>
    <time_frame>Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)</time_frame>
    <description>PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. The wait list group received no treatment at Time 1.&#xD;
In the treatment arm, measure immediately pre-treatment (baseline) (time 1) and one week later (time 2).&#xD;
In the wait-list no therapy arm, measure at baseline (time 1), and after one week (no treatment) (time 2). The wait-list group (Thought Field Therapy group) were then treated and reassessed after a further week (time 3).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C &gt; 50) Before and After Treatment in Treatment and Control Groups.</measure>
    <time_frame>Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)</time_frame>
    <description>PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. The wait list group received no treatment at Time 1.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">256</enrollment>
  <condition>Post-traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Thought Field Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thought Field Therapy delivered by trained community leaders.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait list</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Delayed intervention.&#xD;
No intervention prior to assessment after one week (pre-test 2). Then treated with Thought Field Therapy, and re-assessed after a further week (post-test).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Thought Field Therapy.</intervention_name>
    <description>Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.</description>
    <arm_group_label>Thought Field Therapy</arm_group_label>
    <arm_group_label>Wait list</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteers recruited from local communities, who feel that they are suffering from&#xD;
             psychological trauma.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minimum age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert H Robson, MA MB BChir</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thought Field Therapy Foundation (UK) Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Augustine's Catechist Training Centre, PO Box 155</name>
      <address>
        <city>Kasese</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <link>
    <url>http://en.wikipedia.org/wiki/Rwenzururu</url>
    <description>Background to local conflicts potentially causing post-traumatic stress disorder.</description>
  </link>
  <link>
    <url>http://www.tftfoundation.org</url>
    <description>Co-sponsor</description>
  </link>
  <link>
    <url>http://matsuldalhumanitarianfondation.wordpress.com/</url>
    <description>Co-sponsor</description>
  </link>
  <reference>
    <citation>Callahan RJ. Tapping the healer within. New York, NY: McGraw-Hill, 2001</citation>
  </reference>
  <reference>
    <citation>Connolly S, Sakai C. Brief trauma intervention with Rwandan genocide-survivors using thought field therapy. Int J Emerg Ment Health. 2011;13(3):161-72.</citation>
    <PMID>22708146</PMID>
  </reference>
  <reference>
    <citation>Ertl V, Pfeiffer A, Schauer E, Elbert T, Neuner F. Community-implemented trauma therapy for former child soldiers in Northern Uganda: a randomized controlled trial. JAMA. 2011 Aug 3;306(5):503-12. doi: 10.1001/jama.2011.1060.</citation>
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    <citation>Feinstein D. Energy psychology in disaster relief. Traumatology 14: 127-129, 2008.</citation>
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    <citation>Connolly SM, Roe-Sepowitz D, Sakai C, Edwards J. Utilizing community resources to treat PTSD: randomised controlled study using thought field therapy. African Journal of Traumatic Stress 3: 82-90, 2013.</citation>
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    <citation>Feinstein D. Rapid treatment of PTSD: why psychological exposure with acupoint tapping may be effective. Psychotherapy (Chic). 2010 Sep;47(3):385-402. doi: 10.1037/a0021171.</citation>
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    <citation>Folkes CE. Thought field therapy and trauma recovery. Int J Emerg Ment Health. 2002 Spring;4(2):99-103.</citation>
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    <citation>Galea S, Nandi A, Vlahov D. The epidemiology of post-traumatic stress disorder after disasters. Epidemiol Rev. 2005;27:78-91. doi: 10.1093/epirev/mxi003. No abstract available.</citation>
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    <citation>Hui KK, Liu J, Makris N, Gollub RL, Chen AJ, Moore CI, Kennedy DN, Rosen BR, Kwong KK. Acupuncture modulates the limbic system and subcortical gray structures of the human brain: evidence from fMRI studies in normal subjects. Hum Brain Mapp. 2000;9(1):13-25. doi: 10.1002/(sici)1097-0193(2000)9:13.0.co;2-f.</citation>
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    <citation>Jonas DE, Cusack K, Forneris CA, Wilkins TM, Sonis J, Middleton JC, Feltner C, Meredith D, Cavanaugh J, Brownley KA, Olmsted KR, Greenblatt A, Weil A, Gaynes BN. Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder (PTSD) [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Apr. Report No.: 13-EHC011-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK137702/</citation>
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    <citation>Metcalf O, Varker T, Forbes D, Phelps A, Dell L, DiBattista A, Ralph N, O'Donnell M. Efficacy of Fifteen Emerging Interventions for the Treatment of Posttraumatic Stress Disorder: A Systematic Review. J Trauma Stress. 2016 Feb;29(1):88-92. doi: 10.1002/jts.22070. Epub 2016 Jan 7.</citation>
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    <citation>Reed RV, Fazel M, Goldring L. Post-traumatic stress disorder. BMJ. 2012 Jun 25;344:e3790. doi: 10.1136/bmj.e3790. No abstract available.</citation>
    <PMID>22734075</PMID>
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  <reference>
    <citation>Stone B, Leyden L, Fellows B. Energy Psychology treatment for post traumatic stress in genocide survivors in a Rwandan orphanage: a pilot investigation. Energy Psychology 1: 73-81, 2009.</citation>
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    <citation>Stone B, Leyden L, Fellows B. Energy Psychology treatment for orphan heads of households in Rwanda. Energy Psychology 2: 31-38, 2010.</citation>
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    <citation>Watts BV, Schnurr PP, Mayo L, Young-Xu Y, Weeks WB, Friedman MJ. Meta-analysis of the efficacy of treatments for posttraumatic stress disorder. J Clin Psychiatry. 2013 Jun;74(6):e541-50. doi: 10.4088/JCP.12r08225.</citation>
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    <citation>Dunnewold AL. Thought Field Therapy efficacy following large scale traumatic events. Current Research in Psychology 5: 34-39, 2014. DOI: 10.3844/crpsp.2014.34.39</citation>
  </results_reference>
  <results_reference>
    <citation>Robson RH, Robson PM, Ludwig R, Mitabu C, Phillips C. Effectiveness of Thought Field Therapy Provided by Newly Instructed Community Workers to a Traumatized Population in Uganda: A Randomized Trial. Current Research in Psychology http://thescipub.com/PDF/ofsp.10454.pdf, 2016.</citation>
  </results_reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 2, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <results_first_submitted>May 1, 2016</results_first_submitted>
  <results_first_submitted_qc>March 18, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 1, 2017</results_first_posted>
  <last_update_submitted>March 18, 2017</last_update_submitted>
  <last_update_submitted_qc>March 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Thought Field Therapy Foundation (UK) Ltd</investigator_affiliation>
    <investigator_full_name>Robert Howard Robson</investigator_full_name>
    <investigator_title>Dr Robert Howard Robson</investigator_title>
  </responsible_party>
  <keyword>Thought Field Therapy.</keyword>
  <keyword>Post-traumatic stress disorder.</keyword>
  <keyword>Post-traumatic stress disorder check list for Civilians.</keyword>
  <keyword>Uganda</keyword>
  <keyword>Ugandan therapists.</keyword>
  <keyword>Community treatment.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Spreadsheet available on request. Individual paper copies also available.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Public announcement throughout Kasese district of Uganda for those with symptoms of PTSD (described in announcement).</recruitment_details>
      <pre_assignment_details>Participants had been previously identified. As an excess number presented, only sufficient for the trial were assigned. One participant was excluded as not meeting age criteria (had to be 18 years old or over).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Thought Field Therapy</title>
          <description>Thought Field Therapy delivered by trained community leaders.&#xD;
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.</description>
        </group>
        <group group_id="P2">
          <title>Wait List</title>
          <description>Delayed intervention.&#xD;
No intervention prior to assessment after one week (pre-test 2). Then treated with Thought Field Therapy, and re-assessed after a further week (post-test).&#xD;
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Time 1 (Entry) to Time 2 One Week Later.</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="128"/>
                <participants group_id="P2" count="128"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="114"/>
                <participants group_id="P2" count="122"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Time 2 to Time 3 (One Week Later).</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">Only wait list group studied in this period.</participants>
                <participants group_id="P2" count="122"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0">Only wait list group studied in this period.</participants>
                <participants group_id="P2" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>19 Months Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="114"/>
                <participants group_id="P2" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Local population from Kasese district in Uganda who admitted to symptoms suggestive of PTSD and volunteered to participate. Non-attenders at Time 2 were not included in the analysis.</population>
      <group_list>
        <group group_id="B1">
          <title>Thought Field Therapy (TFT)</title>
          <description>Thought Field Therapy delivered by trained community leaders.&#xD;
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.&#xD;
Both groups were invited to attend 19 months later</description>
        </group>
        <group group_id="B2">
          <title>Wait List</title>
          <description>Delayed intervention.&#xD;
No intervention prior to assessment after one week (pre-test 2). Then treated with Thought Field Therapy, and re-assessed after a further week (post-test).&#xD;
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.&#xD;
Both groups were invited to attend 19 mo the later.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="114"/>
            <count group_id="B2" value="122"/>
            <count group_id="B3" value="236"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.3" spread="16"/>
                    <measurement group_id="B2" value="45.1" spread="14.4"/>
                    <measurement group_id="B3" value="44.5" spread="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="202"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>African (Western Uganda)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                    <measurement group_id="B2" value="122"/>
                    <measurement group_id="B3" value="236"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PCL-C</title>
          <description>PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. The wait list group received no treatment at Time 1.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.0" spread="12.6"/>
                    <measurement group_id="B2" value="61.2" spread="10.1"/>
                    <measurement group_id="B3" value="59.6" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Post-traumatic Stress Disorder Check List for Civilians (PLC-C) Score.</title>
        <description>PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. The wait list group received no treatment at Time 1.&#xD;
In the treatment arm, measure immediately pre-treatment (baseline) (time 1) and one week later (time 2).&#xD;
In the wait-list no therapy arm, measure at baseline (time 1), and after one week (no treatment) (time 2). The wait-list group (Thought Field Therapy group) were then treated and reassessed after a further week (time 3).</description>
        <time_frame>Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)</time_frame>
        <population>Participants with symptoms suggestive of PTSD, excluding non-attenders at Time 2. Non-attenders at time 3 were excluded from the wait-list (Thought Field Therapy) arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Thought Field Therapy</title>
            <description>Thought Field Therapy delivered by trained community leaders.&#xD;
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.</description>
          </group>
          <group group_id="O2">
            <title>Wait List: no Therapy</title>
            <description>No thought field therapy intervention prior to assessment after one week (pre-test 2).&#xD;
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.</description>
          </group>
          <group group_id="O3">
            <title>Wait-list: Thought Field Therapy</title>
            <description>Received thought field therapy after second assessment (time 2) and re-assessed one week later (time 3).&#xD;
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Post-traumatic Stress Disorder Check List for Civilians (PLC-C) Score.</title>
          <description>PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. The wait list group received no treatment at Time 1.&#xD;
In the treatment arm, measure immediately pre-treatment (baseline) (time 1) and one week later (time 2).&#xD;
In the wait-list no therapy arm, measure at baseline (time 1), and after one week (no treatment) (time 2). The wait-list group (Thought Field Therapy group) were then treated and reassessed after a further week (time 3).</description>
          <population>Participants with symptoms suggestive of PTSD, excluding non-attenders at Time 2. Non-attenders at time 3 were excluded from the wait-list (Thought Field Therapy) arm.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="122"/>
                <count group_id="O3" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.4" spread="14.7"/>
                    <measurement group_id="O2" value="12.4" spread="14.2"/>
                    <measurement group_id="O3" value="20.6" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Means and differences were calculated for both groups before (time 1) and after treatment (or no treatment) (time 2). Also, the differences in mean scores from time 1 to 2 were compared between the two groups, the primary outcome. The numbers in the groups were considered adequate based on previous similar studies. The null hypothesis was that there would be no difference in any mean change in scores from time 1 to 2, between both groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>This was an a priori threshold.</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>20.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.0</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>16.1</ci_lower_limit>
            <ci_upper_limit>24.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Change in PCL-C scores from before to after treatment.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>32.4</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>14.7</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>29.1</ci_lower_limit>
            <ci_upper_limit>34.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Changes in PCL-C scores for control group after no treatment.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>12.4</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>14.2</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.4</ci_lower_limit>
            <ci_upper_limit>17.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change in control group PCL-C scores after treatment, that is from time 2 to time 3.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>Degrees of freedom 94</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>20.6</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>13.5</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>17.1</ci_lower_limit>
            <ci_upper_limit>22.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C &gt; 50) Before and After Treatment in Treatment and Control Groups.</title>
        <description>PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. The wait list group received no treatment at Time 1.</description>
        <time_frame>Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)</time_frame>
        <population>Participants with symptoms suggestive of PTSD, thought field therapy group treated, wait list group not treated, and wait-list group treated. All assessed one week after initial assessment and treatment, and the percentage with a score &gt; 50 compared before and after treatment, or control.</population>
        <group_list>
          <group group_id="O1">
            <title>Thought Field Therapy</title>
            <description>Thought Field Therapy delivered by trained community leaders.&#xD;
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.</description>
          </group>
          <group group_id="O2">
            <title>Wait List no Treatment</title>
            <description>No intervention prior to assessment after one week (pre-test 2).&#xD;
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.</description>
          </group>
          <group group_id="O3">
            <title>Wait List: Thought Field Therapy</title>
            <description>After two control assessments at times 1 and 2, the wait list group were treated and re-assessed one week later at time 3. Non-attenders at time 3 were excluded from analysis.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C &gt; 50) Before and After Treatment in Treatment and Control Groups.</title>
          <description>PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. The wait list group received no treatment at Time 1.</description>
          <population>Participants with symptoms suggestive of PTSD, thought field therapy group treated, wait list group not treated, and wait-list group treated. All assessed one week after initial assessment and treatment, and the percentage with a score &gt; 50 compared before and after treatment, or control.</population>
          <units>percentage with PCL-C score &gt; 50</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="122"/>
                <count group_id="O3" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                    <count group_id="O2" value="122"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.5"/>
                    <measurement group_id="O2" value="82.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                    <count group_id="O2" value="122"/>
                    <count group_id="O3" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8"/>
                    <measurement group_id="O2" value="41.8"/>
                    <measurement group_id="O3" value="41.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Chi-squared test of any change in PCL-C from time 1 to time 2.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Chi-squared</method>
            <param_type>percentage of participants</param_type>
            <param_value>65.7</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of the percentage with diagnostic scores in the wait list group after no treatment at times 1 and 2.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Chi-squared</method>
            <param_type>% of participants with PCL score &gt; 50</param_type>
            <param_value>41.0</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Chi-squared</method>
            <param_type>Percentage</param_type>
            <param_value>39.9</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Assessment of Any Persisting Benefit of TFT (Thought Field Therapy) After 19 Months.</title>
        <description>PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C one week following treatment and nineteen months later. Comparison of PCL-C scores at nineteen months compared to one week following treatment.</description>
        <time_frame>1 week post-treatment (Time 2, TFT; Time 3, WL) and 19 months later.</time_frame>
        <population>All those who had scores one week after treatment and at 19 months. Similar gender and age proportions to original groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Thought Field Therapy</title>
            <description>Thought Field Therapy delivered by trained community leaders.&#xD;
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Any Persisting Benefit of TFT (Thought Field Therapy) After 19 Months.</title>
          <description>PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C one week following treatment and nineteen months later. Comparison of PCL-C scores at nineteen months compared to one week following treatment.</description>
          <population>All those who had scores one week after treatment and at 19 months. Similar gender and age proportions to original groups.</population>
          <units>units on a scale (PCL-C score)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>one week following treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.8" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>19 months later</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.6" spread="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Both the original treatment and control groups were combined as both groups had been treated at a similar time before the nineteen month assessment. The null hypothesis was that there had been no change in the PCL-C scores at nineteen months compared to one week following treatment.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>17.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>15.2</ci_lower_limit>
            <ci_upper_limit>20.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Assessment of Continuing Benefit of TFT After 19 Months, in Control Group, as Measured by a Diagnosis of PTSD According to a PCL-C Score of &gt;50.</title>
        <description>PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. Only the wait-list control group was used as the treatment group did not not have a run-in score, and would have given inappropriately positive results.</description>
        <time_frame>Time 2 and 19 months later.</time_frame>
        <population>83% female average age 43 years, 17% male average age 46.7 years.</population>
        <group_list>
          <group group_id="O1">
            <title>Wait List Group</title>
            <description>Those in the wait list, who had attended for their second immediate pre-treatment assessment and attended for assessment 19 months later.</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Continuing Benefit of TFT After 19 Months, in Control Group, as Measured by a Diagnosis of PTSD According to a PCL-C Score of &gt;50.</title>
          <description>PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. Only the wait-list control group was used as the treatment group did not not have a run-in score, and would have given inappropriately positive results.</description>
          <population>83% female average age 43 years, 17% male average age 46.7 years.</population>
          <units>percentage of PCL-C scores &gt;50.</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PCL-C score pre-treatment (time 2) &gt;50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% with PCL-C score &gt;50 at 19 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Complete up to time 3, that is one week after treatment. Incomplete up to 19 months later.</time_frame>
      <desc>Adverse events were reported for all those who were treated. There were 128 in the treatment group, but only 122 in the waitlist group as four did not attend for treatment at time 2, making 250 in total.</desc>
      <group_list>
        <group group_id="E1">
          <title>Thought Field Therapy</title>
          <description>Thought Field Therapy delivered by trained community leaders.&#xD;
Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.&#xD;
Both groups were invited to attend 19 months later</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <description>Cause unknown</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Functional seizure</sub_title>
                <description>Known history of blackouts, likely to be non-organic. One occurred during therapy with complete recovery.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Hysterical reaction</sub_title>
                <description>Uncontrollable shaking and rapid speech</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Only one assessment tool for PTSD was used. The 19 month data interpretation was limited by the high drop-out rate.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr R H Robson</name_or_title>
      <organization>Thought field Therapy Foundation UK Ltd.</organization>
      <phone>+44 (0)1952550688</phone>
      <email>r.robson2@btinternet.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01681628
org study id: Uganda2012
nct id: NCT01681628
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Thought Field Therapy (TFT) is a simple technique that involves tapping on points of the body
      corresponding to the meridians used in acupuncture. By using specific sequences, TFT can be
      used to treat a variety of psychological problems. Patients can be taught to treat
      themselves, and lay people can be trained to treat others in their community, as has been
      shown for narrative exposure therapy.

      Thought Field Therapy has been used to treat whole communities who have suffered
      psychological trauma following natural disasters and violent conflicts. In these
      circumstances, TFT can be used as a stand-alone therapy, or as an adjunct to other
      psychological therapies, by removing the pain of re-living the traumatic events.

      Studies in Rwanda have shown that individuals within a community can be treated with brief
      TFT sessions. Both short-term and longer-term improvements in scores of Post-Traumatic Stress
      Disorder (PTSD) measurement scales have been demonstrated.

      The Kasese District in Uganda has suffered from factional conflicts and the consequences of
      the ongoing struggles in neighbouring countries for many years. Although the government has
      controlled the situation and secured the borders, many are still haunted by the psychological
      consequences.

      The purpose of the study is to validate the model of addressing widespread psychological
      trauma following conflict by training community leaders to help others in their community
      using TFT.

      Thirty-six community leaders will be given a two-day training in algorithm level
      trauma-relief TFT. They will then treat 128 volunteers for their traumas, using TFT, who will
      be assessed before and one week after treatment by the post-traumatic stress disorder
      check-list questionnaire for civilians (PCL-C). As a control, a further 128 volunteers will
      join a wait-list group, who will be assessed at the same time, but treated later.

      PCL-C scores before and after treatment will be compared with the wait-list group scores
      before and after waiting, but before their treatment.

      A follow-up assessment of the participants will be undertaken 1 to 2 years later.
Six TFT practitioners from the USA, Great Britain, and Norway will train 36 community leaders
      during a two-day trauma-relief training programme. These newly-trained practitioners will
      then treat 256 volunteers who feel that they are suffering from psychological trauma. The six
      visiting practitioners, together with two additional TFT practitioners from Rwanda, will
      supervise and support the study following the training.

      A Catholic Priest, Father Peter Mubunga Basaliza, on behalf of the Kasese Diocese, will
      organise the recruitment of the local trainers and volunteer participants, including
      publicising by local radio. All faiths will be welcome, but volunteers must be 18 years of
      age or older. Volunteers will be informed of their allocated date and time to attend for
      inclusion in the study. Any volunteer who cannot be accommodated in the study because the
      pre-requisite number has been met, will be offered TFT by the visiting practitioners and
      trained community leaders.

      Signed consent will be obtained prior to commencing the study. Participants will be provided
      with an information sheet and duplicate consent forms in Lhukonzo (the local language), and
      assistance will be provided by Ugandan therapists for those who have difficulty reading.
      Consent forms will also be available in English for those for whom it is the preferred
      language. Each participant will also complete a demographic questionnaire.

      Participants will be free to withdraw at any time, and any who do so will still be offered
      TFT, if desired.

      Sixty-four participants will be seen each day, 32 in the morning, and 32 in the afternoon,
      for four consecutive days. They will be allocated according to a previously computer
      generated random number sequence, to Group A and provided with a blue folder, or Group B and
      provided with a red folder. Their names will be recorded on a sign-in sheet. They will be
      identified by a number, which will be written on their folder and documents. Both groups will
      initially complete the post-trauma checklist (PCL-C) questionnaire (www.pdhealth.mil)
      available in Lhukonzo, referring to symptoms within the previous week. Therapists, who will
      be unaware of the individual's group allocation, will assist if necessary. The PCL-C has been
      translated from English into Lhukonzo and back into English to ensure that the translation is
      accurate.

      The PCL-C consists of 17 questions, each question scoring from 1 - 5. Thus the minimum score
      is 17 and maximum score 85. A score of 17 has no features of PTSD and 85 the highest score
      for PTSD. When used as a screening tool, a score of more than 50 is considered to be
      diagnostic of PTSD.

      Completed questionnaires and consent forms will be kept in their folders and retained by the
      researchers.

      Following completion of their PCL-C forms, Group A participants will be treated using Thought
      Field Therapy by the newly trained therapists for their traumas, supervised by the
      researchers. The therapists will keep a record for each participant of the problem that was
      treated, algorithms used, the time taken, and the Subjective Units of Distress (SUD) scores
      (0-10).

      Group B will be a control (wait-list group) and will receive no treatment following their
      first visit. This model has been successfully utilised in Rwanda.

      One week later, at the same time and day of the week as they first attended, the participants
      in group A and group B will return and repeat their PCL. On this occasion, testing will be
      followed by treatment for Group B.

      After a further week, Group B only will return for repeat testing using PCL.

      In summary, the protocol to be followed will be:

        -  Two-day training of new therapists

        -  Day one of study: 9am - PCL test of 16 Group A and 16 Group B 11am -Treat the 16 Group A

           1pm - Test a new group of 16 A and 16 B 3pm - Treat the new 16 group A

        -  Days 2-4: Same as for day one, but with new participants. Each therapist will treat the
           same number in each group.

        -  Days 8-11 9am -PCL test of 16 Group A and 16 Group B 11am -Treat the 16 Group B

           1pm - Test another 16 of each Group 3pm -Treat the new Group B

        -  Day 18 Test all Group B, 16 every two hours from 9am

      Mean + SD PCL test scores will be calculated for each group during their four days of each
      week, and of Group B on day 18. That is:

      Group A days 1-4 (A pre-treatment) Group B days 1-4 (B pre-treatment) Group A days 8-11 (A
      post-treatment) Group B days 8-11 (B post-no treatment) Group B day 18 (B post-treatment)

      The statistical significance of differences of mean scores will be analysed by analysis of
      variance and paired samples t tests. Significances of differences in group proportions with
      diagnostic scores for PTSD will be assessed by a non-parametric test.

      Statistically significant differences were found in a similar study in Rwanda, with smaller
      numbers, so the study will be adequately powered.

      A follow-up assessment will be done 19 months later.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Post-traumatic Stress Disorder Check List for Civilians (PLC-C) Score.
time frame: Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)
description: PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. The wait list group received no treatment at Time 1.
In the treatment arm, measure immediately pre-treatment (baseline) (time 1) and one week later (time 2).
In the wait-list no therapy arm, measure at baseline (time 1), and after one week (no treatment) (time 2). The wait-list group (Thought Field Therapy group) were then treated and reassessed after a further week (time 3).
measure: Percentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.
time frame: Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)
description: PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. The wait list group received no treatment at Time 1.
arm group label: Thought Field Therapy
arm group type: Experimental
description: Thought Field Therapy delivered by trained community leaders.
arm group label: Wait list
arm group type: Other
description: Delayed intervention.
No intervention prior to assessment after one week (pre-test 2). Then treated with Thought Field Therapy, and re-assessed after a further week (post-test).
intervention type: Behavioral
intervention name: Thought Field Therapy.
description: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.
arm group label: Thought Field Therapy
arm group label: Wait list
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert H Robson, MA MB BChir
role: Principal Investigator
affiliation: Thought Field Therapy Foundation (UK) Ltd
facility: 
country: Uganda
url: http://en.wikipedia.org/wiki/Rwenzururu
description: Background to local conflicts potentially causing post-traumatic stress disorder.
url: http://www.tftfoundation.org
description: Co-sponsor
url: http://matsuldalhumanitarianfondation.wordpress.com/
description: Co-sponsor
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responsible party type: Principal Investigator
investigator affiliation: Thought Field Therapy Foundation (UK) Ltd
investigator full name: Robert Howard Robson
investigator title: Dr Robert Howard Robson
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: Yes
ipd description: Spreadsheet available on request. Individual paper copies also available.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Only one assessment tool for PTSD was used. The 19 month data interpretation was limited by the high drop-out rate.
point of contact: 