<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/NCT04426448</url>
  </required_header>
  <id_info>
    <org_study_id>UBR/RES/IRB/BIO/179</org_study_id>
    <nct_id>NCT04426448</nct_id>
  </id_info>
  <brief_title>Assessment of a Brief Post Traumatic Stress Disorder Intervention for Use in Botswana</brief_title>
  <official_title>The Efficacy, Feasibility, and Acceptability of a Culturally Adapted Brief Intervention for Post-Traumatic Stress Disorder in Severe Mental Illness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Botswana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of KwaZulu</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Botswana</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to culturally adapt a brief psychological intervention for&#xD;
      Post-Traumatic Stress Disorder (PTSD) and assess its efficacy, feasibility, and acceptability&#xD;
      in a pilot trial. The intervention has been shown to be efficacious among individuals with&#xD;
      comorbid severe mental illness (SMI) and PTSD.&#xD;
&#xD;
      The study will be conducted in three phases. The first phase will determine a description of&#xD;
      trauma and responses to traumatic experiences among patients with severe mental illness. The&#xD;
      first phase of the study will also determine participants' and mental health care providers'&#xD;
      perceptions of suitable PTSD interventions in this middle-income context. The findings will&#xD;
      then be used to culturally adapt the brief intervention in the second phase. A pilot trial&#xD;
      will be conducted in the third phase of the study.&#xD;
&#xD;
      Participants with comorbid SMI and PTSD will be randomized into two groups (n= 20&#xD;
      intervention group, n= 20 control group). Outcomes of the intervention such as the severity&#xD;
      of PTSD symptoms, knowledge about PTSD will be assessed at baseline and at different&#xD;
      timelines during the study.&#xD;
&#xD;
      This study will fill the knowledge gap on trauma and its consequences among individuals with&#xD;
      severe mental illness in Botswana, it will also contribute to the improvement of clinical&#xD;
      practice in the management of PTSD and SMI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study participants will be recruited from Sbrana Psychiatric Hospital, the only referral&#xD;
      psychiatric hospital in Botswana. The hospital population is representative of the culturally&#xD;
      diverse Botswana nation because patients with severe mental illness from the entire country&#xD;
      are admitted to the hospital. Forty participants (40) will be recruited and randomized to&#xD;
      receive the Brief Relaxation, Education, And Trauma HEaling (BREATHE) intervention or&#xD;
      treatment as usual.&#xD;
&#xD;
      The intervention will be delivered by the Principal Investigator who has received training&#xD;
      from the intervention developer. Supervision will be provided telephonically.&#xD;
&#xD;
      The BREATHE intervention will be delivered weekly for each participant for a total of three&#xD;
      weeks and 4 participants will be enrolled per group resulting in a total of 5 groups. The&#xD;
      estimated period of intervention delivery and data collection is therefore expected to last&#xD;
      for a period of ~15 weeks.&#xD;
&#xD;
      Outcomes such as anxiety, depressive and PTSD Symptoms, and knowledge about PTSD will be&#xD;
      assessed before participants receive the intervention, weekly (following each treatment&#xD;
      session), month one and month three after treatment completion. Assessment of feasibility and&#xD;
      acceptability will be done at treatment completion with the intervention group. Participants&#xD;
      on the control arm will receive outcome measures at the same time points as those receiving&#xD;
      the intervention. The investigators will utilize an objective assessment of skin conductance&#xD;
      which has been shown to be greater in individuals with PTSD than in individuals without PTSD&#xD;
      and similarly increased during a trauma interview in individuals with PTSD compared to&#xD;
      individuals who do not have PTSD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Anticipated">September 29, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 29, 2021</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>
    <intervention_model_description>Participants will be randomized into two equal groups.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post Traumatic Checklist-5</measure>
    <time_frame>baseline, week 1, 2 ,3,</time_frame>
    <description>Mean Change from Baseline in the severity of PTSD symptoms as assessed with the PCL-5. Total scores for the Post Traumatic Checklist-5 range between 0 and 80 with a cut off score of 33 or higher suggesting the patient may benefit from PTSD treatment. Patients with scores lower than 33 may indicate the patient has sub-threshold symptoms of PTSD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>eSense EDA skin conductance device</measure>
    <time_frame>baseline, week 1, 2 ,3,</time_frame>
    <description>Change in physiological arousal as measured with sensors to assess skin conductance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mini International Neuropsychiatric Interview (MINI) Plus</measure>
    <time_frame>baseline, week 3, one month and three months post intervention</time_frame>
    <description>Assessment of symptoms meeting the criteria for PTSD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Consent rates</measure>
    <time_frame>week 3</time_frame>
    <description>to assess the acceptability of the intervention by dividing the number of participants who meet the criteria for PTSD and meet the inclusion criteria for the pilot trial by the number of those who consent to participate in the trial</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence rates</measure>
    <time_frame>week 3</time_frame>
    <description>to assess acceptability; measured by the total number of sessions attended by the participants and the reasons for non-adherence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>knowledge of PTSD scale (KPTSD)</measure>
    <time_frame>baseline, week 1, 2 ,3, one month and three months post intervention</time_frame>
    <description>mean difference in the scores obtained in the knowledge of PTSD scale. Higher scores indicate more knowledge of PTSD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of Intervention measure (AIM)</measure>
    <time_frame>week 3</time_frame>
    <description>Calculation of scores in the Acceptability of Intervention measure. Higher scores indicate greater acceptability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of Intervention Measure (FIM)</measure>
    <time_frame>week 3</time_frame>
    <description>calculation of scores in the Feasibility of Intervention Measure. Higher scores indicate greater feasibility</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient satisfaction scale</measure>
    <time_frame>week 3</time_frame>
    <description>calculation of scores in the satisfaction scale. Higher satisfaction with the intervention will be indicated by high scores on the patient satisfaction scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>baseline, week 1, 2 ,3, one month and three months post intervention</time_frame>
    <description>Mean Change from Baseline in the severity of depressive symptoms as assessed with the PHQ-9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Outcomes in Routine Evaluation-Outcome Measure</measure>
    <time_frame>baseline, week 3, one month and three months post intervention</time_frame>
    <description>Mean difference from Baseline in the severity of psychological distress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zung self-rating anxiety scale</measure>
    <time_frame>baseline, week 1, 2 ,3, one month and three months post intervention</time_frame>
    <description>Mean Change from Baseline in the severity of anxiety symptoms as assessed with the Zung anxiety rating scale. Total scores in the Zung self rating scale range from 20 to 80, with scores above 26 indicating severe and extremely severe anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post Traumatic Checklist-5</measure>
    <time_frame>one month and three months post intervention</time_frame>
    <description>Mean Change from Baseline in the severity of PTSD symptoms as assessed with the Post Traumatic Checklist-5. A five points difference in the total score is an indication that a patient has responded to treatment and 10 points has been determined as a minimum threshold for determining whether the improvement has clinical utility</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Post Traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive the BREATHE intervention for three weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants will receive treatment as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Relaxation, Education And Trauma HEaling</intervention_name>
    <description>A three-week psychological intervention for PTSD which comprise psychoeducation and breathing retraining to manage anxiety symptoms</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to understand Setswana or English&#xD;
&#xD;
          -  The patient must meet the Diagnostic and Statistical Manual of Mental Disorders, fifth&#xD;
             edition (DSM-5) criteria for any SMI as categorized for this study (schizophrenia,&#xD;
             schizophreniform disorder, schizoaffective disorder, bipolar mood disorder, and severe&#xD;
             depressive disorder)&#xD;
&#xD;
          -  The patient should meet the criteria for Post-Traumatic Stress Disorder as assessed&#xD;
             with the Post Traumatic Checklist-5 (PCL-5)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently engaged in psychotherapy for PTSD&#xD;
&#xD;
          -  On pharmacotherapy management of PTSD (to control for medication effects on PTSD&#xD;
             symptoms)&#xD;
&#xD;
          -  Inability to understand informed consent&#xD;
&#xD;
          -  Inability to respond to interview questions&#xD;
&#xD;
          -  Patients who have suicidal ideation and history of a suicide attempt within the past 6&#xD;
             months&#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>Keneilwe Molebatsi, MMED (Psych)</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Botswana</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Keneilwe Molebatsi, MMED (Psychiatry)</last_name>
    <phone>+26777458378</phone>
    <email>molebatsik@ub.ac..bw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Julia Gaorekwe</last_name>
    <phone>+2673552900</phone>
    <email>gaorekwej@ub.ac.bw</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sbrana Psychiatric Hospital</name>
      <address>
        <city>Lobatse</city>
        <zip>0000</zip>
        <country>Botswana</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sreekanth Davu, MD Psych</last_name>
      <phone>+26775877248</phone>
      <email>drsdavu@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Botswana</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>August 29, 2021</last_update_submitted>
  <last_update_submitted_qc>August 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Botswana</investigator_affiliation>
    <investigator_full_name>Keneilwe Molebatsi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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>The study will be conducted in fulfillment of a Doctor of Philosophy in Psychiatry degree. De-identified data will be shared with the supervisors</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Throughout the study period and one year after completion of write-up</ipd_time_frame>
    <ipd_access_criteria>de-identified coded data will be stored and shared as a statistical package for the social sciences (SPSS) file.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04426448
org study id: UBR/RES/IRB/BIO/179
nct id: NCT04426448
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to culturally adapt a brief psychological intervention for
      Post-Traumatic Stress Disorder (PTSD) and assess its efficacy, feasibility, and acceptability
      in a pilot trial. The intervention has been shown to be efficacious among individuals with
      comorbid severe mental illness (SMI) and PTSD.

      The study will be conducted in three phases. The first phase will determine a description of
      trauma and responses to traumatic experiences among patients with severe mental illness. The
      first phase of the study will also determine participants' and mental health care providers'
      perceptions of suitable PTSD interventions in this middle-income context. The findings will
      then be used to culturally adapt the brief intervention in the second phase. A pilot trial
      will be conducted in the third phase of the study.

      Participants with comorbid SMI and PTSD will be randomized into two groups (n= 20
      intervention group, n= 20 control group). Outcomes of the intervention such as the severity
      of PTSD symptoms, knowledge about PTSD will be assessed at baseline and at different
      timelines during the study.

      This study will fill the knowledge gap on trauma and its consequences among individuals with
      severe mental illness in Botswana, it will also contribute to the improvement of clinical
      practice in the management of PTSD and SMI.
Study participants will be recruited from Sbrana Psychiatric Hospital, the only referral
      psychiatric hospital in Botswana. The hospital population is representative of the culturally
      diverse Botswana nation because patients with severe mental illness from the entire country
      are admitted to the hospital. Forty participants (40) will be recruited and randomized to
      receive the Brief Relaxation, Education, And Trauma HEaling (BREATHE) intervention or
      treatment as usual.

      The intervention will be delivered by the Principal Investigator who has received training
      from the intervention developer. Supervision will be provided telephonically.

      The BREATHE intervention will be delivered weekly for each participant for a total of three
      weeks and 4 participants will be enrolled per group resulting in a total of 5 groups. The
      estimated period of intervention delivery and data collection is therefore expected to last
      for a period of ~15 weeks.

      Outcomes such as anxiety, depressive and PTSD Symptoms, and knowledge about PTSD will be
      assessed before participants receive the intervention, weekly (following each treatment
      session), month one and month three after treatment completion. Assessment of feasibility and
      acceptability will be done at treatment completion with the intervention group. Participants
      on the control arm will receive outcome measures at the same time points as those receiving
      the intervention. The investigators will utilize an objective assessment of skin conductance
      which has been shown to be greater in individuals with PTSD than in individuals without PTSD
      and similarly increased during a trauma interview in individuals with PTSD compared to
      individuals who do not have PTSD.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized into two equal groups.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Post Traumatic Checklist-5
time frame: baseline, week 1, 2 ,3,
description: Mean Change from Baseline in the severity of PTSD symptoms as assessed with the PCL-5. Total scores for the Post Traumatic Checklist-5 range between 0 and 80 with a cut off score of 33 or higher suggesting the patient may benefit from PTSD treatment. Patients with scores lower than 33 may indicate the patient has sub-threshold symptoms of PTSD
measure: eSense EDA skin conductance device
time frame: baseline, week 1, 2 ,3,
description: Change in physiological arousal as measured with sensors to assess skin conductance
measure: Mini International Neuropsychiatric Interview (MINI) Plus
time frame: baseline, week 3, one month and three months post intervention
description: Assessment of symptoms meeting the criteria for PTSD
measure: Consent rates
time frame: week 3
description: to assess the acceptability of the intervention by dividing the number of participants who meet the criteria for PTSD and meet the inclusion criteria for the pilot trial by the number of those who consent to participate in the trial
measure: Adherence rates
time frame: week 3
description: to assess acceptability; measured by the total number of sessions attended by the participants and the reasons for non-adherence.
measure: knowledge of PTSD scale (KPTSD)
time frame: baseline, week 1, 2 ,3, one month and three months post intervention
description: mean difference in the scores obtained in the knowledge of PTSD scale. Higher scores indicate more knowledge of PTSD.
measure: Acceptability of Intervention measure (AIM)
time frame: week 3
description: Calculation of scores in the Acceptability of Intervention measure. Higher scores indicate greater acceptability
measure: Feasibility of Intervention Measure (FIM)
time frame: week 3
description: calculation of scores in the Feasibility of Intervention Measure. Higher scores indicate greater feasibility
measure: Patient satisfaction scale
time frame: week 3
description: calculation of scores in the satisfaction scale. Higher satisfaction with the intervention will be indicated by high scores on the patient satisfaction scale
measure: Patient Health Questionnaire-9 (PHQ-9)
time frame: baseline, week 1, 2 ,3, one month and three months post intervention
description: Mean Change from Baseline in the severity of depressive symptoms as assessed with the PHQ-9
measure: Clinical Outcomes in Routine Evaluation-Outcome Measure
time frame: baseline, week 3, one month and three months post intervention
description: Mean difference from Baseline in the severity of psychological distress
measure: Zung self-rating anxiety scale
time frame: baseline, week 1, 2 ,3, one month and three months post intervention
description: Mean Change from Baseline in the severity of anxiety symptoms as assessed with the Zung anxiety rating scale. Total scores in the Zung self rating scale range from 20 to 80, with scores above 26 indicating severe and extremely severe anxiety.
measure: Post Traumatic Checklist-5
time frame: one month and three months post intervention
description: Mean Change from Baseline in the severity of PTSD symptoms as assessed with the Post Traumatic Checklist-5. A five points difference in the total score is an indication that a patient has responded to treatment and 10 points has been determined as a minimum threshold for determining whether the improvement has clinical utility
arm group label: Intervention group
arm group type: Experimental
description: Participants will receive the BREATHE intervention for three weeks
arm group label: Control group
arm group type: No Intervention
description: The participants will receive treatment as usual
intervention type: Behavioral
intervention name: Brief Relaxation, Education And Trauma HEaling
description: A three-week psychological intervention for PTSD which comprise psychoeducation and breathing retraining to manage anxiety symptoms
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Keneilwe Molebatsi, MMED (Psych)
role: Principal Investigator
affiliation: University of Botswana
last name: Keneilwe Molebatsi, MMED (Psychiatry)
phone: +26777458378
email: molebatsik@ub.ac..bw
last name: Julia Gaorekwe
phone: +2673552900
email: gaorekwej@ub.ac.bw
facility: 
status: Recruiting
contact: 
country: Botswana
responsible party type: Principal Investigator
investigator affiliation: University of Botswana
investigator full name: Keneilwe Molebatsi
investigator title: Principal Investigator
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: Yes
ipd description: The study will be conducted in fulfillment of a Doctor of Philosophy in Psychiatry degree. De-identified data will be shared with the supervisors
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Throughout the study period and one year after completion of write-up
ipd access criteria: de-identified coded data will be stored and shared as a statistical package for the social sciences (SPSS) file.