<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/NCT01696578</url>
  </required_header>
  <id_info>
    <org_study_id>RCTF5S2P4D1</org_study_id>
    <nct_id>NCT01696578</nct_id>
  </id_info>
  <brief_title>Effectiveness of Combined Intervention Approaches in the Treatment of Affective Disorders and Chronic Pain in War Victims</brief_title>
  <official_title>Effectiveness of Combined Intervention Approaches in the Treatment of Affective Disorders and Chronic Pain in Victims of Torture and Massive Violence in Kosovo: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rehabilitation and Research Centre for Torture Victims</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kosova Rehabilitation Centre for Torture Victims</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rehabilitation and Research Centre for Torture Victims</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will measure the effects of biofeedback supported cognitive behavioral therapy&#xD;
      (BF-CBT) and group physiotherapy intervention in victims of torture and massive violence in&#xD;
      Kosovo. The investigators aim to restore physical and psychosocial functioning of the victims&#xD;
      of torture and massive violence with available rehabilitation practice and integrate them&#xD;
      into the community. It is also our objective to build local knowledge and expertise to apply&#xD;
      measurement principles and CBT methods in the Balkan region.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this project is to contribute to the promotion of evidence-based&#xD;
      health intervention which is dealing with the long-term consequences of trauma in the&#xD;
      post-conflict Kosovo.&#xD;
&#xD;
      This is the second phase of a series of multi-site case studies. Based on the knowledge&#xD;
      generated in the first phase of project in 2007-2009, the investigators conclude that there&#xD;
      is a need to continue with health interventions in northern Kosovo among those who are still&#xD;
      suffering from the long-term effects of trauma. Many problems need to be addressed, ranging&#xD;
      from unemployment and sleep disturbances to a high suicide rate. As our study shows, the&#xD;
      situation is frequently complicated by co-morbidity between mental and physical problems, in&#xD;
      particular, anger, hatred, severe depression and chronic pain.&#xD;
&#xD;
      At this phase, the investigators aim to provide the available rehabilitation service to the&#xD;
      victims of torture and massive violence in northern Kosovo. The investigators undertake an&#xD;
      integrated intervention approach; that is a biofeedback supported cognitive-behavioral&#xD;
      therapy (BF-CBT), which involves anger management, anxiety and phobia treatment (based on&#xD;
      prolong exposure therapy)and a group physiotherapy intervention, which promotes physical&#xD;
      fitness and social participation. The ultimate goal of this project is to determine both&#xD;
      feasibility and the effectiveness of combined interventions in the countries with limited&#xD;
      resources.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">December 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of depression symptom from baseline at 3 and 6 months</measure>
    <time_frame>0-3-6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of anxiety symptom from baseline at 3 and 6 months</measure>
    <time_frame>0-3-6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of chronic pain symptom from baseline at 3 and 6 months</measure>
    <time_frame>0-3-6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of anger from baseline at 3 and 6 months</measure>
    <time_frame>0-3-6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of PTSD symptom from baseline at 3 and 6 months</measure>
    <time_frame>0-3-6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of disability scale from baseline at 3 and 6 months</measure>
    <time_frame>0-3-6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of hand-grip strength from baseline at 3 and 6 months</measure>
    <time_frame>0-3-6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of standing balance from baseline at 3 and 6 months</measure>
    <time_frame>0-3-6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of BMI from baseline at 3 and 6 months</measure>
    <time_frame>0-3-6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of heart rate variability from baseline at 3 and 6 months</measure>
    <time_frame>0-3-6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change of reporting sleep disorder from baseline at 3 and 6 months</measure>
    <time_frame>0-3-6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change of reporting suicide ideation from baseline at 3 and 6 months</measure>
    <time_frame>0-3-6 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>PTSD</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <condition>Chronic Pain</condition>
  <condition>Anger</condition>
  <arm_group>
    <arm_group_label>BF-CBT and group physiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multivitamin+10 sessions of biofeedback supported cognitive behavioral therapy (BF-CBT) and 10 sessions of group physiotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting list</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The waiting list group receives only multivitamin pills while being waiting and will receive the same intervention 3 months later</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BF-CBT and group physiotherapy</intervention_name>
    <description>Multivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis</description>
    <arm_group_label>BF-CBT and group physiotherapy</arm_group_label>
    <arm_group_label>Waiting list</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Victims of massive violence from northern Kosovo who reported one or more of the&#xD;
             following experiences: 1) torture and other cruel, inhuman or degrading treatment or&#xD;
             punishment (TCIDTP); 2) sexual harassment, molestation, rape or insertion of a blunt&#xD;
             object into a genital organ and/or the rectum; 3) arrest and detention without warrant&#xD;
             or order; or 4) extrajudicial execution of family members, perpetrated by members of&#xD;
             law enforcement agency.&#xD;
&#xD;
          -  Clinical diagnosis of PTSD and one of following symptoms: depression, anxiety or&#xD;
             chronic pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With mental retardation or significant speech or cognitive impairment that would&#xD;
             impede assessments&#xD;
&#xD;
          -  With past or present schizophrenia&#xD;
&#xD;
          -  With major alcoholic or substance abuse problems&#xD;
&#xD;
          -  Having recently undergone chemotherapy or chemo-radiotherapy for cancer or will have&#xD;
             these therapy within following 6 months,&#xD;
&#xD;
          -  Having had any CBT in the past three years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shr-Jie Wang, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rehabilitation and Research Centre for Torture Victims</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kosova Rehabilitation Centre for Torture Victims</name>
      <address>
        <city>Pristina</city>
        <zip>10000</zip>
        <country>Kosovo</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kosovo</country>
  </location_countries>
  <reference>
    <citation>Wang SJ, Salihu M, Rushiti F, Bala L, Modvig J. Survivors of the war in the Northern Kosovo: violence exposure, risk factors and public health effects of an ethnic conflict. Confl Health. 2010 May 28;4:11. doi: 10.1186/1752-1505-4-11.</citation>
    <PMID>20509915</PMID>
  </reference>
  <reference>
    <citation>Wang SJ, Pacolli S, Rushiti F, Rexhaj B, Modvig J. Survivors of war in the Northern Kosovo (II): baseline clinical and functional assessment and lasting effects on the health of a vulnerable population. Confl Health. 2010 Sep 21;4:16. doi: 10.1186/1752-1505-4-16.</citation>
    <PMID>20858274</PMID>
  </reference>
  <reference>
    <citation>Wang SJ, Rushiti F, Sejdiu X, Pacolli S, Gashi B, Salihu F, Modvig J. Survivors of war in northern Kosovo (III): The role of anger and hatred in pain and PTSD and their interactive effects on career outcome, quality of sleep and suicide ideation. Confl Health. 2012 Jul 30;6(1):4. doi: 10.1186/1752-1505-6-4.</citation>
    <PMID>22846511</PMID>
  </reference>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>April 23, 2014</last_update_submitted>
  <last_update_submitted_qc>April 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rehabilitation and Research Centre for Torture Victims</investigator_affiliation>
    <investigator_full_name>Shr-Jie Wang</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>PTSD</keyword>
  <keyword>Depression</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Chronic pain</keyword>
  <keyword>Anger</keyword>
  <keyword>Heart rate variability</keyword>
  <keyword>Disability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Mood Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT01696578
org study id: RCTF5S2P4D1
nct id: NCT01696578
lead sponsor: 
collaborator: 
has dmc: Yes
This study will measure the effects of biofeedback supported cognitive behavioral therapy
      (BF-CBT) and group physiotherapy intervention in victims of torture and massive violence in
      Kosovo. The investigators aim to restore physical and psychosocial functioning of the victims
      of torture and massive violence with available rehabilitation practice and integrate them
      into the community. It is also our objective to build local knowledge and expertise to apply
      measurement principles and CBT methods in the Balkan region.
The primary objective of this project is to contribute to the promotion of evidence-based
      health intervention which is dealing with the long-term consequences of trauma in the
      post-conflict Kosovo.

      This is the second phase of a series of multi-site case studies. Based on the knowledge
      generated in the first phase of project in 2007-2009, the investigators conclude that there
      is a need to continue with health interventions in northern Kosovo among those who are still
      suffering from the long-term effects of trauma. Many problems need to be addressed, ranging
      from unemployment and sleep disturbances to a high suicide rate. As our study shows, the
      situation is frequently complicated by co-morbidity between mental and physical problems, in
      particular, anger, hatred, severe depression and chronic pain.

      At this phase, the investigators aim to provide the available rehabilitation service to the
      victims of torture and massive violence in northern Kosovo. The investigators undertake an
      integrated intervention approach; that is a biofeedback supported cognitive-behavioral
      therapy (BF-CBT), which involves anger management, anxiety and phobia treatment (based on
      prolong exposure therapy)and a group physiotherapy intervention, which promotes physical
      fitness and social participation. The ultimate goal of this project is to determine both
      feasibility and the effectiveness of combined interventions in the countries with limited
      resources.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change of depression symptom from baseline at 3 and 6 months
time frame: 0-3-6 months
measure: Change of anxiety symptom from baseline at 3 and 6 months
time frame: 0-3-6 months
measure: Change of chronic pain symptom from baseline at 3 and 6 months
time frame: 0-3-6 months
measure: Change of anger from baseline at 3 and 6 months
time frame: 0-3-6 months
measure: Change of PTSD symptom from baseline at 3 and 6 months
time frame: 0-3-6 months
measure: Change of disability scale from baseline at 3 and 6 months
time frame: 0-3-6 months
measure: Change of hand-grip strength from baseline at 3 and 6 months
time frame: 0-3-6 months
measure: Change of standing balance from baseline at 3 and 6 months
time frame: 0-3-6 months
measure: Change of BMI from baseline at 3 and 6 months
time frame: 0-3-6 months
measure: Change of heart rate variability from baseline at 3 and 6 months
time frame: 0-3-6 months
measure: Change of reporting sleep disorder from baseline at 3 and 6 months
time frame: 0-3-6 months
measure: Change of reporting suicide ideation from baseline at 3 and 6 months
time frame: 0-3-6 months
arm group label: BF-CBT and group physiotherapy
arm group type: Experimental
description: Multivitamin+10 sessions of biofeedback supported cognitive behavioral therapy (BF-CBT) and 10 sessions of group physiotherapy
arm group label: Waiting list
arm group type: Active Comparator
description: The waiting list group receives only multivitamin pills while being waiting and will receive the same intervention 3 months later
intervention type: Behavioral
intervention name: BF-CBT and group physiotherapy
description: Multivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis
arm group label: BF-CBT and group physiotherapy
arm group label: Waiting list
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Shr-Jie Wang, Ph.D.
role: Principal Investigator
affiliation: Rehabilitation and Research Centre for Torture Victims
facility: 
country: Kosovo
citation: Wang SJ, Salihu M, Rushiti F, Bala L, Modvig J. Survivors of the war in the Northern Kosovo: violence exposure, risk factors and public health effects of an ethnic conflict. Confl Health. 2010 May 28;4:11. doi: 10.1186/1752-1505-4-11.
PMID: 20509915
citation: Wang SJ, Pacolli S, Rushiti F, Rexhaj B, Modvig J. Survivors of war in the Northern Kosovo (II): baseline clinical and functional assessment and lasting effects on the health of a vulnerable population. Confl Health. 2010 Sep 21;4:16. doi: 10.1186/1752-1505-4-16.
PMID: 20858274
citation: Wang SJ, Rushiti F, Sejdiu X, Pacolli S, Gashi B, Salihu F, Modvig J. Survivors of war in northern Kosovo (III): The role of anger and hatred in pain and PTSD and their interactive effects on career outcome, quality of sleep and suicide ideation. Confl Health. 2012 Jul 30;6(1):4. doi: 10.1186/1752-1505-6-4.
PMID: 22846511
responsible party type: Principal Investigator
investigator affiliation: Rehabilitation and Research Centre for Torture Victims
investigator full name: Shr-Jie Wang
investigator title: Principal investigator
mesh term: Chronic Pain
mesh term: Depression
mesh term: Mood Disorders