Effectiveness of Combined Intervention Approaches in the Treatment of Affective Disorders and Chronic Pain in War Victims

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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PTSD, Depression, Anxiety, Chronic Pain, Anger

Intervention / Treatment
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* Behavioral: BF-CBT and group physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Victims of massive violence from northern Kosovo who reported one or more of the following experiences: 1) torture and other cruel, inhuman or degrading treatment or punishment (TCIDTP); 2) sexual harassment, molestation, rape or insertion of a blunt object into a genital organ and/or the rectum; 3) arrest and detention without warrant or order; or 4) extrajudicial execution of family members, perpetrated by members of law enforcement agency. Clinical diagnosis of PTSD and one of following symptoms: depression, anxiety or chronic pain Exclusion Criteria: With mental retardation or significant speech or cognitive impairment that would impede assessments With past or present schizophrenia With major alcoholic or substance abuse problems Having recently undergone chemotherapy or chemo-radiotherapy for cancer or will have these therapy within following 6 months, Having had any CBT in the past three years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BF-CBT and group physiotherapy<br>Multivitamin+10 sessions of biofeedback supported cognitive behavioral therapy (BF-CBT) and 10 sessions of group physiotherapy | Behavioral: BF-CBT and group physiotherapy<br>* Multivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis<br>|
| Active Comparator: Waiting list<br>The waiting list group receives only multivitamin pills while being waiting and will receive the same intervention 3 months later | Behavioral: BF-CBT and group physiotherapy<br>* Multivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of depression symptom from baseline at 3 and 6 months |  | 0-3-6 months | 
| Change of anxiety symptom from baseline at 3 and 6 months |  | 0-3-6 months | 
| Change of chronic pain symptom from baseline at 3 and 6 months |  | 0-3-6 months | 
| Change of anger from baseline at 3 and 6 months |  | 0-3-6 months | 
| Change of PTSD symptom from baseline at 3 and 6 months |  | 0-3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of disability scale from baseline at 3 and 6 months |  | 0-3-6 months | 
| Change of hand-grip strength from baseline at 3 and 6 months |  | 0-3-6 months | 
| Change of standing balance from baseline at 3 and 6 months |  | 0-3-6 months | 
| Change of BMI from baseline at 3 and 6 months |  | 0-3-6 months | 
| Change of heart rate variability from baseline at 3 and 6 months |  | 0-3-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Depression, Anxiety, Chronic pain, Anger, Heart rate variability, Disability