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

Not Applicable

Completed

• Conditions: Anxiety; PTSD; Depression; Chronic Pain; Anger
• Interventions: Behavioral: BF-CBT and group physiotherapy

• Registration Number: NCT01696578
• Lead Sponsor: Rehabilitation and Research Centre for Torture Victims

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-10-01
• Primary Completion: 2012-12
• Status Verified: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-23
• Last Update Posted: 2014-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BF-CBT and group physiotherapy	BF-CBT and group physiotherapy	Multivitamin+10 sessions of biofeedback supported cognitive behavioral therapy (BF-CBT) and 10 sessions of group physiotherapy
Waiting list	BF-CBT and group physiotherapy	The waiting list group receives only multivitamin pills while being waiting and will receive the same intervention 3 months later

Primary Outcome Measures

Name	Time	Method
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 PTSD symptom from baseline at 3 and 6 months	0-3-6 months
Change of depression 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

Secondary Outcome Measures

Name	Time	Method
Change of heart rate variability from baseline at 3 and 6 months	0-3-6 months
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

Trial Locations

Locations (1)

Kosova Rehabilitation Centre for Torture Victims; Pristina, Kosovo