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

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

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.

Study Overview

• Status: Completed
• Conditions: Anger; Depression; PTSD; Chronic Pain; Anxiety
• Intervention / Treatment: Behavioral: BF-CBT and group physiotherapy

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kosovo
  • Pristina, Kosovo, 10000
    • Kosova Rehabilitation Centre for Torture Victims

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BF-CBT and group physiotherapy; Multivitamin+10 sessions of biofeedback supported cognitive behavioral therapy (BF-CBT) and 10 sessions of group physiotherapy	Behavioral: BF-CBT and group physiotherapy; Multivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis
Active Comparator: Waiting list; 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; Multivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
Change of reporting sleep disorder from baseline at 3 and 6 months	0-3-6 months
Change of reporting suicide ideation from baseline at 3 and 6 months	0-3-6 months

Collaborators and Investigators

• Sponsor: Rehabilitation and Research Centre for Torture Victims
• Collaborators: Kosova Rehabilitation Centre for Torture Victims
• Investigators: Principal Investigator: Shr-Jie Wang, Ph.D., Rehabilitation and Research Centre for Torture Victims

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Wang SJ, Bytyci A, Izeti S, Kallaba M, Rushiti F, Montgomery E, Modvig J. A novel bio-psycho-social approach for rehabilitation of traumatized victims of torture and war in the post-conflict context: a pilot randomized controlled trial in Kosovo. Confl Health. 2017 Feb 8;10:34. doi: 10.1186/s13031-016-0100-y. eCollection 2016.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: September 25, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (Estimate): October 1, 2012

Study Record Updates

• Last Update Posted (Estimate): April 24, 2014
• Last Update Submitted That Met QC Criteria: April 23, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: PTSD; Depression; Anxiety; Chronic pain; Anger; Disability; Heart rate variability
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pain; Neurologic Manifestations; Depression; Chronic Pain; Mood Disorders
• Other Study ID Numbers: RCTF5S2P4D1