Clinical trial NCT01696578: Effectiveness of Combined Intervention Approaches in the Treatment of Affective Disorders and Chronic Pain in War Victims
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Depression
Anxiety
Chronic Pain
Anger
Keywords: PTSD
Depression
Anxiety
Chronic pain
Anger
Heart rate variability
Disability
Lead sponsor: Rehabilitation and Research Centre for Torture Victims
Sponsor class: OTHER
Collaborators: name: Kosova Rehabilitation Centre for Torture Victims
First posted: 2012-10-01
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of depression symptom from baseline at 3 and 6 months
timeFrame: 0-3-6 months
measure: Change of anxiety symptom from baseline at 3 and 6 months
timeFrame: 0-3-6 months
measure: Change of chronic pain symptom from baseline at 3 and 6 months
timeFrame: 0-3-6 months
measure: Change of anger from baseline at 3 and 6 months
timeFrame: 0-3-6 months
measure: Change of PTSD symptom from baseline at 3 and 6 months
timeFrame: 0-3-6 months
Secondary outcomes:
measure: Change of disability scale from baseline at 3 and 6 months
timeFrame: 0-3-6 months
measure: Change of hand-grip strength from baseline at 3 and 6 months
timeFrame: 0-3-6 months
measure: Change of standing balance from baseline at 3 and 6 months
timeFrame: 0-3-6 months
measure: Change of BMI from baseline at 3 and 6 months
timeFrame: 0-3-6 months
measure: Change of heart rate variability from baseline at 3 and 6 months
timeFrame: 0-3-6 months
Other outcomes:
measure: Change of reporting sleep disorder from baseline at 3 and 6 months
timeFrame: 0-3-6 months
measure: Change of reporting suicide ideation from baseline at 3 and 6 months
timeFrame: 0-3-6 months
Locations:
city: Pristina
country: Kosovo
facility: Kosova Rehabilitation Centre for Torture Victims
Study officials:
affiliation: Rehabilitation and Research Centre for Torture Victims
name: Shr-Jie Wang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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.