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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696578
• Other study ID #: RCTF5S2P4D1
• Status: Completed
• Phase: N/A
• First received: September 25, 2012
• Last updated: April 23, 2014
• Start date: January 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Rehabilitation and Research Centre for Torture Victims
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethical Professional Board, Ministry of Health:Kosovo
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anger
• Anxiety
• Chronic Pain
• Depression
• Mood Disorders
• PTSD

Intervention

Behavioral:
• BF-CBT and group physiotherapy
Multivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis

Locations

Country	Name	City	State
Kosovo	Kosova Rehabilitation Centre for Torture Victims	Pristina

Sponsors (2)

Lead Sponsor	Collaborator
Rehabilitation and Research Centre for Torture Victims	Kosova Rehabilitation Centre for Torture Victims

Country where clinical trial is conducted

Kosovo, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of reporting sleep disorder from baseline at 3 and 6 months		0-3-6 months	No
Other	Change of reporting suicide ideation from baseline at 3 and 6 months		0-3-6 months	No
Primary	Change of depression symptom from baseline at 3 and 6 months		0-3-6 months	No
Primary	Change of anxiety symptom from baseline at 3 and 6 months		0-3-6 months	No
Primary	Change of chronic pain symptom from baseline at 3 and 6 months		0-3-6 months	No
Primary	Change of anger from baseline at 3 and 6 months		0-3-6 months	No
Primary	Change of PTSD symptom from baseline at 3 and 6 months		0-3-6 months	No
Secondary	Change of disability scale from baseline at 3 and 6 months		0-3-6 months	No
Secondary	Change of hand-grip strength from baseline at 3 and 6 months		0-3-6 months	No
Secondary	Change of standing balance from baseline at 3 and 6 months		0-3-6 months	No
Secondary	Change of BMI from baseline at 3 and 6 months		0-3-6 months	No
Secondary	Change of heart rate variability from baseline at 3 and 6 months		0-3-6 months	Yes