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

NCT ID: NCT01696578

Last Updated: 2014-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-04-30

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.

Conditions

PTSD; Depression; Anxiety; Chronic Pain; Anger

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BF-CBT and group physiotherapy

Multivitamin+10 sessions of biofeedback supported cognitive behavioral therapy (BF-CBT) and 10 sessions of group physiotherapy

Group Type: EXPERIMENTAL

BF-CBT and group physiotherapy

Intervention Type: BEHAVIORAL

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

Waiting list

The waiting list group receives only multivitamin pills while being waiting and will receive the same intervention 3 months later

Group Type: ACTIVE_COMPARATOR

BF-CBT and group physiotherapy

Intervention Type: BEHAVIORAL

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

Interventions

BF-CBT and group physiotherapy

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kosova Rehabilitation Centre for Torture Victims

OTHER

Sponsor Role: collaborator

Rehabilitation and Research Centre for Torture Victims

OTHER

Sponsor Role: lead

Responsible Party

Shr-Jie Wang

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shr-Jie Wang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rehabilitation and Research Centre for Torture Victims

Locations

Kosova Rehabilitation Centre for Torture Victims

Pristina, , Kosovo

Countries

Kosovo

References

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.

Reference Type: BACKGROUND

PMID: 20509915 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20858274 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22846511 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28191034 (View on PubMed)

Other Identifiers

RCTF5S2P4D1

Identifier Type: -

Identifier Source: org_study_id