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

Primary Purpose

PTSD, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Kosovo
Study Type
Interventional
Intervention
BF-CBT and group physiotherapy
Sponsored by
Rehabilitation and Research Centre for Torture Victims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, Depression, Anxiety, Chronic pain, Anger, Heart rate variability, Disability

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kosova Rehabilitation Centre for Torture Victims

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BF-CBT and group physiotherapy

Waiting list

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of depression symptom from baseline at 3 and 6 months
Change of anxiety symptom from baseline at 3 and 6 months
Change of chronic pain symptom from baseline at 3 and 6 months
Change of anger from baseline at 3 and 6 months
Change of PTSD symptom from baseline at 3 and 6 months

Secondary Outcome Measures

Change of disability scale from baseline at 3 and 6 months
Change of hand-grip strength from baseline at 3 and 6 months
Change of standing balance from baseline at 3 and 6 months
Change of BMI from baseline at 3 and 6 months
Change of heart rate variability from baseline at 3 and 6 months

Full Information

First Posted
September 25, 2012
Last Updated
April 23, 2014
Sponsor
Rehabilitation and Research Centre for Torture Victims
Collaborators
Kosova Rehabilitation Centre for Torture Victims
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1. Study Identification

Unique Protocol Identification Number
NCT01696578
Brief Title
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rehabilitation and Research Centre for Torture Victims
Collaborators
Kosova Rehabilitation Centre for Torture Victims

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Depression, Anxiety, Chronic Pain, Anger
Keywords
PTSD, Depression, Anxiety, Chronic pain, Anger, Heart rate variability, Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BF-CBT and group physiotherapy
Arm Type
Experimental
Arm Description
Multivitamin+10 sessions of biofeedback supported cognitive behavioral therapy (BF-CBT) and 10 sessions of group physiotherapy
Arm Title
Waiting list
Arm Type
Active Comparator
Arm Description
The waiting list group receives only multivitamin pills while being waiting and will receive the same intervention 3 months later
Intervention Type
Behavioral
Intervention Name(s)
BF-CBT and group physiotherapy
Intervention Description
Multivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis
Primary Outcome Measure Information:
Title
Change of depression symptom from baseline at 3 and 6 months
Time Frame
0-3-6 months
Title
Change of anxiety symptom from baseline at 3 and 6 months
Time Frame
0-3-6 months
Title
Change of chronic pain symptom from baseline at 3 and 6 months
Time Frame
0-3-6 months
Title
Change of anger from baseline at 3 and 6 months
Time Frame
0-3-6 months
Title
Change of PTSD symptom from baseline at 3 and 6 months
Time Frame
0-3-6 months
Secondary Outcome Measure Information:
Title
Change of disability scale from baseline at 3 and 6 months
Time Frame
0-3-6 months
Title
Change of hand-grip strength from baseline at 3 and 6 months
Time Frame
0-3-6 months
Title
Change of standing balance from baseline at 3 and 6 months
Time Frame
0-3-6 months
Title
Change of BMI from baseline at 3 and 6 months
Time Frame
0-3-6 months
Title
Change of heart rate variability from baseline at 3 and 6 months
Time Frame
0-3-6 months
Other Pre-specified Outcome Measures:
Title
Change of reporting sleep disorder from baseline at 3 and 6 months
Time Frame
0-3-6 months
Title
Change of reporting suicide ideation from baseline at 3 and 6 months
Time Frame
0-3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shr-Jie Wang, Ph.D.
Organizational Affiliation
Rehabilitation and Research Centre for Torture Victims
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kosova Rehabilitation Centre for Torture Victims
City
Pristina
ZIP/Postal Code
10000
Country
Kosovo

12. IPD Sharing Statement

Citations:
PubMed Identifier
20509915
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.
Results Reference
background
PubMed Identifier
20858274
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.
Results Reference
background
PubMed Identifier
22846511
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.
Results Reference
background
PubMed Identifier
28191034
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.
Results Reference
derived

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

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