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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kosova Rehabilitation Centre for Torture Victims
Information provided by (Responsible Party):
Shr-Jie Wang, Rehabilitation and Research Centre for Torture Victims
ClinicalTrials.gov Identifier:
NCT01696578
First received: September 25, 2012
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
PTSD
Depression
Anxiety
Chronic Pain
Anger
 Behavioral: BF-CBT and group physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rehabilitation and Research Centre for Torture Victims:

Primary Outcome Measures:
  • Change of depression symptom from baseline at 3 and 6 months [ Time Frame: 0-3-6 months ] [ Designated as safety issue: No ]
  • Change of anxiety symptom from baseline at 3 and 6 months [ Time Frame: 0-3-6 months ] [ Designated as safety issue: No ]
  • Change of chronic pain symptom from baseline at 3 and 6 months [ Time Frame: 0-3-6 months ] [ Designated as safety issue: No ]
  • Change of anger from baseline at 3 and 6 months [ Time Frame: 0-3-6 months ] [ Designated as safety issue: No ]
  • Change of PTSD symptom from baseline at 3 and 6 months [ Time Frame: 0-3-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of disability scale from baseline at 3 and 6 months [ Time Frame: 0-3-6 months ] [ Designated as safety issue: No ]
  • Change of hand-grip strength from baseline at 3 and 6 months [ Time Frame: 0-3-6 months ] [ Designated as safety issue: No ]
  • Change of standing balance from baseline at 3 and 6 months [ Time Frame: 0-3-6 months ] [ Designated as safety issue: No ]
  • Change of BMI from baseline at 3 and 6 months [ Time Frame: 0-3-6 months ] [ Designated as safety issue: No ]
  • Change of heart rate variability from baseline at 3 and 6 months [ Time Frame: 0-3-6 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Change of reporting sleep disorder from baseline at 3 and 6 months [ Time Frame: 0-3-6 months ] [ Designated as safety issue: No ]
  • Change of reporting suicide ideation from baseline at 3 and 6 months [ Time Frame: 0-3-6 months ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696578

Locations
Kosovo
Kosova Rehabilitation Centre for Torture Victims
Pristina, Kosovo, 10000
Sponsors and Collaborators
Rehabilitation and Research Centre for Torture Victims
Kosova Rehabilitation Centre for Torture Victims
Investigators
Principal Investigator: Shr-Jie Wang, Ph.D. Rehabilitation and Research Centre for Torture Victims
  More Information

Publications:

Responsible Party: Shr-Jie Wang, Principal investigator, Rehabilitation and Research Centre for Torture Victims
ClinicalTrials.gov Identifier: NCT01696578     History of Changes
Other Study ID Numbers: RCTF5S2P4D1
Study First Received: September 25, 2012
Last Updated: September 27, 2012
Health Authority: Ethical Professional Board, Ministry of Health:Kosovo

Keywords provided by Rehabilitation and Research Centre for Torture Victims:
PTSD
Depression
Anxiety
Chronic pain
 Anger
Heart rate variability
Disability

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
 Mood Disorders
Mental Disorders
Behavioral Symptoms
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on May 19, 2013