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Completed

NCT Number: NCT01696578

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kosova Rehabilitation Centre for Torture Victims

Pristina, 10000, Kosovo

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BF-CBT and group physiotherapy

Behavioral

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

Primary outcomes

  1. Change of depression symptom from baseline at 3 and 6 months

    Time frame: 0-3-6 months

  2. Change of anxiety symptom from baseline at 3 and 6 months

    Time frame: 0-3-6 months

  3. Change of chronic pain symptom from baseline at 3 and 6 months

    Time frame: 0-3-6 months

  4. Change of anger from baseline at 3 and 6 months

    Time frame: 0-3-6 months

  5. Change of PTSD symptom from baseline at 3 and 6 months

    Time frame: 0-3-6 months

Secondary outcomes

  1. Change of disability scale from baseline at 3 and 6 months

    Time frame: 0-3-6 months

  2. Change of hand-grip strength from baseline at 3 and 6 months

    Time frame: 0-3-6 months

  3. Change of standing balance from baseline at 3 and 6 months

    Time frame: 0-3-6 months

  4. Change of BMI from baseline at 3 and 6 months

    Time frame: 0-3-6 months

  5. Change of heart rate variability from baseline at 3 and 6 months

    Time frame: 0-3-6 months

Other outcomes

  1. Change of reporting sleep disorder from baseline at 3 and 6 months

    Time frame: 0-3-6 months

  2. Change of reporting suicide ideation from baseline at 3 and 6 months

    Time frame: 0-3-6 months

Sponsors and collaborators

Lead sponsor

Rehabilitation and Research Centre for Torture Victims

Other

Collaborators

  • Kosova Rehabilitation Centre for Torture Victims

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2014
First posted
Oct 1, 2012
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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