CompletedNCT01696578Updated Apr 24, 2014

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

An interventional study of BF-CBT and group physiotherapy in PTSD, Depression and Anxiety, sponsored by Rehabilitation and Research Centre for Torture Victims. Completed at 1 site in Kosovo. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-04-24.

Sponsored by Rehabilitation and Research Centre for Torture Victims · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 31
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the 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 studied

PTSD
Depression
Anxiety
Chronic Pain
Anger

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Keywords

PTSD
Depression
Anxiety
Chronic pain
Anger
Heart rate variability
Disability

In context

Stress Disorders, Post-Traumatic

2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.

This study's enrollment of 31 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

This is the only study on the registry with Rehabilitation and Research Centre for Torture Victims as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 31 participants (actual)

Study arms

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
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

Interventions

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

What researchers measure

Primary outcomes

Change of depression symptom from baseline at 3 and 6 months
Time frame: 0-3-6 months
Change of anxiety symptom from baseline at 3 and 6 months
Time frame: 0-3-6 months
Change of chronic pain symptom from baseline at 3 and 6 months
Time frame: 0-3-6 months
Change of anger from baseline at 3 and 6 months
Time frame: 0-3-6 months
Change of PTSD symptom from baseline at 3 and 6 months
Time frame: 0-3-6 months

Secondary outcomes

Change of disability scale from baseline at 3 and 6 months
Time frame: 0-3-6 months
Change of hand-grip strength from baseline at 3 and 6 months
Time frame: 0-3-6 months
Change of standing balance from baseline at 3 and 6 months
Time frame: 0-3-6 months
Change of BMI from baseline at 3 and 6 months
Time frame: 0-3-6 months
Change of heart rate variability from baseline at 3 and 6 months
Time frame: 0-3-6 months

Other outcomes

Change of reporting sleep disorder from baseline at 3 and 6 months
Time frame: 0-3-6 months
Change of reporting suicide ideation from baseline at 3 and 6 months
Time frame: 0-3-6 months

Study locations

1 site

Kosova Rehabilitation Centre for Torture Victims
Pristina, 10000, Kosovo

References and documents

Publications

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. PubMed 20509915 ↗
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. PubMed 20858274 ↗
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. PubMed 22846511 ↗
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. PubMed 28191034 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2012, a primary completion of Dec 2012 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 25, 2012
First posted: Oct 1, 2012
Start: Jan 2012
Primary completionActual: Dec 2012
CompletionActual: Apr 2014
Last update: Apr 24, 2014

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01696578
Lead sponsor: Rehabilitation and Research Centre for Torture Victims
Collaborators: Kosova Rehabilitation Centre for Torture Victims
Responsible party: Shr-Jie Wang (Principal investigator, Rehabilitation and Research Centre for Torture Victims) — Principal investigator
First posted: Oct 1, 2012
Start date: Jan 2012
Primary completion: Dec 2012
Completion: Apr 2014
Last update: Apr 24, 2014

Study contacts

Shr-Jie Wang, Ph.D.

principal investigator · Rehabilitation and Research Centre for Torture Victims

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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