PTSDNCT01696578
Effectiveness of Combined Intervention Approaches in the Treatment of Affective Disorders and Chronic Pain in War Victims
A study testing BF-CBT and group physiotherapy in people with PTSD and Depression, run by Rehabilitation and Research Centre for Torture Victims at 1 site in Kosovo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD, Depression, Anxiety
- What is being tested?
- BF-CBT and group physiotherapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteKosovo
- Study dates
- Jan 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- PTSD, Depression, Anxiety, Chronic Pain, Anger
- Being tested
- BF-CBT and group physiotherapy
- Keywords
- PTSD, Depression, Anxiety, Chronic pain, Anger, Heart rate variability, Disability
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BF-CBT and group physiotherapyBehavioural
Multivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis
| Study group | Role | What they receive |
|---|---|---|
| BF-CBT and group physiotherapy | Experimental | Multivitamin+10 sessions of biofeedback supported cognitive behavioral therapy (BF-CBT) and 10 sessions of group physiotherapy Receives: Behavioral: BF-CBT and group physiotherapy |
| Waiting list | Active comparator | The waiting list group receives only multivitamin pills while being waiting and will receive the same intervention 3 months later Receives: Behavioral: BF-CBT and group physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of depression symptom from baseline at 3 and 6 months
Measured: 0-3-6 months
Change of anxiety symptom from baseline at 3 and 6 months
Measured: 0-3-6 months
Change of chronic pain symptom from baseline at 3 and 6 months
Measured: 0-3-6 months
Change of anger from baseline at 3 and 6 months
Measured: 0-3-6 months
Change of PTSD symptom from baseline at 3 and 6 months
Measured: 0-3-6 months
Secondary outcomes (5)
Change of disability scale from baseline at 3 and 6 months
Measured: 0-3-6 months
Change of hand-grip strength from baseline at 3 and 6 months
Measured: 0-3-6 months
Change of standing balance from baseline at 3 and 6 months
Measured: 0-3-6 months
Change of BMI from baseline at 3 and 6 months
Measured: 0-3-6 months
Change of heart rate variability from baseline at 3 and 6 months
Measured: 0-3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehabilitation and Research Centre for Torture Victims
- Sponsor type
- University, hospital or other
- Collaborators
- Kosova Rehabilitation Centre for Torture Victims
- Responsible party
- Principal investigator, Shr-Jie Wang, Rehabilitation and Research Centre for Torture Victims
- Investigators
- Shr-Jie Wang, Ph.D., Principal investigator, Rehabilitation and Research Centre for Torture Victims
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696578
- Sponsor's protocol ID
- RCTF5S2P4D1
- Status last verified
- Apr 2014
- First submitted
- 25 Sep 2012
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
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 20509915Wang 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 20858274Wang 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 22846511Wang 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01696578
- Acronym / sponsor ID
- RCTF5S2P4D1
- Conditions
- PTSD, Depression, Anxiety, Chronic Pain, Anger
- Keywords
- PTSD, Depression, Anxiety, Chronic pain, Anger, Heart rate variability, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Rehabilitation and Research Centre for Torture VictimsUniversity, hospital or other
- Collaborators
- Kosova Rehabilitation Centre for Torture Victims
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BF-CBT and group physiotherapy | Experimental | Behavioral: BF-CBT and group physiotherapyMultivitamin+10 sessions of biofeedback supported cognitive behavioral therapy (BF-CBT) and 10 sessions of group physiotherapy |
| Waiting list | Active comparator | Behavioral: BF-CBT and group physiotherapyThe waiting list group receives only multivitamin pills while being waiting and will receive the same intervention 3 months later |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BF-CBT and group physiotherapyMultivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis | Behavioural | BF-CBT and group physiotherapy, Waiting list |
Primary outcome
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
5 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
- Background: PubMed 20509915Wang 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.
- Background: PubMed 20858274Wang 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.
- Background: PubMed 22846511Wang 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.
- Derived from this study: PubMed 28191034Wang 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.
Related trials for PTSD
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shr-Jie Wang, Ph.D. principal investigator
Rehabilitation and Research Centre for Torture Victims
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BF-CBT and group physiotherapy in people with PTSD and Depression, run by Rehabilitation and Research Centre for Torture Victims at 1 site in Kosovo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kosovo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of depression symptom from baseline at 3 and 6 months (time frame: 0-3-6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01696578, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.