Completed

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

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What is being tested

BF-CBT and group physiotherapy

+ BF-CBT and group physiotherapy

Behavioral
Who is being recruted

Trauma and Stressor Related Disorders+10

+ Behavior

+ Mental Disorders

From 18 to 65 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2012
See protocol details

Summary

Principal SponsorRehabilitation and Research Centre for Torture Victims
Last updated: April 24, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorRehabilitation and Research Centre for Torture Victims
Last updated: April 24, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

31 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Trauma and Stressor Related DisordersBehaviorMental DisordersBehavioral SymptomsNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsStress Disorders, TraumaticAnxiety DisordersDepressionStress Disorders, Post-TraumaticChronic Pain

Criteria

2 inclusion criteria required to participate
Clinical diagnosis of PTSD and one of following symptoms: depression, anxiety or chronic pain

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

5 exclusion criteria prevent from participating
Having had any CBT in the past three years

Having recently undergone chemotherapy or chemo-radiotherapy for cancer or will have these therapy within following 6 months

With major alcoholic or substance abuse problems

With mental retardation or significant speech or cognitive impairment that would impede assessments

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Kosova Rehabilitation Centre for Torture Victims

Pristina, KosovoOpen Kosova Rehabilitation Centre for Torture Victims in Google Maps
CompletedOne Study Center