Controlled Trial of Mental Health Interventions for Torture Survivors in Kurdistan

May 1, 2013 updated by: Paul Bolton, Johns Hopkins Bloomberg School of Public Health

A Controlled Trial of Mental Health Interventions for Common Mental Health Problems Experienced by Torture Survivors Living in Kurdistan, Iraq.

The purpose of this study is to determine the relative effectiveness of three different mental health counseling interventions in the treatment of mental health problems commonly affecting torture and trauma survivors living in Kurdistan, Iraq.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See above

Study Type

Interventional

Enrollment (Actual)

530

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • ALL
      • Dohuk, Sulaimani, Erbil, rural areas, ALL, Iraq
        • multiple public health clinics across Kurdistan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • at least 18 years old
  • Kurdish
  • torture survivor
  • currently has significant depression symptomatology.

Exclusion Criteria:

  • danger to self or others
  • already receiving treatment from our treatment provider
  • not mentally competent to provide informed consent.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Processing Therapy
An adaptation of cognitive behavioral therapy, focusing on treatment for persons suffering mental health effects of trauma
Behavioral: Cognitive Processing Therapy
an adaptation of cognitive behavioral therapy used to address mental health effects of trauma exposure
Other Names:
  • CPT
Experimental: Behavioral Activation
A form of counseling therapy that emphasizes enhancing pleasurable behaviors and minimizing negative behaviors as a means to reducing depression symptomatology.
Behavioral: Behavioral Activation
form of counseling intervention to promote positive behaviors and reduce negative behaviors as a means of reducing depression symptomatology and severity
Other Names:
  • BA
Experimental: non-specific counseling
a collection of counseling skills suitable for a broad range of mental health and psychosocial problems and not designed for specific disorders. This particular version was developed by a collaborator -Heartland Alliance - for use with torture survivors.
Behavioral: nonspecific counseling
nonspecific counseling interventions useful for a broad range of mental health and psychosocial problems.
No Intervention: wait control
persons in this study arm will not receive active treatment as part of the study but will be monitored during the study and offered treatment after 3-5 months of waiting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
depression symptom severity
Time Frame: 3-6 months
3-6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
ability to carry out routine tasks and activities
Time Frame: 3-6 months
3-6 months
anxiety symptom severity
Time Frame: 3-6 months
3-6 months
posttraumatic stress disorder symptom severity
Time Frame: 3-6 months
3-6 months
traumatic grief symptom severity
Time Frame: 3-6 months
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Investigators

  • Principal Investigator: Paul A Bolton, MB BS, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 3, 2009

First Submitted That Met QC Criteria

June 19, 2009

First Posted (Estimate)

June 22, 2009

Study Record Updates

Last Update Posted (Estimate)

May 3, 2013

Last Update Submitted That Met QC Criteria

May 1, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BoltonP-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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