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Controlled Trial of Mental Health Interventions for Torture Survivors in Kurdistan

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Cognitive Processing Therapy
Behavioral Activation
nonspecific counseling
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring mental health, randomized controlled trial, torture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • multiple public health clinics across Kurdistan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Cognitive Processing Therapy

Behavioral Activation

non-specific counseling

wait control

Arm Description

An adaptation of cognitive behavioral therapy, focusing on treatment for persons suffering mental health effects of trauma

A form of counseling therapy that emphasizes enhancing pleasurable behaviors and minimizing negative behaviors as a means to reducing depression symptomatology.

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.

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.

Outcomes

Primary Outcome Measures

depression symptom severity

Secondary Outcome Measures

ability to carry out routine tasks and activities
anxiety symptom severity
posttraumatic stress disorder symptom severity
traumatic grief symptom severity

Full Information

First Posted
June 3, 2009
Last Updated
May 1, 2013
Sponsor
Johns Hopkins Bloomberg School of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT00925262
Brief Title
Controlled Trial of Mental Health Interventions for Torture Survivors in Kurdistan
Official Title
A Controlled Trial of Mental Health Interventions for Common Mental Health Problems Experienced by Torture Survivors Living in Kurdistan, Iraq.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
See above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
mental health, randomized controlled trial, torture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
530 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Processing Therapy
Arm Type
Experimental
Arm Description
An adaptation of cognitive behavioral therapy, focusing on treatment for persons suffering mental health effects of trauma
Arm Title
Behavioral Activation
Arm Type
Experimental
Arm Description
A form of counseling therapy that emphasizes enhancing pleasurable behaviors and minimizing negative behaviors as a means to reducing depression symptomatology.
Arm Title
non-specific counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
wait control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy
Other Intervention Name(s)
CPT
Intervention Description
an adaptation of cognitive behavioral therapy used to address mental health effects of trauma exposure
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation
Other Intervention Name(s)
BA
Intervention Description
form of counseling intervention to promote positive behaviors and reduce negative behaviors as a means of reducing depression symptomatology and severity
Intervention Type
Behavioral
Intervention Name(s)
nonspecific counseling
Intervention Description
nonspecific counseling interventions useful for a broad range of mental health and psychosocial problems.
Primary Outcome Measure Information:
Title
depression symptom severity
Time Frame
3-6 months
Secondary Outcome Measure Information:
Title
ability to carry out routine tasks and activities
Time Frame
3-6 months
Title
anxiety symptom severity
Time Frame
3-6 months
Title
posttraumatic stress disorder symptom severity
Time Frame
3-6 months
Title
traumatic grief symptom severity
Time Frame
3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Bolton, MB BS
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
multiple public health clinics across Kurdistan
City
Dohuk, Sulaimani, Erbil, rural areas
State/Province
ALL
Country
Iraq

12. IPD Sharing Statement

Citations:
PubMed Identifier
25551436
Citation
Bolton P, Bass JK, Zangana GA, Kamal T, Murray SM, Kaysen D, Lejuez CW, Lindgren K, Pagoto S, Murray LK, Van Wyk SS, Ahmed AM, Amin NM, Rosenblum M. A randomized controlled trial of mental health interventions for survivors of systematic violence in Kurdistan, Northern Iraq. BMC Psychiatry. 2014 Dec 31;14:360. doi: 10.1186/s12888-014-0360-2.
Results Reference
derived

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Controlled Trial of Mental Health Interventions for Torture Survivors in Kurdistan

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