NCT00925262

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
530

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2009

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 22, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

May 3, 2013

Status Verified

May 1, 2013

Enrollment Period

8 months

First QC Date

June 3, 2009

Last Update Submit

May 1, 2013

Conditions

Depression

Keywords

mental healthrandomized controlled trialtorture

Outcome Measures

Primary Outcomes (1)

  • depression symptom severity

    3-6 months

Secondary Outcomes (4)

  • ability to carry out routine tasks and activities

    3-6 months

  • anxiety symptom severity

    3-6 months

  • posttraumatic stress disorder symptom severity

    3-6 months

  • traumatic grief symptom severity

    3-6 months

Study Arms (4)

Cognitive Processing Therapy

EXPERIMENTAL

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

Behavioral: Cognitive Processing Therapy

Behavioral Activation

EXPERIMENTAL

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

Behavioral: Behavioral Activation

non-specific counseling

EXPERIMENTAL

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

wait control

NO INTERVENTION

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.

Interventions

Cognitive Processing TherapyBEHAVIORAL

an adaptation of cognitive behavioral therapy used to address mental health effects of trauma exposure

Also known as: CPT
Cognitive Processing Therapy
Behavioral ActivationBEHAVIORAL

form of counseling intervention to promote positive behaviors and reduce negative behaviors as a means of reducing depression symptomatology and severity

Also known as: BA
Behavioral Activation
nonspecific counselingBEHAVIORAL

nonspecific counseling interventions useful for a broad range of mental health and psychosocial problems.

non-specific counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

multiple public health clinics across Kurdistan

Dohuk, Sulaimani, Erbil, Rural Areas, ALL, Iraq

Location

Related Publications (1)

  • 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.

    PMID: 25551436DERIVED

MeSH Terms

Conditions

DepressionPsychological Well-Being

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Paul A Bolton, MB BS

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Scientist

Study Record Dates

First Submitted

June 3, 2009

First Posted

June 22, 2009

Study Start

June 1, 2009

Primary Completion

February 1, 2010

Study Completion

October 1, 2011

Last Updated

May 3, 2013

Record last verified: 2013-05

Locations

IR(1)