Controlled Trial of Mental Health Interventions for Torture Survivors in Kurdistan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paul Bolton, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00925262
First received: June 3, 2009
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Depression
Behavioral: Cognitive Processing Therapy
Behavioral: Behavioral Activation
Behavioral: nonspecific counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Controlled Trial of Mental Health Interventions for Common Mental Health Problems Experienced by Torture Survivors Living in Kurdistan, Iraq.

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • depression symptom severity [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ability to carry out routine tasks and activities [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
  • anxiety symptom severity [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
  • posttraumatic stress disorder symptom severity [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
  • traumatic grief symptom severity [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Enrollment: 530
Study Start Date: June 2009
Study Completion Date: October 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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.

Detailed Description:

See above

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925262

Locations
Iraq
multiple public health clinics across Kurdistan
Dohuk, Sulaimani, Erbil, rural areas, ALL, Iraq
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: Paul A Bolton, MB BS Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided

Responsible Party: Paul Bolton, Associate Scientist, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00925262     History of Changes
Other Study ID Numbers: BoltonP-1
Study First Received: June 3, 2009
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
mental health
randomized controlled trial
torture

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 30, 2014