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Controlled Trial of Mental Health Interventions for Torture Survivors in Kurdistan

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ClinicalTrials.gov Identifier: NCT00925262
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : May 3, 2013
Sponsor:
Information provided by (Responsible Party):
Paul Bolton, Johns Hopkins Bloomberg School of Public Health

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Cognitive Processing Therapy Behavioral: Behavioral Activation Behavioral: nonspecific counseling Not Applicable

Detailed Description:
See above

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : June 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health
U.S. FDA Resources

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 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.



Primary Outcome Measures :
  1. depression symptom severity [ Time Frame: 3-6 months ]

Secondary Outcome Measures :
  1. ability to carry out routine tasks and activities [ Time Frame: 3-6 months ]
  2. anxiety symptom severity [ Time Frame: 3-6 months ]
  3. posttraumatic stress disorder symptom severity [ Time Frame: 3-6 months ]
  4. traumatic grief symptom severity [ Time Frame: 3-6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: May 2013

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