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Clinical Trials/NCT01177072
NCT01177072
Completed
N/A

Study of Effectiveness of Mental Health Interventions Among Torture Survivors in Southern Iraq

Johns Hopkins Bloomberg School of Public Health1 site in 1 country342 target enrollmentMarch 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
Johns Hopkins Bloomberg School of Public Health
Enrollment
342
Locations
1
Primary Endpoint
Severity of Trauma. This will be the difference in group mean score of severity of depression based on a sum of ratings of various standard depression symptoms from the Hopkins Symptom Checklist and locally defined symptoms.
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

  1. That the psychotherapeutic intervention - Components-Base Interventions (CBI) - is effective in reducing the severity of mental health symptoms experienced by torture survivors in Southern Iraq.
  2. That the psychotherapeutic intervention - Cognitive Processing Therapy (CPT) - is effective in reducing the severity of mental health symptoms experienced by torture survivors in Southern Iraq.

Detailed Description

For each intervention, participants will undergo 12 sessions (CBI or CPT) that are standardized by training and manual for community mental health workers (CHMWs). CMHWs will be trained in only one intervention. Prior to the starting sessions, a baseline assessment of depression, anxiety and trauma symptoms and function will be carried out. A follow up assessment will be carried out after the 12 sessions have been completed. Expected time between sessions is one week. The total time per client is expected to last about 4-5 months to complete the 12 therapy sessions. Participants will be randomized (within CMHW) to either immediate intervention or wait-list control. Participants that are wait-list control will be contacted monthly for assessment of condition. Any participant (intervention or control) with suicidal thoughts or distress that does not abate will be referred for psychiatric care.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
July 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

William Weiss

Assistant Scientist

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

Inclusion Criteria

  • Exposure to Torture

Exclusion Criteria

  • Mentally incompetent to understand therapy

Outcomes

Primary Outcomes

Severity of Trauma. This will be the difference in group mean score of severity of depression based on a sum of ratings of various standard depression symptoms from the Hopkins Symptom Checklist and locally defined symptoms.

Time Frame: After 12 counseling , 4-5 months

Although each counseling session is designed to be carried out one week apart for a total of 12 weeks, there are many reasons why a session will be missed. Our estimation is that a single client will require 4-5 months to complete the therapy.

Secondary Outcomes

  • Ability to Function. This is the difference in group mean of ability to function based on the sum of ratings of functional ability among various tasks identified by the local population as important functions (men and women have separate tasks).(After 12 counseling session, estimated 4-5 months.)

Study Sites (1)

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