Study of Effectiveness of Mental Health Interventions Among Torture Survivors in Southern Iraq
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 342
- Locations
- 2
- 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.
Study Overview
Brief Summary
- 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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Exposure to Torture
Exclusion Criteria
- •Mentally incompetent to understand therapy
Arms & Interventions
Components-Based Interventions (CBI)
12 sessions of cognitive processing therapy. Sessions are expected to be approximately one week apart. 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.
Intervention: Components-Based Intervention (Other)
Cognitive Processing Therapy
12 sessions of cognitive processing therapy. Sessions are expected to be approximately one week apart. 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.
Intervention: Cognitive Processing Therapy (Other)
Wait List Control
Eligible clients will not be provided therapy at enrollment. After the study period has completed, control clients will be re-interviewed. Those that remain eligible due to symptom cutoff scores will be offered therapy. In the interim, controls will receive a phone call once a month; those with indications of possible harm to self or others will be referred to a psychiatrist.
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.)
Investigators
William Weiss
Assistant Scientist
Johns Hopkins Bloomberg School of Public Health