Clinical trial NCT01177072: Study of Effectiveness of Mental Health Interventions Among Torture Survivors in Southern Iraq
Official title: Study of Effectiveness of Mental Health Interventions Among Torture Survivors in Southern Iraq
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Post-Traumatic Stress Disorder
Keywords: PTSD
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Heartland Alliance
name: Ministry of Health, Iraq
name: United States Agency for International Development (USAID)
First posted: 2010-08-06
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Exposure to Torture
* PTSD

Exclusion Criteria:

* Children
* Mentally incompetent to understand therapy

Primary outcomes:
measure: 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.
timeFrame: After 12 counseling , 4-5 months
Secondary outcomes:
measure: 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).
timeFrame: After 12 counseling session, estimated 4-5 months.
Other outcomes:
Locations:
city: Several cities in Iraq (Karbala, Basra, Najaf, etc.)
country: Iraq
facility: Ministry of Health Iraq
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: William M Weiss, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weiss WM, Murray LK, Zangana GA, Mahmooth Z, Kaysen D, Dorsey S, Lindgren K, Gross A, Murray SM, Bass JK, Bolton P. Community-based mental health treatments for survivors of torture and militant attacks in Southern Iraq: a randomized control trial. BMC Psychiatry. 2015 Oct 14;15:249. doi: 10.1186/s12888-015-0622-7.