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

This study has been completed.
Sponsor:
Collaborators:
Heartland Alliance
Ministry of Health of Iraq
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
William Weiss, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01177072
First received: July 16, 2010
Last updated: May 1, 2013
Last verified: May 2013

July 16, 2010
May 1, 2013
March 2011
July 2012   (final data collection date for primary outcome 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. [ Time Frame: After 12 counseling , 4-5 months ] [ Designated as safety issue: No ]
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.
Severity of Depression. 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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01177072 on ClinicalTrials.gov Archive Site
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). [ Time Frame: After 12 counseling session, estimated 4-5 months. ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Study of Effectiveness of Mental Health Interventions Among Torture Survivors in Southern Iraq
Study of Effectiveness of Mental Health Interventions Among Torture Survivors in Southern Iraq
  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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Anxiety
  • Post-Traumatic Stress Disorder
  • 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.
  • Other: Components-Based Intervention
    This is a 'components-based' intervention include psychoeducation, relaxation, life-enhancing skills (problems solving and safety planning), exposure, and cognitive processing of life problems and traumatic events. The duration of sessions are approximately one hour), the expected frequency of treatment is weekly, and recommended number of sessions are 12.
  • Experimental: 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: Other: Components-Based Intervention
  • Experimental: 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: Other: Cognitive Processing Therapy
  • No Intervention: 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
342
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Exposure to Torture
  • PTSD

Exclusion Criteria:

  • Children
  • Mentally incompetent to understand therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Iraq
 
NCT01177072
JHSPH-3034
No
William Weiss, Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
  • Heartland Alliance
  • Ministry of Health of Iraq
  • United States Agency for International Development (USAID)
Principal Investigator: William M Weiss, DrPH Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP