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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
  Purpose
  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.

Condition Intervention
Depression
Anxiety
Post-Traumatic Stress Disorder
Other: Cognitive Processing Therapy
Other: Components-Based Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Effectiveness of Mental Health Interventions Among Torture Survivors in Southern Iraq

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 342
Study Start Date: March 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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: 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.
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Exposure to Torture
  • PTSD

Exclusion Criteria:

  • Children
  • Mentally incompetent to understand therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177072

Locations
Iraq
Ministry of Health Iraq
Several cities in Iraq (Karbala, Basra, Najaf, etc.), Iraq
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Heartland Alliance
Ministry of Health of Iraq
United States Agency for International Development (USAID)
Investigators
Principal Investigator: William M Weiss, DrPH Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided

Responsible Party: William Weiss, Assistant Scientist, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01177072     History of Changes
Other Study ID Numbers: JHSPH-3034
Study First Received: July 16, 2010
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board
Iraq: Ethics Committee

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
PTSD

Additional relevant MeSH terms:
Depression
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Behavioral Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on November 20, 2014