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

May 1, 2013 updated by: William Weiss, Johns Hopkins Bloomberg School of Public Health
  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

342

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Several cities in Iraq (Karbala, Basra, Najaf, etc.), Iraq
        • Ministry of Health Iraq

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Exposure to Torture
  • PTSD

Exclusion Criteria:

  • Children
  • Mentally incompetent to understand therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After 12 counseling , 4-5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
After 12 counseling session, estimated 4-5 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

United States Agency for International Development (USAID)
Ministry of Health, Iraq
Heartland Alliance

Investigators

  • Principal Investigator: William M Weiss, DrPH, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 16, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (Estimate)

August 6, 2010

Study Record Updates

Last Update Posted (Estimate)

May 3, 2013

Last Update Submitted That Met QC Criteria

May 1, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHSPH-3034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Components-Based Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe