- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00879853
Trial of Mental Health Treatment for Darfur Refugees in Cairo
November 6, 2023 updated by: University of California, San Francisco
Randomized Controlled Trial of Mental Health Treatment for Darfur Refugees in Cairo
The enormous global burden of mental illness has been estimated through the publication of the Global Burden of Disease Study, adding momentum to refugee mental health studies (1,2).
As research confirms that high levels of Posttraumatic Stress Disorder (PTSD) and depression occur in post-conflict settings, it is essential to develop effective treatment for psychological trauma in refugee populations recovering from mass violence (3-4).
PTSD and depression are risk factors for anger, interpersonal discord and violence, not only among those who have trauma and depression, but also among their spouses and children (5-9).
This "infectious" model of trauma/violence is critically important in the setting of ethnic conflict, as increased levels of interpersonal violence within the afflicted community hinder its recovery and fuel future cycles of conflict.
To date, there has been little research on the interpersonal effects of trauma among refugee populations.
The proposed research is a pilot and randomized controlled trial of "Interpersonal Therapy" (IPT) for Sudanese refugees living in Cairo.
IPT, a very effective therapy for depression, has been adapted for PTSD treatment and sub-Saharan Africa settings (10-12).
Measures will evaluate success of the treatment not only in terms of individual PTSD and depression symptoms, but also with respect to interpersonal conflict.
Hypotheses: (1) After IPT intervention, Sudanese refugees will have lower levels of depression and trauma symptoms compared to wait list controls (2) After IPT intervention, Sudanese refugees will have lower levels of interpersonal violence compared to wait list controls.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
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
-
-
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Cairo, Egypt
- Ma'an Organization
-
-
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
Yes
Description
Inclusion Criteria:
- Age greater than 18 years;
- Absence of cognitive dysfunction which requires a higher level of care and/or interferes with ability to participate in IPT;
- Absence of severe thought or mood disorder symptoms which requires a higher level of care and/or interferes with ability to participate in IPT;
- Absence of drug and alcohol dependence;
- HTQ score of 2.3 or greater;
- Ability to attend twice a week therapy sessions for 4 weeks and return for regular screening;
- Ability to give verbal informed consent .
Exclusion Criteria:
- Unable to give informed consent;
- Age less than 18;
- Cognitive dysfunction which requires a higher level of care and/or interferes with ability to participate in IPT;
- Severe thought or mood disorder symptoms which requires a higher level of care and/or interferes with ability to participate in IPT;
- Drug or alcohol dependence in the past 6 months;
- HTQ score less than 2.5;
- Inability to attend twice a week therapy sessions for 4 weeks and return for regular screening .
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?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Wait List Control
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Experimental: Interpersonal Therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Post-traumatic Stress Disorder Symptoms
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Secondary Outcome Measures
Outcome Measure |
|---|
|
Depression Symptoms
|
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Anger
|
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Household Conflict/Violence
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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 Registration Dates
First Submitted
April 9, 2009
First Submitted That Met QC Criteria
April 10, 2009
First Posted (Estimated)
April 13, 2009
Study Record Updates
Last Update Posted (Actual)
November 8, 2023
Last Update Submitted That Met QC Criteria
November 6, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCSF Academic Senate Grant
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.
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