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Trial of Mental Health Treatment for Darfur Refugees in Cairo

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00879853
First Posted: April 13, 2009
Last Update Posted: April 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ma'an Organization, Cairo, Egypt
Information provided by:
University of California, San Francisco
  Purpose
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.

Condition Intervention
Post-Traumatic Stress Disorder Depression Anger Domestic Violence Behavioral: Interpersonal Therapy

Study Type: Interventional
Official Title: Randomized Controlled Trial of Mental Health Treatment for Darfur Refugees in Cairo

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Post-traumatic Stress Disorder Symptoms

Secondary Outcome Measures:
  • Depression Symptoms
  • Anger
  • Household Conflict/Violence

Arms Assigned Interventions
Experimental: Interpersonal Therapy Behavioral: Interpersonal Therapy
No Intervention: Wait List Control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age greater than 18 years;
  2. Absence of cognitive dysfunction which requires a higher level of care and/or interferes with ability to participate in IPT;
  3. Absence of severe thought or mood disorder symptoms which requires a higher level of care and/or interferes with ability to participate in IPT;
  4. Absence of drug and alcohol dependence;
  5. HTQ score of 2.3 or greater;
  6. Ability to attend twice a week therapy sessions for 4 weeks and return for regular screening;
  7. Ability to give verbal informed consent .

Exclusion Criteria:

  1. Unable to give informed consent;
  2. Age less than 18;
  3. Cognitive dysfunction which requires a higher level of care and/or interferes with ability to participate in IPT;
  4. Severe thought or mood disorder symptoms which requires a higher level of care and/or interferes with ability to participate in IPT;
  5. Drug or alcohol dependence in the past 6 months;
  6. HTQ score less than 2.5;
  7. Inability to attend twice a week therapy sessions for 4 weeks and return for regular screening .
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879853


Locations
Egypt
Ma'an Organization
Cairo, Egypt
Sponsors and Collaborators
University of California, San Francisco
Ma'an Organization, Cairo, Egypt
  More Information

Responsible Party: Charles Marmar, M.D., University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00879853     History of Changes
Other Study ID Numbers: UCSF Academic Senate Grant
First Submitted: April 9, 2009
First Posted: April 13, 2009
Last Update Posted: April 13, 2009
Last Verified: April 2009

Keywords provided by University of California, San Francisco:
PTSD
Depression
Anger
Domestic Violence
Refugee
Asylum Seeker
Community Therapist
Paraprofessional Therapists

Additional relevant MeSH terms:
Depression
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Trauma and Stressor Related Disorders
Mental Disorders