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Trial of Mental Health Treatment for Darfur Refugees in Cairo

This study has been completed.
Sponsor:
Collaborator:
Ma'an Organization, Cairo, Egypt
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00879853
First received: April 9, 2009
Last updated: April 10, 2009
Last verified: April 2009
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879853

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

No publications provided

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
Study First Received: April 9, 2009
Last Updated: April 10, 2009
Health Authority: United States: Institutional Review Board

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
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
 Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on May 16, 2013