Trial of Mental Health Treatment for Darfur Refugees in Cairo

NCT ID: NCT00879853

Last Updated: 2023-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-Traumatic Stress Disorder Depression Anger Domestic Violence

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Interpersonal Therapy

Group Type EXPERIMENTAL

Interpersonal Therapy

Intervention Type BEHAVIORAL

Wait List Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Interpersonal Therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 .
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ma'an Organization

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of California, San Francisco

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ma'an Organization

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UCSF Academic Senate Grant

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.