Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake

NCT ID: NCT01624935

Last Updated: 2013-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-04-30

Brief Summary

The enormous global burden of mental illness has been estimated through the publication of the Global Burden of Disease Study. Research confirms that populations exposed to mass trauma such as natural disaster bear a particularly high burden of mental disorders, with depression and Posttraumatic Stress Disorder (PTSD) generally being the top two adult psychiatric diagnoses. In traumatized populations, these disorders do not remit with replacement of material losses or resettlement to safe locations, but rather tend to become chronic conditions with attendant disability. 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. This "infectious" model of trauma/violence is critically important in the setting of natural disaster, as increased levels of interpersonal violence within the afflicted community hinder its recovery. To date, there has been little research on the interpersonal effects of mass trauma. The proposed research is a randomized controlled trial of "Interpersonal Therapy" (IPT) versus wait list control (WLC) for survivors of the Sichuan Earthquake living in Shifang, China. IPT, a very effective therapy for depression, has been adapted for PTSD treatment and developing country settings. Measures will evaluate success of the treatment not only in terms of individual depression and PTSD symptoms, but also with respect to interpersonal functioning.

Hypothesis 1: Relative to wait list control, fewer subjects who received IPT will meet criteria for Depression and PTSD at the conclusion of the RCT.

Hypothesis 2: Subjects who received IPT will have greater improvement of social functioning than wait list controls.

Detailed Description

Interpersonal Psychotherapy adapted for local mental health care needs was applied using wait list control design.

Conditions

Posttraumatic Stress Disorder; Depression

Keywords

PTSD; earthquake; disaster; global mental health; disaster mental health; depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

psychotherapy

psychotherapy

Group Type: EXPERIMENTAL

interpersonal psychotherapy

Intervention Type: BEHAVIORAL

interpersonal psychotherapy

treatment as usual

TAU control

Group Type: OTHER

interpersonal psychotherapy

Intervention Type: BEHAVIORAL

interpersonal psychotherapy

Interventions

interpersonal psychotherapy

interpersonal psychotherapy

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age greater than 18 years;
• diagnosis with Depressive Disorder and Posttraumatic Stress Disorder (PTSD);
• Ability to attend weekly therapy sessions for 12 weeks and return for post-treatment screening;
• Ability to give verbal informed consent

Exclusion Criteria

• 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 and alcohol dependence

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Meffert, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Wuhan Hospital for Psychotherapy

Fangting, Sichuan, China

Countries

China

References

Jiang RF, Tong HQ, Delucchi KL, Neylan TC, Shi Q, Meffert SM. Interpersonal psychotherapy versus treatment as usual for PTSD and depression among Sichuan earthquake survivors: a randomized clinical trial. Confl Health. 2014 Sep 4;8:14. doi: 10.1186/1752-1505-8-14. eCollection 2014.

Reference Type: DERIVED

PMID: 25254070 (View on PubMed)

Other Identifiers

10-02408

Identifier Type: -

Identifier Source: org_study_id