Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake

Depression Clinical Trial

Official title:

Randomized Controlled Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624935
• Other study ID #: 10-02408
• Status: Completed
• Phase: N/A
• First received: February 7, 2012
• Last updated: September 30, 2013
• Start date: July 2011
• Est. completion date: April 2012

Study information

• Verified date: September 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• interpersonal psychotherapy
interpersonal psychotherapy

Locations

Country	Name	City	State
China	Wuhan Hospital for Psychotherapy	Shifang	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS)	CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24	baseline through week 24	No
Secondary	Standard Clinical Interview for DSM IV Diagnosis (SCID)	CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24	baseline through week 24	No