Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: interpersonal psychotherapy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Shifang, Sichuan, China
      • Wuhan Hospital for Psychotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: psychotherapy	Behavioral: interpersonal psychotherapy; interpersonal psychotherapy
Other: treatment as usual; TAU control	Behavioral: interpersonal psychotherapy; interpersonal psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Susan Meffert, MD, MPH, University of California, San Francisco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: February 7, 2012
• First Submitted That Met QC Criteria: June 20, 2012
• First Posted (Estimate): June 21, 2012

Study Record Updates

• Last Update Posted (Estimate): October 1, 2013
• Last Update Submitted That Met QC Criteria: September 30, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: PTSD; depression; global mental health; disaster; earthquake; disaster mental health
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Depression; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 10-02408