Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder; Depression
• Interventions: Behavioral: interpersonal psychotherapy

• Registration Number: NCT01624935
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-02-07
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-21
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-30
• Last Update Posted: 2013-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
psychotherapy	interpersonal psychotherapy	psychotherapy
treatment as usual	interpersonal psychotherapy	TAU control

Primary Outcome Measures

Name	Time	Method
Clinician Administered PTSD Scale (CAPS)	baseline through week 24	CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24

Secondary Outcome Measures

Name	Time	Method
Standard Clinical Interview for DSM IV Diagnosis (SCID)	baseline through week 24	CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24

Trial Locations

Locations (1)

Wuhan Hospital for Psychotherapy; 🇨🇳 Shifang, Sichuan, China