Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01624935
First received: February 7, 2012
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Posttraumatic Stress Disorder
Depression
Behavioral: interpersonal psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: baseline through week 24 ] [ Designated as safety issue: No ]
    CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24


Secondary Outcome Measures:
  • Standard Clinical Interview for DSM IV Diagnosis (SCID) [ Time Frame: baseline through week 24 ] [ Designated as safety issue: No ]
    CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24


Enrollment: 60
Study Start Date: July 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: psychotherapy
psychotherapy
Behavioral: interpersonal psychotherapy
interpersonal psychotherapy
treatment as usual
TAU control
Behavioral: interpersonal psychotherapy
interpersonal psychotherapy

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624935

Locations
China, Sichuan
Wuhan Hospital for Psychotherapy
Shifang, Sichuan, China
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Susan Meffert, MD, MPH University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01624935     History of Changes
Other Study ID Numbers: 10-02408
Study First Received: February 7, 2012
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
PTSD
earthquake
disaster
global mental health
disaster mental health
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on April 15, 2014