Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake

NCT01624935 | Completed DMC

• 1 other identifier: 10-02408
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder; Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Standard Clinical Interview for DSM IV Diagnosis (SCID)

  baseline through week 24

Study Arms (2)

psychotherapy

EXPERIMENTAL

psychotherapy

Behavioral: interpersonal psychotherapy

treatment as usual

OTHER

TAU control

Behavioral: interpersonal psychotherapy

Interventions

interpersonal psychotherapy BEHAVIORAL

interpersonal psychotherapy

psychotherapy; treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Wuhan Hospital for Psychotherapy

Fangting, Sichuan, China

Location

Related Publications (1)

• 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.

  PMID: 25254070 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Susan Meffert, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: June 21, 2012
• Study Start: July 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

CN (1)