Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT01624935

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder Depression	Behavioral: interpersonal psychotherapy	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: psychotherapy

psychotherapy

Behavioral: interpersonal psychotherapy

interpersonal psychotherapy

Other: treatment as usual

TAU control

Behavioral: interpersonal psychotherapy

interpersonal psychotherapy

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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