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NCT Number: NCT01624935

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuhan Hospital for Psychotherapy

Fangting, Sichuan, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interpersonal psychotherapy

Behavioral

interpersonal psychotherapy

Primary outcomes

  1. Clinician Administered PTSD Scale (CAPS)

    Time frame: baseline through week 24

    CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24

Secondary outcomes

  1. Standard Clinical Interview for DSM IV Diagnosis (SCID)

    Time frame: baseline through week 24

    CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 21, 2012
Registry last updated
Oct 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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