Clinical trial NCT04304378: Trauma Informed Treatment Algorithms for Novel Outcomes
Official title: Enhancing Capacity for Mental Health Research and Care in Cambodia: Trauma Informed Treatment Algorithms for Novel Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Keywords: Randomized controlled trial
Post-traumatic stress disorder
Global health
Mental disorders
Lead sponsor: University of Missouri, St. Louis
Sponsor class: OTHER
Collaborators: name: NCHADS - Ministry of Health of Cambodia
name: Royal University of Phnom Penh
name: Florida International University
name: Center for Trauma and Research Organization (CTRO Cambodia)
name: National Institutes of Health (NIH)
name: National Institute of Mental Health (NIMH)
First posted: 2020-03-11
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial (RCT) will examine the feasibility, acceptability, and preliminary efficacy of a beginning treatment for Post-Traumatic Stress Disorder (PTSD) with Behavioral Activation (BA). Cambodian men and women who screen positive for PTSD will be randomized to receive six individually delivered sessions of either: 1) Stabilization Techniques alone (ST); or 2) ST+BA. After two months, all participants who continue to report clinically meaningful elevations in PTSD will receive Eye Movement Desensitization Reprocessing (EMDR). All participants will complete a follow-up assessment at four months post-randomization.

Detailed description: Nearly half of the Cambodian population reports elevated levels of psychological distress and PTSD. The high levels of psychological distress are linked directly to the report of remote and more recent trauma exposures, the most notable of which is the agrarian political regime of the Khmer Rouge during the 1970s, which occurred in the aftermath of the Vietnam War. During this period, approximately 1.5 million Cambodian residents died of starvation and sickness, 500,000 individuals were executed, and another two million were displaced over the course of several years. Political stability took shape in the early 1990s after the enactment of the United Nations Transitional Authority in Cambodia. However, the prior violence undermined an already fragile healthcare system, including mental health institutions and physicians providing direct patient care.

The combination of high trauma exposure, sustained conflict, and limited psychiatric capacity has created heightened vulnerability for Cambodians, and the need to assist those struggling with PTSD. There is a pressing need to reverse this trajectory using novel approaches to address mental health needs that are effective and scalable, providing a strong basis to conduct the proposed work in Cambodia. In partnership with the Cambodian Department of Mental Health and Substance Abuse, Ministry of Health, this NIH-sponsored study will examine the feasibility, acceptability, and preliminary efficacy integrating BA into trauma treatment that is being delivered by the Mekong Project in Cambodia.

Eligibility criteria: Inclusion Criteria:

* Trauma exposure and screens positive for PTSD as measured by the DSM-5 PTSD Checklist (PCL-5), a 20-item scale to measure severity of PTSD symptoms
* Able to communicate in Khmer
* Able to provide informed consent as defined by ability to accurately paraphrase the purpose

Exclusion Criteria:

* Active psychosis or developmental disorder that precludes an individual's ability to provide informed consent
* Severe alcohol or substance use disorder a determined by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)

Note:

* Use of psychiatric medications will be allowed but our preliminary work revealed fewer than 5% of all individuals receive medications for PTSD

Primary outcomes:
measure: Percent of study participants who no longer screen positive for PTSD at four months using the PCL-5 questionnaire.
timeFrame: 4 months
Secondary outcomes:
measure: Culturally-Relevant PTSD Symptoms
timeFrame: 4 months
measure: Psychological Distress
timeFrame: 4 months
measure: Alcohol and Substance Use
timeFrame: 4 months
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: Center for Trauma Care and Research Organization
city: Phnom Penh
country: Cambodia
facility: EMDR Association Office
Study officials:
affiliation: University of Missouri, St. Louis
name: Robert Paul, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: