Trauma Informed Treatment Algorithms for Novel Outcomes

Post-Traumatic Stress Disorder Clinical Trial

— TITAN  

Official title:

Enhancing Capacity for Mental Health Research and Care in Cambodia: Trauma Informed Treatment Algorithms for Novel Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04304378
• Other study ID #: R01MH114722
• Secondary ID: R01MH114722
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: July 2023

Study information

• Verified date: March 2023
• Source: University of Missouri, St. Louis
• Contact: Robert Paul, Ph.D.
• Phone: (314) 516-8403
• Email: paulro[@]umsl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Stabilization Techniques (ST)
The Stabilization Techniques intervention provides an opportunity to improve emotion/affect regulation and coping skills. The overarching goal of these sessions is to introduce different ways of managing emotional distress through imagery and stress reduction techniques. ST sessions focus on providing coping mechanisms for managing important symptoms of PTSD (i.e., hyperarousal, negative emotions, and physical symptoms).
• Stabilization Techniques with Behavioral Activation (ST+BA)
The Stabilization Techniques with Behavioral Activation intervention includes stabilization techniques as well as sessions targeted at increasing time engaged in physical activities during times outside of the intervention session. Preferred activities are selected by the participant. Strategies to foster engagement in the selected activities will include self-monitoring, structuring and scheduling daily activities, rating the degree of pleasure and accomplishment experienced during engagement in specific daily activities, exploring alternative behaviors related to achieving goals, and using role-play to address specific barriers. Establishing/maintaining routines and behavioral strategies to reduce avoidance and mange negative emotions are emphasized.
• Eye Movement Desensitization and Reprocessing (EMDR)
EMDR is an exposure-based treatment that is the standard of care for PTSD delivered by the research team in Phnom Penh. EMDR utilizes sensory stimulation when participants are engaged in mental processing of traumatic material. EMDR follows a sequential framework targeting 1) past memories, 2) present symptoms, and 3) future actions.

Locations

Country	Name	City	State
Cambodia	Center for Trauma Care and Research Organization	Phnom Penh
Cambodia	EMDR Association Office	Phnom Penh

Sponsors (6)

Lead Sponsor	Collaborator
University of Missouri, St. Louis	National Institute of Mental Health (NIMH), National Institutes of Health (NIH), NCHADS - Ministry of Health of Cambodia, Royal University of Phnom Penh, University of Miami

Country where clinical trial is conducted

Cambodia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of study participants who no longer screen positive for PTSD at four months using the PCL-5 questionnaire.		4 months
Secondary	Culturally-Relevant PTSD Symptoms	The Cambodian Symptom and Syndrome Inventory (CSSI) is a culturally validated measure of PTSD symptoms that yields a total score ranging from 0-148, with higher scores indicative of greater symptomatology.	4 months
Secondary	Psychological Distress	The Depression, Anxiety and Stress Scale (DASS-21) is a validated measure of psychological distress that yields domain scores ranging from Normal (depression=0-4; anxiety=0-3; stress=0-7) to Extremely Severe (depression=14+; anxiety=10+; stress=17+).	4 months
Secondary	Alcohol and Substance Use	The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) provides validated composite scores indexing the severity of alcohol and other substance use (Mild = 0-3; Moderate = 4-26; Severe = 27 or greater).	4 months