Trauma Informed Treatment Algorithms for Novel Outcomes

NCT04304378 | Completed DMC

• 1 other identifier: R01MH114722
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-Traumatic Stress Disorder

Keywords

Randomized controlled trial; Post-traumatic stress disorder; Global health; Mental disorders

Outcome Measures

Primary Outcomes (1)

• Percent of study participants who no longer screen positive for PTSD at four months using the PCL-5 questionnaire.

  4 months

Secondary Outcomes (3)

• Culturally-Relevant PTSD Symptoms

  4 months

• Psychological Distress

  4 months

• Alcohol and Substance Use

  4 months

Study Arms (2)

Stabilization Techniques (ST)

ACTIVE COMPARATOR

Participants randomized into ST will receive 6 weekly 1-hour sessions of Stabilization Techniques from a Khmer-speaking mental health professional. Sessions provide an opportunity to improve emotion regulation and provide coping skills for managing symptoms of PTSD. Participants will complete a follow-up assessment 2 months after randomization in which PTSD symptoms will be re-assessed using the PTSD Checklist (PCL-5) for the Diagnostic and Statistical Manual for Mental Disorders (DSM-5). Those who exhibit a 50% reduction in PTSD symptoms from baseline and no longer meet criteria for PTSD will be designated as responders and will receive no further treatment. Participants who continue to display clinically meaningful elevations in PTSD symptoms (i.e., non-responders) will receive EMDR, which is the standard of care for trauma treatment in Cambodia. EMDR sessions will be delivered by a Khmer-speaking mental health professional.

Behavioral: Stabilization Techniques (ST); Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)

Stabilization Techniques with Behavioral Activation (ST+BA)

EXPERIMENTAL

Participants randomized into ST+BA will receive 3 weekly 1-hour sessions of ST and 3 weekly 1-hour sessions of BA from a Khmer-speaking mental health professional. Sessions include stabilization techniques and behavioral skills that aim to establish and maintain routines, reduce avoidance, and manage negative emotions. Participants will complete a follow-up assessment 2 months after randomization in which PTSD symptoms will be re-assessed using the PTSD Checklist (PCL-5) for the Diagnostic and Statistical Manual for Mental Disorders (DSM-5). Those who exhibit a 50% reduction in PTSD symptoms from baseline and no longer meet criteria for PTSD will be designated as responders and will receive no further treatment. Participants who continue to display clinically meaningful elevations in PTSD symptoms (i.e., non-responders) will receive EMDR, which is the standard of care for trauma treatment in Cambodia. EMDR sessions will be delivered by a Khmer-speaking mental health professional.

Behavioral: Stabilization Techniques with Behavioral Activation (ST+BA); Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)

Interventions

Stabilization Techniques (ST) BEHAVIORAL

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 (ST)

Stabilization Techniques with Behavioral Activation (ST+BA) BEHAVIORAL

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.

Stabilization Techniques with Behavioral Activation (ST+BA)

Eye Movement Desensitization and Reprocessing (EMDR) BEHAVIORAL

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.

Stabilization Techniques (ST); Stabilization Techniques with Behavioral Activation (ST+BA)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri, St. Louis: lead
• NCHADS - Ministry of Health of Cambodia: collaborator
• Royal University of Phnom Penh: collaborator
• Florida International University: collaborator
• Center for Trauma and Research Organization (CTRO Cambodia): collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Center for Trauma Care and Research Organization

Phnom Penh, Cambodia

Location

EMDR Association Office

Phnom Penh, Cambodia

Location

Related Publications (1)

• Bertram JE, Kryah R, Vandermause R, Ean N, Paul R, Carrico A, Sophal C, Bruce S, Gregory K, Stein E, Mannarino J. "No matter what, we just work with the trauma...": Mental Health Therapists' Care of Diverse Sexual and Gender Identity Citizens in Cambodia. Res Sq [Preprint]. 2023 Feb 20:rs.3.rs-2584144. doi: 10.21203/rs.3.rs-2584144/v1.

  PMID: 36865179 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Mental Disorders

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Robert Paul, Ph.D.

  University of Missouri, St. Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Curators' Distinguished Professor

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 11, 2020
• Study Start: October 5, 2020
• Primary Completion: March 6, 2024
• Study Completion: March 6, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

CA (2)