Trauma Informed Treatment Algorithms for Novel Outcomes

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

Interventions

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).

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• NCHADS - Ministry of Health of Cambodia

  collaborator OTHER

• Royal University of Phnom Penh

  collaborator UNKNOWN

• Florida International University

  collaborator OTHER

• Center for Trauma and Research Organization (CTRO Cambodia)

  collaborator UNKNOWN

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Missouri, St. Louis

  lead OTHER

Principal Investigators

• Robert Paul, Ph.D. · University of Missouri, St. Louis

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-05

Primary Completion

2024-03-06

Completion

2024-03-06

Countries

• Cambodia

Study Locations