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Trauma Informed Treatment Algorithms for Novel Outcomes (TITAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04304378
Recruitment Status : Unknown
Verified November 2020 by Robert Paul, University of Missouri, St. Louis.
Recruitment status was:  Recruiting
First Posted : March 11, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
University of Miami
Missouri Institute of Mental Health
NCHADS - Ministry of Health of Cambodia
Royal University of Phnom Penh
Mekong Project III
Information provided by (Responsible Party):
Robert Paul, University of Missouri, St. Louis

Tracking Information
First Submitted Date  ICMJE March 9, 2020
First Posted Date  ICMJE March 11, 2020
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE October 5, 2020
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
Percent of study participants who no longer screen positive for PTSD at four months using the PCL-5 questionnaire. [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2020)
  • Culturally-Relevant PTSD Symptoms [ Time Frame: 4 months ]
    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.
  • Psychological Distress [ Time Frame: 4 months ]
    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+).
  • Alcohol and Substance Use [ Time Frame: 4 months ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
  • Culturally-Relevant PTSD Symptoms [ Time Frame: 4 months ]
    The Cambodian Symptom and Syndrome Inventory (CSSI) is a culturally validated measure of PTSD symptoms that yields a mean composite score.
  • Psychological Distress [ Time Frame: 4 months ]
    The Depression, Anxiety and Stress Scale (DASS-21) is a validated measure of psychological distress that yields a mean composite score.
  • Alcohol and Substance Use [ Time Frame: 4 months ]
    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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trauma Informed Treatment Algorithms for Novel Outcomes
Official Title  ICMJE Enhancing Capacity for Mental Health Research and Care in Cambodia: Trauma Informed Treatment Algorithms for Novel Outcomes
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Post-Traumatic Stress Disorder
Intervention  ICMJE
  • 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 Mekong Project 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.
Study Arms  ICMJE
  • Active Comparator: Stabilization Techniques (ST)

    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.

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

    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.

    Interventions:
    • Behavioral: Stabilization Techniques with Behavioral Activation (ST+BA)
    • Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 10, 2020)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cambodia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04304378
Other Study ID Numbers  ICMJE R01MH114722( U.S. NIH Grant/Contract )
R01MH114722 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Robert Paul, University of Missouri, St. Louis
Original Responsible Party Robert Paul, University of Missouri, St. Louis, Robert Paul, Ph.D., ABCN
Current Study Sponsor  ICMJE University of Missouri, St. Louis
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute of Mental Health (NIMH)
  • University of Miami
  • Missouri Institute of Mental Health
  • NCHADS - Ministry of Health of Cambodia
  • Royal University of Phnom Penh
  • Mekong Project III
Investigators  ICMJE
Principal Investigator: Robert Paul, Ph.D. University of Missouri, St. Louis
PRS Account University of Missouri, St. Louis
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP