Post-Traumatic Stress DisorderTITANNCT04304378
Trauma Informed Treatment Algorithms for Novel Outcomes
A study testing Stabilization Techniques (ST), Stabilization Techniques with Behavioral Activation (ST+BA) and Eye Movement Desensitization and Reprocessing (EMDR) in people with Post-Traumatic Stress Disorder, run by University of Missouri, St. Louis at 2 sites in Cambodia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Stabilization Techniques (ST), Stabilization Techniques with Behavioral Activation (ST+BA) and Eye Movement Desensitization and Reprocessing (EMDR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 2 sitesCambodia
- Study dates
- 5 Oct 2020to 6 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Cambodia2 sites
Center for Trauma Care and Research Organization
Phnom Penh
EMDR Association Office
Phnom Penh
About this study
Official title: Enhancing Capacity for Mental Health Research and Care in Cambodia: Trauma Informed Treatment Algorithms for Novel Outcomes
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.
Read the 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.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Stabilization Techniques (ST), Stabilization Techniques with Behavioral Activation (ST+BA), Eye Movement Desensitization and Reprocessing (EMDR)
- Keywords
- Randomized controlled trial, Post-traumatic stress disorder, Global health, Mental disorders
- Medical subject headings
- Stress Disorders, Post-Traumatic, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilization Techniques (ST)Behavioural
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)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Stabilization Techniques with Behavioral Activation (ST+BA); Behavioral: Eye Movement Desensitization and Reprocessing (EMDR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of study participants who no longer screen positive for PTSD at four months using the PCL-5 questionnaire.
Measured: 4 months
Secondary outcomes (3)
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.
Measured: 4 months
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+).
Measured: 4 months
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).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start5 Oct 2020
- Primary completion6 Mar 2024
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, St. Louis
- Sponsor type
- University, hospital or other
- Collaborators
- NCHADS - Ministry of Health of Cambodia, Royal University of Phnom Penh, Florida International University, Center for Trauma and Research Organization (CTRO Cambodia), National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Robert Paul, University of Missouri, St. Louis
- Investigators
- Robert Paul, Ph.D., Principal investigator, University of Missouri, St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304378
- Sponsor's protocol ID
- R01MH114722
- Other IDs
- R01MH114722
- Acronym
- TITAN
- Status last verified
- Dec 2024
- First submitted
- 9 Mar 2020
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36865179
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Capacity for Mental Health Research and Care in Cambodia: Trauma Informed Treatment Algorithms for Novel Outcomes
- ClinicalTrials.gov ID
- NCT04304378
- Acronym / sponsor ID
- TITAN / R01MH114722
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Randomized controlled trial, Post-traumatic stress disorder, Global health, Mental disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- University of Missouri, St. LouisUniversity, hospital or other
- Collaborators
- NCHADS - Ministry of Health of Cambodia, Royal University of Phnom Penh, Florida International University, Center for Trauma and Research Organization (CTRO Cambodia), National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stabilization Techniques (ST) | Active comparator | Behavioral: Stabilization Techniques (ST), Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)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. |
| Stabilization Techniques with Behavioral Activation (ST+BA) | Experimental | Behavioral: Stabilization Techniques with Behavioral Activation (ST+BA), Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
- Use of psychiatric medications will be allowed but our preliminary work revealed fewer than 5% of all individuals receive medications for PTSD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Stabilization Techniques (ST) |
| 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. | Behavioural | Stabilization Techniques with Behavioral Activation (ST+BA) |
| 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. | Behavioural | Stabilization Techniques (ST), Stabilization Techniques with Behavioral Activation (ST+BA) |
Primary outcome
Percent of study participants who no longer screen positive for PTSD at four months using the PCL-5 questionnaire.
Time frame: 4 months
3 secondary outcomes
Culturally-Relevant PTSD Symptoms
Time frame: 4 months
Psychological Distress
Time frame: 4 months
Alcohol and Substance Use
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Derived from this study: PubMed 36865179Bertram 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Paul, Ph.D. principal investigator
University of Missouri, St. Louis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stabilization Techniques (ST), Stabilization Techniques with Behavioral Activation (ST+BA) and Eye Movement Desensitization and Reprocessing (EMDR) in people with Post-Traumatic Stress Disorder, run by University of Missouri, St. Louis at 2 sites in Cambodia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of study participants who no longer screen positive for PTSD at four months using the PCL-5 questionnaire. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04304378, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.