PtsdPhase 3NCT04856033
Transcendental Meditation and PTSD
A Phase 3 study testing TM and PCT in people with Ptsd and Depressive Symptoms, run by David Lynch Foundation.
Trial summary
This paper describes the rationale and design of a Phase 3 RCT comparing Transcendental Meditation to Present Centered Therapy for posttraumatic stress disorder (PTSD), suicidal ideation, alcohol use, and depressive symptoms in Veterans. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Ptsd, Depressive Symptoms, Suicidal Ideation
- What is being tested?
- TM and PCT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Dec 2023
- Phase
- Phase 3
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current diagnosis of PTSD from medical record or CAPS-5 interview
- A symptom severity score≥33 on the CAPS-5 indicating clinically significant PTSD symptoms
- Three or more months since trauma
- Agreement to not receive other psychotherapy or meditation for PTSD during the active treatment or follow-up period. Psychotherapy for other problems will be allowed.
- If being treated with psychoactive medications, a stable regimen (no change in drugs or dose) for at least 2 months before enrollment
- Age: 18 years or older
- Language: English literate
Who cannot join
- Prior training with TM or treatment with PCT in the past year
- Currently untreated psychotic symptoms or mania symptoms from chart review or self-report
- Moderate or greater cognitive impairment indicated by chart diagnosis or observable cognitive difficulties
- Acute severe symptoms (such as imminent suicidal risk) that will likely require active treatment intervention (such as medication changes) within the course of the study
- Psychiatric hospitalization in the previous six months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 3 Clinical Trial on Transcendental Meditation and Posttraumatic Stress Disorder, Suicide, and Substance Use in Veterans
This paper describes the rationale and design of a Phase 3 RCT comparing Transcendental Meditation to Present Centered Therapy for posttraumatic stress disorder (PTSD), suicidal ideation, alcohol use, and depressive symptoms in Veterans. In this multisite trial, 450 Veterans meeting Diagnostic and Statistical Manual-5 (DSM-5) criteria for PTSD will be recruited from nine VA and academic medical center sites across the U.S. Study outcomes include changes in PTSD diagnosis and symptom severity (primary), suicidal ideation, alcohol use, and depressive symptoms. Participation includes baseline testing and post-treatment assessments at 12, 24, and 36-weeks. During each assessment visit, Veterans will complete diagnostic interviews, including the Clinician-Administered PTSD Scale for DSM-5 and the Alcohol Timeline Followback, as well as validated self-report measures. Cost-effectiveness of the treatments will be measured using intervention and healthcare costs, the proportion with PTSD diagnosis removed, and Quality-Adjusted Life Years. Finally, single-site substudies will examine pre-to-post-treatment changes in PTSD biomarkers and on magnetic resonance imaging (MRI).
Read the detailed description
Background: The evidence supporting the Transcendental Meditation (TM) technique as a treatment for posttraumatic stress disorder (PTSD) has advanced considerably in the past decade. With a recent randomized controlled trial (RCT) suggesting statistical superiority to active control treatments for PTSD (e.g., Present Centered Therapy [PCT]) and noninferiority to first-line PTSD psychotherapies, additional research evaluating the benefits and cost-effectiveness of TM for PTSD among Veterans is needed.
Methods and design: This paper describes the rationale and design of a Phase 3 RCT comparing TM to PCT for PTSD in Veterans. In this multisite trial, 450 Veterans meeting DSM-5 criteria for PTSD will be recruited from nine VA and academic medical center sites across the U.S. Study outcomes include changes in PTSD diagnosis and symptom severity (primary), suicidal ideation, alcohol use, and depressive symptoms. Participation includes baseline testing and post-treatment assessments at 12, 24, and 36-weeks. During each assessment visit, Veterans will complete diagnostic interviews, including the Clinician-Administered PTSD Scale for DSM-5 and the Alcohol Timeline Followback, as well as validated self-report measures. Cost-effectiveness of the treatments will be measured using intervention and healthcare costs, the proportion with PTSD diagnosis removed, and Quality-Adjusted Life Years. Finally, single-site substudies will examine pre-to-post-treatment changes in PTSD biomarkers and on magnetic resonance imaging (MRI).
Discussion: Despite progress in PTSD treatments, new evidence-based treatments are still needed for Veterans who drop-out of or respond poorly to existing trauma-focused psychotherapies and that may assist Veterans with common PTSD-comorbidities such as depression, suicidal ideation, and substance use. This multisite trial seeks to advance the science and potential application of TM as a treatment for PTSD in Veterans.
- Conditions
- Ptsd, Depressive Symptoms, Suicidal Ideation, Alcohol Use, Unspecified
- Being tested
- TM, PCT
- Keywords
- Ptsd, Veterans, Meditation, Suicidal ideation, Randomized Controlled Trial
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Suicidal Ideation, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMBehavioural
Transcendental Meditation instruction, 12-sessions over 3-4 months with monthly follow-up
PCTBehavioural
Present Centered Therapy, 12-sessions over 3-4 months with monthly follow-up
| Study group | Role | What they receive |
|---|---|---|
| TM | Experimental | Transcendental Mediation Receives: Behavioral: TM |
| PCT | Active comparator | Present Centered Therapy Receives: Behavioral: PCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD diagnosis and symptoms
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) changes in PTSD diagnosis and symptom severity. Scores range from 0-80 with higher scores=higher PTSD symptoms
Measured: Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Secondary outcomes (3)
Depressive symptoms
Patient Health Questionnaire-9 (PHQ-9) changes, range=0-27, higher scores=higher depressive symptoms
Measured: Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Alcohol use
Timeline Followback changes
Measured: Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Suicidal ideation
Columbia-Suicide Severity Rating Scale (C-SSRS), range 0-25 with higher scores=greater suicidal ideation intensity
Measured: Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study startOct 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PtsdStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 group RCT
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Lynch Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Rutledge, PhD, Principal investigator, VA San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856033
- Sponsor's protocol ID
- DLF2021
- Status last verified
- Apr 2021
- First submitted
- 16 Apr 2021
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Clinical Trial on Transcendental Meditation and Posttraumatic Stress Disorder, Suicide, and Substance Use in Veterans
- ClinicalTrials.gov ID
- NCT04856033
- Acronym / sponsor ID
- DLF2021
- Conditions
- Ptsd, Depressive Symptoms, Suicidal Ideation, Alcohol Use, Unspecified
- Keywords
- Ptsd, Veterans, Meditation, Suicidal ideation, Randomized Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- David Lynch FoundationUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Apr 2021 (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 paper describes the rationale and design of a Phase 3 RCT comparing Transcendental Meditation to Present Centered Therapy for posttraumatic stress disorder (PTSD), suicidal ideation, alcohol use, and depressive symptoms in Veterans. In this multisite trial, 450 Veterans meeting Diagnostic and Statistical Manual-5 (DSM-5) criteria for PTSD will be recruited from nine VA and academic medical center sites across the U.S. Study outcomes include changes in PTSD diagnosis and symptom severity (primary), suicidal ideation, alcohol use, and depressive symptoms. Participation includes baseline testing and post-treatment assessments at 12, 24, and 36-weeks. During each assessment visit, Veterans will complete diagnostic interviews, including the Clinician-Administered PTSD Scale for DSM-5 and the Alcohol Timeline Followback, as well as validated self-report measures. Cost-effectiveness of the treatments will be measured using intervention and healthcare costs, the proportion with PTSD diagnosis removed, and Quality-Adjusted Life Years. Finally, single-site substudies will examine pre-to-post-treatment changes in PTSD biomarkers and on magnetic resonance imaging (MRI).
Detailed description
Background: The evidence supporting the Transcendental Meditation (TM) technique as a treatment for posttraumatic stress disorder (PTSD) has advanced considerably in the past decade. With a recent randomized controlled trial (RCT) suggesting statistical superiority to active control treatments for PTSD (e.g., Present Centered Therapy [PCT]) and noninferiority to first-line PTSD psychotherapies, additional research evaluating the benefits and cost-effectiveness of TM for PTSD among Veterans is needed.
Methods and design: This paper describes the rationale and design of a Phase 3 RCT comparing TM to PCT for PTSD in Veterans. In this multisite trial, 450 Veterans meeting DSM-5 criteria for PTSD will be recruited from nine VA and academic medical center sites across the U.S. Study outcomes include changes in PTSD diagnosis and symptom severity (primary), suicidal ideation, alcohol use, and depressive symptoms. Participation includes baseline testing and post-treatment assessments at 12, 24, and 36-weeks. During each assessment visit, Veterans will complete diagnostic interviews, including the Clinician-Administered PTSD Scale for DSM-5 and the Alcohol Timeline Followback, as well as validated self-report measures. Cost-effectiveness of the treatments will be measured using intervention and healthcare costs, the proportion with PTSD diagnosis removed, and Quality-Adjusted Life Years. Finally, single-site substudies will examine pre-to-post-treatment changes in PTSD biomarkers and on magnetic resonance imaging (MRI).
Discussion: Despite progress in PTSD treatments, new evidence-based treatments are still needed for Veterans who drop-out of or respond poorly to existing trauma-focused psychotherapies and that may assist Veterans with common PTSD-comorbidities such as depression, suicidal ideation, and substance use. This multisite trial seeks to advance the science and potential application of TM as a treatment for PTSD in Veterans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 group RCT
| Arm | Type | Receives |
|---|---|---|
| TM | Experimental | Behavioral: TMTranscendental Mediation |
| PCT | Active comparator | Behavioral: PCTPresent Centered Therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Current diagnosis of PTSD from medical record or CAPS-5 interview
- A symptom severity score≥33 on the CAPS-5 indicating clinically significant PTSD symptoms
- Three or more months since trauma
- Agreement to not receive other psychotherapy or meditation for PTSD during the active treatment or follow-up period. Psychotherapy for other problems will be allowed.
- If being treated with psychoactive medications, a stable regimen (no change in drugs or dose) for at least 2 months before enrollment
Key exclusion criteria (5 listed)
- Prior training with TM or treatment with PCT in the past year
- Currently untreated psychotic symptoms or mania symptoms from chart review or self-report
- Moderate or greater cognitive impairment indicated by chart diagnosis or observable cognitive difficulties
- Acute severe symptoms (such as imminent suicidal risk) that will likely require active treatment intervention (such as medication changes) within the course of the study
- Psychiatric hospitalization in the previous six months
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 |
|---|---|---|
| TMTranscendental Meditation instruction, 12-sessions over 3-4 months with monthly follow-up | Behavioural | TM |
| PCTPresent Centered Therapy, 12-sessions over 3-4 months with monthly follow-up | Behavioural | PCT |
Primary outcome
PTSD diagnosis and symptoms
Time frame: Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) changes in PTSD diagnosis and symptom severity. Scores range from 0-80 with higher scores=higher PTSD symptoms
3 secondary outcomes
Depressive symptoms
Time frame: Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Alcohol use
Time frame: Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Suicidal ideation
Time frame: Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Thomas Rutledge, PhD principal investigator
VA San Diego
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TM and PCT in people with Ptsd and Depressive Symptoms, run by David Lynch Foundation.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Rutledge, PhD (8585528585, thomas.rutledge@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD diagnosis and symptoms (time frame: Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2021.