Post-traumatic Stress DisorderNCT01865123
A Randomized Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans
A study testing Transcendental Meditation and Prolonged Exposure in people with Post-traumatic Stress Disorder, run by United States Department of Defense at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of the Transcendental Meditation (TM) program to the more standard Cognitive Behavioral Therapy with Prolonged Exposure (CBT-PE) in treating posttraumatic stress disorder (PTSD) in war Veterans over a three month treatment period. 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?
- Transcendental Meditation and Prolonged Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Aug 2016
- 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
- Current medical diagnosis of PTSD
- A symptom severity score of 45 or higher on the Clinically Administered PTSD Scale (CAPS)
- Three or more months since service-related trauma
- If being treated with psychoactive medication, 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
- 1. Current unstable or uncontrolled psychotic symptoms, mania or bipolar disorder 2. Current suicidal or homicidal ideation 3. Moderate or greater cognitive impairment indicated by chart diagnosis or observable cognitive difficulties 4. Having received Prolonged Exposure therapy or having been instructed in Transcendental Meditation.
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the effectiveness of the Transcendental Meditation (TM) program to the more standard Cognitive Behavioral Therapy with Prolonged Exposure (CBT-PE) in treating posttraumatic stress disorder (PTSD) in war Veterans over a three month treatment period.
Read the detailed description
Posttraumatic stress disorder (PTSD) is a common and debilitating anxiety condition that affects up to 20% of war Veterans. PTSD is often a chronic problem for Veterans, affecting reintegration into society, family and marital relationships, sleep, employment stability, substance abuse rates, and risk for depression and suicide, among other areas. Although several effective therapies exist to treat PTSD, research shows that up to half of patients completing these treatments continue to have elevated symptoms indicating the important need for developing additional treatment options.
In the current trial, we propose to test one such new treatment, specifically a meditation practice known as Transcendental Meditation. The Transcendental Meditation (TM) program will be compared to one of the best and most standard of PTSD therapies (Prolonged Exposure therapy), and a educational control group. This study will recruit 210 War Veterans clinically diagnosed with PTSD from the San Diego VA Healthcare System over a 4 year study period.
The intervention period will be 3 months. Study participants will be randomized equally to one of three study groups, either
- Transcendental Meditation (TM) or
- Cognitive Behavioral Therapy with Prolonged Exposure (CBT-PE) or
- Educational control group.
The primary outcome will be scores on the Clinically Administered PTSD Scale (CAPS).
Secondary outcomes will includes scores on PTSD symptoms including depression, anger, mood disturbance and quality of life.
Behavioral or lifestyle factors will also be measured including smoking, alcohol, and non-described drug usage along with compliance with each treatment.
Physiological markers of stress and disease risk will include cortisol, blood pressure, inflammatory markers and body mass.
If successful, these research findings will serve to provide key data on the feasibility and efficacy of the TM program as an alternative therapy for PTSD. The results will serve to inform policy decisions on the study and application of standardized and validated stress reduction programs in veteran populations.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Transcendental Meditation, Prolonged Exposure, Educational control
- Keywords
- post-traumatic stress disorder, transcendental meditation, cognitive behavioral therapy, prolonged exposure
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcendental MeditationBehavioural
Also called meditation, mantra meditation, stress management
A standard 7 step course will be offered including an introductory and preparatory lectures, personal one-on-one instruction with a certified TM teacher followed by 3 consecutive days of classes on how to meditate correctly and effortlessly, how to understand mechanisms of stress release and sequential development to higher levels of human consciousness and enjoying ones full potential. Followup meetings will provide checking of TM practice, sharing of group experiences with the TM practice and knowledge to motivate and inspire continued regularity with the practice. The certified TM instructor will have experience with PTSD in this veteran population.
Prolonged ExposureBehavioural
Also called Cognitive Behavioral Therapy
Prolonged exposure therapy, a specific form of cognitive behavioral therapy, is considered the standard psychotherapy treatment for PTSD . The delivery of PE will be by a trained study therapist. There will be 16 individual sessions provided to each participant. Homework will include relaxation and breathing exercises and anxiety diaries.
Educational controlBehavioural
Also called Health Education
This group will receive group-administered didactic health education specific to the PTSD veterans population. It will include emphasis on healthy lifestyle changes to promote more positive mental and physical health. The classes will be matched with the TM and PE interventions to control for time, instructor attention and other non-specific factors.
| Study group | Role | What they receive |
|---|---|---|
| Transcendental Meditation | Experimental | TM is a simple, natural, effortless mental technique practiced with eyes closed sitting for 20 minutes twice a day. This allows the practitioner to experience lesser excited levels of the mind and correspondingly greater degrees of physical relaxation. TM is a traditional meditation technique that has its origin in the ancient Vedic tradition of India. Receives: Behavioral: Transcendental Meditation |
| Prolonged Exposure | Active comparator | Prolonged Exposure (PE) is a specialized type of Cognitive Behavorial Therapy employing a manualized, trauma-focused behavioral treatment for PTSD and is based on exposure principles and emotional processing theory. Receives: Behavioral: Prolonged Exposure |
| Educational Control | Placebo comparator | Didactic based instructional classes will provide health education which will include the benefits of proper diet, exercise, and reducing smoking and alcohol. No stress management techniques will be taught. Receives: Behavioral: Educational control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically Administered PTSD Scale (CAPS)
This scale is currently the gold standard for assessing the severity of post-traumatic stress disorder (PTSD) using a face-to-face interview with the patient and a professionally trained medical/psychiatric administrator.
Measured: 3 months
Secondary outcomes (1)
Self-Report Symptoms of PTSD
The PTSD Checklist- Military version (PCL-M) will assess PTSD symptoms in response to stressful military experiences.
The Patient Health Questionnaire (PHQ)-9 will be used to evaluate clinical depression.
The Profile of Mood States (POMS - will be used to evaluate total mood disturbance (TMD) main scale and tension/anxiety, depression/dejection, and anger/hostility subscales.
The Social Support Questionnaire (SSQ) will be used to evaluate level of social support.
The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form will used to assess overall quality of life.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Department of Defense
- Sponsor type
- US federal agency
- Collaborators
- San Diego Veterans Healthcare System, Maharishi University of Management Research Institute, University of California, San Diego
- Responsible party
- Principal investigator, Sanford Nidich, Ed.D., Maharishi International University
- Investigators
- Sanford I Nidich, EdD, Principal investigator, Maharishi University of Management Research InstituteThomas Rutledge, PhD, Principal investigator, San Diego VA Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865123
- Sponsor's protocol ID
- PT110413
- Status last verified
- Nov 2018
- First submitted
- 24 May 2013
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Rutledge T, Nidich S, Schneider RH, Mills PJ, Salerno J, Heppner P, Gomez MA, Gaylord-King C, Rainforth M. Design and rationale of a comparative effectiveness trial evaluating transcendental meditation against established therapies for PTSD. Contemp Clin Trials. 2014 Sep;39(1):50-6. doi: 10.1016/j.cct.2014.07.005. Epub 2014 Jul 25.
PubMed 25066921Nidich S, Mills PJ, Rainforth M, Heppner P, Schneider RH, Rosenthal NE, Salerno J, Gaylord-King C, Rutledge T. Non-trauma-focused meditation versus exposure therapy in veterans with post-traumatic stress disorder: a randomised controlled trial. Lancet Psychiatry. 2018 Dec;5(12):975-986. doi: 10.1016/S2215-0366(18)30384-5. Epub 2018 Nov 15.
PubMed 30449712
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans
- ClinicalTrials.gov ID
- NCT01865123
- Acronym / sponsor ID
- PT110413
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- post-traumatic stress disorder, transcendental meditation, cognitive behavioral therapy, prolonged exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- United States Department of DefenseUS federal agency
- Collaborators
- San Diego Veterans Healthcare System, Maharishi University of Management Research Institute, University of California, San Diego
- Study start
- Jun 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 May 2013 (estimated)
- 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.
The purpose of this study is to compare the effectiveness of the Transcendental Meditation (TM) program to the more standard Cognitive Behavioral Therapy with Prolonged Exposure (CBT-PE) in treating posttraumatic stress disorder (PTSD) in war Veterans over a three month treatment period.
Detailed description
Posttraumatic stress disorder (PTSD) is a common and debilitating anxiety condition that affects up to 20% of war Veterans. PTSD is often a chronic problem for Veterans, affecting reintegration into society, family and marital relationships, sleep, employment stability, substance abuse rates, and risk for depression and suicide, among other areas. Although several effective therapies exist to treat PTSD, research shows that up to half of patients completing these treatments continue to have elevated symptoms indicating the important need for developing additional treatment options.
In the current trial, we propose to test one such new treatment, specifically a meditation practice known as Transcendental Meditation. The Transcendental Meditation (TM) program will be compared to one of the best and most standard of PTSD therapies (Prolonged Exposure therapy), and a educational control group. This study will recruit 210 War Veterans clinically diagnosed with PTSD from the San Diego VA Healthcare System over a 4 year study period.
The intervention period will be 3 months. Study participants will be randomized equally to one of three study groups, either
- Transcendental Meditation (TM) or
- Cognitive Behavioral Therapy with Prolonged Exposure (CBT-PE) or
- Educational control group.
The primary outcome will be scores on the Clinically Administered PTSD Scale (CAPS).
Secondary outcomes will includes scores on PTSD symptoms including depression, anger, mood disturbance and quality of life.
Behavioral or lifestyle factors will also be measured including smoking, alcohol, and non-described drug usage along with compliance with each treatment.
Physiological markers of stress and disease risk will include cortisol, blood pressure, inflammatory markers and body mass.
If successful, these research findings will serve to provide key data on the feasibility and efficacy of the TM program as an alternative therapy for PTSD. The results will serve to inform policy decisions on the study and application of standardized and validated stress reduction programs in veteran populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcendental Meditation | Experimental | Behavioral: Transcendental MeditationTM is a simple, natural, effortless mental technique practiced with eyes closed sitting for 20 minutes twice a day. This allows the practitioner to experience lesser excited levels of the mind and correspondingly greater degrees of physical relaxation. TM is a traditional meditation technique that has its origin in the ancient Vedic tradition of India. |
| Prolonged Exposure | Active comparator | Behavioral: Prolonged ExposureProlonged Exposure (PE) is a specialized type of Cognitive Behavorial Therapy employing a manualized, trauma-focused behavioral treatment for PTSD and is based on exposure principles and emotional processing theory. |
| Educational Control | Placebo comparator | Behavioral: Educational controlDidactic based instructional classes will provide health education which will include the benefits of proper diet, exercise, and reducing smoking and alcohol. No stress management techniques will be taught. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Current medical diagnosis of PTSD
- A symptom severity score of 45 or higher on the Clinically Administered PTSD Scale (CAPS)
- Three or more months since service-related trauma
- If being treated with psychoactive medication, a stable regimen (no change in drugs or dose) for at least 2 months before enrollment
- Age: 18 years or older
Key exclusion criteria (2 listed)
- 1. Current unstable or uncontrolled psychotic symptoms, mania or bipolar disorder 2. Current suicidal or homicidal ideation 3. Moderate or greater cognitive impairment indicated by chart diagnosis or observable cognitive difficulties 4. Having received Prolonged Exposure therapy or having been instructed in Transcendental Meditation.
- -
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 |
|---|---|---|
| Transcendental MeditationAlso: meditation, mantra meditation, stress managementA standard 7 step course will be offered including an introductory and preparatory lectures, personal one-on-one instruction with a certified TM teacher followed by 3 consecutive days of classes on how to meditate correctly and effortlessly, how to understand mechanisms of stress release and sequential development to higher levels of human consciousness and enjoying ones full potential. Followup meetings will provide checking of TM practice, sharing of group experiences with the TM practice and knowledge to motivate and inspire continued regularity with the practice. The certified TM instructor will have experience with PTSD in this veteran population. | Behavioural | Transcendental Meditation |
| Prolonged ExposureAlso: Cognitive Behavioral TherapyProlonged exposure therapy, a specific form of cognitive behavioral therapy, is considered the standard psychotherapy treatment for PTSD . The delivery of PE will be by a trained study therapist. There will be 16 individual sessions provided to each participant. Homework will include relaxation and breathing exercises and anxiety diaries. | Behavioural | Prolonged Exposure |
| Educational controlAlso: Health EducationThis group will receive group-administered didactic health education specific to the PTSD veterans population. It will include emphasis on healthy lifestyle changes to promote more positive mental and physical health. The classes will be matched with the TM and PE interventions to control for time, instructor attention and other non-specific factors. | Behavioural | Educational Control |
Primary outcome
Clinically Administered PTSD Scale (CAPS)
Time frame: 3 months
This scale is currently the gold standard for assessing the severity of post-traumatic stress disorder (PTSD) using a face-to-face interview with the patient and a professionally trained medical/psychiatric administrator.
1 secondary outcome
Self-Report Symptoms of PTSD
Time frame: 3 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 26 Nov 2018.
- Background: PubMed 25066921Rutledge T, Nidich S, Schneider RH, Mills PJ, Salerno J, Heppner P, Gomez MA, Gaylord-King C, Rainforth M. Design and rationale of a comparative effectiveness trial evaluating transcendental meditation against established therapies for PTSD. Contemp Clin Trials. 2014 Sep;39(1):50-6. doi: 10.1016/j.cct.2014.07.005. Epub 2014 Jul 25.
- Results publication: PubMed 30449712Nidich S, Mills PJ, Rainforth M, Heppner P, Schneider RH, Rosenthal NE, Salerno J, Gaylord-King C, Rutledge T. Non-trauma-focused meditation versus exposure therapy in veterans with post-traumatic stress disorder: a randomised controlled trial. Lancet Psychiatry. 2018 Dec;5(12):975-986. doi: 10.1016/S2215-0366(18)30384-5. Epub 2018 Nov 15.
- online version of article released Nov 15, 2018Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Sanford I Nidich, EdD principal investigator
Maharishi University of Management Research Institute
Thomas Rutledge, PhD principal investigator
San Diego VA Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcendental Meditation and Prolonged Exposure in people with Post-traumatic Stress Disorder, run by United States Department of Defense at 1 site in United States.
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 6 inclusion and 2 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 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?
Clinically Administered PTSD Scale (CAPS) (time frame: 3 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 NCT01865123, which also lists 2 linked publications.
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 26 Nov 2018; AzTrials last refreshed its copy on 6 Nov 2026.