Transcendental Meditation vs Present Centered Therapy for PTSD

Recruiting at 4 trial locations

Overseen By Matthew Ryba, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Research Foundation for Mental Hygiene, Inc.

Must not be taking: Psychotropics

Disqualifiers: Psychosis, Bipolar, Suicidal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, Transcendental Meditation (TM) and Present Centered Therapy (PCT), for veterans and first responders with PTSD. TM uses meditation to calm the nervous system, while PCT focuses on current issues and coping strategies. Early research shows that Transcendental Meditation (TM) can help with PTSD. The goal is to find helpful treatments for PTSD in this group.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does mention that you should not change the dosage of or start new psychotropic medications during the study. If you have recently changed your medication dosage or started a new one within the last three months, you may not be eligible to participate.

Is Transcendental Meditation safe for humans?

Research on Transcendental Meditation (TM) for PTSD in various groups, including veterans and refugees, shows it is generally safe with no reported adverse events. Participants were able to practice TM successfully, and it was well-tolerated. ^{1 2 3 4 5}

How does the treatment of Transcendental Meditation differ from other treatments for PTSD?

Transcendental Meditation (TM) is unique because it involves using a mantra to facilitate meditation, which is a non-drug approach to managing PTSD symptoms. Unlike traditional therapies that focus on discussing trauma, TM offers a mental technique that can be practiced independently, potentially reducing stress and improving mental well-being. ^{1 4 6 7 8}

What data supports the effectiveness of the treatment Transcendental Meditation (TM) for PTSD?

Research shows that Transcendental Meditation (TM) can help reduce PTSD symptoms. In one study, veterans practicing TM had significant improvements in PTSD symptoms, with 50% no longer meeting PTSD criteria, compared to 10% in the control group. Another study found that TM reduced the need for medications in military members with PTSD. ^{1 2 4 5 7}

Who Is on the Research Team?

Yuval Neria, PhD

Principal Investigator

NYSPI and Columbia University

Are You a Good Fit for This Trial?

This trial is for right-handed veterans and first responders aged 18-80 with PTSD, who can consent and are English literate. They must have a CAPS-5 score ≥ 25 and symptoms for at least 3 months. Exclusions include severe substance use disorders (except nicotine), unstable medical conditions, certain metal implants, claustrophobia in MRI scanners, recent psychiatric hospitalization or medication changes, pregnancy/breastfeeding women, current psychotherapy or meditation therapy users.

Inclusion Criteria

Prior or current military service OR prior or current work as a first responder (law enforcement, firefighters, and EMS)

Able to give consent, English literate

I have been diagnosed with PTSD and have had symptoms for at least 3 months.

Exclusion Criteria

Active suicidal or homicidal ideation or suicide attempt within two years of study enrollment

I haven't changed or started any mental health medications in the last 3 months.

Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body (for MRI)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Transcendental Meditation (TM) or Present Centered Therapy (PCT) for PTSD

6 weeks

5 assessments (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (remote)

What Are the Treatments Tested in This Trial?

Interventions

• Present Centered Therapy (PCT)
• Transcendental Meditation (TM)

Trial Overview The study compares Transcendental Meditation (TM) with Present Centered Therapy (PCT) in treating PTSD. Participants will be randomly assigned to one of the treatments and assessed five times over six months via videoconferencing. The New York State Psychiatric Institute/Columbia protocol includes pre-and post-treatment MRIs to study brain changes.

How Is the Trial Designed?

Group I: Present Centered Therapy (PCT): Active Control 1 Intervention

PCT is a focused time-limited treatment for PTSD that focuses on increasing adaptive responses to current life stressors and difficulties that are directly or indirectly related to trauma or PTSD symptoms. PCT was originally designed as a treatment comparator in trials evaluating the effectiveness of trauma-focused cognitive-behavioral therapies such as PE and CPT. Several clinical trials have indicated that PCT may be an effective treatment option for PTSD and that patients may drop out of PCT at lower rates relative to trauma focused forms of CBT.

Group II: Transcendental Meditation (TM): Active Control 1 Intervention

TM treatment for PTSD is designed to reduce stress, facilitate deep rest, and increase well-being. It was originally conceptualized as an effortless technique to enable physical relaxation. The treatment will be delivered by experienced, certified TM instructors receiving weekly supervision.

Who Is Running the Clinical Trial?

Research Foundation for Mental Hygiene, Inc.

Lead Sponsor

Trials

68

Recruited

21,100+

Mount Sinai Hospital, New York

Collaborator

Trials

37

Recruited

892,000+

David Lynch Foundation

Collaborator

Trials

4

Recruited

940+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

New York State Psychiatric Institute

Collaborator

Trials

481

Recruited

154,000+

Northwell Health

Collaborator

Trials

481

Recruited

470,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

Present-centered therapy (PCT) is more effective than control conditions in reducing PTSD severity, with moderate-quality evidence from 12 studies involving 1837 participants.

While PCT showed lower dropout rates compared to trauma-focused cognitive-behavioral therapy (TF-CBT), it did not demonstrate non-inferiority to TF-CBT in alleviating PTSD symptoms, suggesting that while PCT is beneficial, TF-CBT may still be more effective overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Present-centered therapy (PCT) for post-traumatic stress disorder (PTSD) in adults. Belsher, BE., Beech, E., Evatt, D., et al.[2022]

Present-centered therapy (PCT) has been shown to be as effective as existing evidence-based treatments for PTSD in 3 out of 5 randomized clinical trials, with large effect sizes in cases where no treatment was provided.

PCT also had a significantly lower dropout rate (14.3%) compared to other treatments (31.3%), indicating it may be a more acceptable option for patients with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evidence for present-centered therapy as a treatment for posttraumatic stress disorder. Frost, ND., Laska, KM., Wampold, BE.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Clinical case series: treatment of PTSD with transcendental meditation in active duty military personnel. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Impact of Transcendental Meditation on Psychotropic Medication Use Among Active Duty Military Service Members With Anxiety and PTSD. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial of Transcendental Meditation as Treatment for Posttraumatic Stress Disorder in Veterans. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Transcendental meditation for veterans with post-traumatic stress disorder. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effects of transcendental meditation in veterans of Operation Enduring Freedom and Operation Iraqi Freedom with posttraumatic stress disorder: a pilot study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Reduction in posttraumatic stress symptoms in Congolese refugees practicing transcendental meditation. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Present-centered therapy (PCT) for post-traumatic stress disorder (PTSD) in adults. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The evidence for present-centered therapy as a treatment for posttraumatic stress disorder. [2022]