Transcendental Meditation vs Present Centered Therapy for PTSD

No longer recruiting at 4 trial locations
YN
MR
Overseen ByMatthew Ryba, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Research Foundation for Mental Hygiene, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two therapies—Transcendental Meditation (TM) and Present Centered Therapy (PCT)—can assist veterans and first responders with PTSD (Post-Traumatic Stress Disorder). TM aims to reduce stress and enhance well-being through a simple meditation technique, while PCT focuses on improving how individuals manage life stressors related to their trauma. Researchers aim to evaluate the effectiveness of each treatment and observe any changes in brain activity using MRI scans. Individuals who have served in the military or as first responders and have experienced PTSD symptoms for at least three months might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding PTSD treatments without the constraints of traditional clinical trial phases.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Transcendental Meditation (TM) and Present Centered Therapy (PCT) are generally safe for treating PTSD.

For TM, studies have found it effectively reduces PTSD symptoms without major safety concerns. One review showed that TM reduces PTSD symptoms by 21% more than other therapies. TM is well-tolerated, with no serious side effects reported.

PCT is also considered safe. Several studies have noted that people tend to continue with PCT, suggesting it is well-tolerated. Designed to help manage stress related to PTSD, PCT has been shown to be effective without major negative effects.

Overall, both TM and PCT appear to be safe options for managing PTSD, with evidence supporting their safety and effectiveness.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for PTSD because they offer unique, non-traditional approaches to managing the condition. Present Centered Therapy (PCT) is distinct because it emphasizes adaptive responses to current life stressors, which may result in lower dropout rates compared to trauma-focused cognitive-behavioral therapies. Transcendental Meditation (TM), on the other hand, stands out for its ability to promote deep relaxation and well-being through effortless meditation, potentially reducing stress more naturally and holistically. These methods differ from standard PTSD treatments like medication and exposure therapy by focusing on present-centered awareness and stress reduction without intensive trauma exposure.

What evidence suggests that this trial's treatments could be effective for PTSD?

This trial will compare Transcendental Meditation (TM) with Present Centered Therapy (PCT) for treating PTSD. Research has shown that TM can greatly reduce PTSD symptoms, helping to lower stress and improve mental health in veterans, leading to better mental clarity and resilience. Meanwhile, PCT is another promising treatment for PTSD. Several clinical trials have found that PCT effectively helps people manage stress and trauma-related challenges and may have fewer dropouts compared to other trauma-focused therapies. Both TM and PCT are considered effective treatments for those dealing with PTSD.23678

Who Is on the Research Team?

YN

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.
See 2 more

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)
See 13 more

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?
2Treatment groups
Active Control
Group I: Present Centered Therapy (PCT):Active Control1 Intervention
Group II: Transcendental Meditation (TM):Active Control1 Intervention

Find a Clinic Near You

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) 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.
The evidence for present-centered therapy as a treatment for posttraumatic stress disorder.Frost, ND., Laska, KM., Wampold, BE.[2022]
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.
Present-centered therapy (PCT) for post-traumatic stress disorder (PTSD) in adults.Belsher, BE., Beech, E., Evatt, D., et al.[2022]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39768929/
Effectiveness of Meditation Techniques in Treating Post- ...All categories of meditation studied were helpful in mitigating symptoms of PTSD. TM produced clinically significant reductions in PTSD in all trauma groups.
Cost-effectiveness of Transcendental Meditation (TM) for ...A recent trial found that Transcendental Meditation (TM) was an effective non-trauma focused treatment for veterans with Post-Traumatic Stress Disorder (PTSD).
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/33734493/
A Pilot Randomized Controlled Trial of Transcendental ...Preliminary studies have demonstrated the efficacy of Transcendental Meditation (TM) for treating posttraumatic stress disorder (PTSD).
A Randomized Controlled Trial of Meditation Compared to ...The purpose of this study is to compare the effectiveness of the Transcendental Meditation (TM) program to the more standard Cognitive Behavioral Therapy ...
Evaluating the effectiveness of Transcendental Meditation ...Post-intervention, TM participants had significantly higher results in mental clarity (t = 3.347, p = 0.010), trait resilience (t = 2.630, p = ...
Systematic Review and Meta-Analysis of Transcendental ...However, TM produced a 21% greater reduction in global PTSD symptoms than PE at posttest, as shown in Figure 1. Moreover, TM reduced PTSD symptoms faster than ...
Transcendental meditation greatly reduces PTSD ...The average reduction in PTSD symptoms from pretest to posttest was moderate (effect size = 0.67). Separate tests found TM treatment had a large ...
Transcendental Meditation Program's Impact on the ...The psychotherapy group experienced no improvement, whereas the TM group improved significantly on eight variables, including a 40% decline in ...
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