What is the mechanism of action of this treatment?

Common treatments for Post-Traumatic Stress Disorder (PTSD) include meditation and mindfulness-based therapies, such as Transcendental Meditation (TM), which focus on stress reduction and emotional regulation. These therapies work by promoting a state of relaxation and reducing the arousal of the sympathetic nervous system, thereby helping patients manage intrusive thoughts and emotional distress. Cognitive Behavioral Therapy (CBT) and exposure therapy are also widely used; they help patients reframe negative thought patterns and gradually confront traumatic memories in a controlled environment. These mechanisms are vital for PTSD patients as they address the core symptoms of hyperarousal, intrusive memories, and emotional dysregulation, ultimately improving their quality of life.

What side effects are associated with this type of intervention?

Common treatments for PTSD that are similar to Transcendental Meditation (TM) include mindfulness-based stress reduction (MBSR), cognitive-behavioral therapy (CBT), and other forms of meditation. These treatments are generally considered safe with minimal side effects. However, some individuals may experience temporary increases in anxiety, emotional discomfort, or distress as they confront traumatic memories during therapy. Additionally, relaxation-induced panic can occur in rare cases during relaxation or meditation practices. Overall, the benefits of these therapies typically outweigh the risks, making them viable options for managing PTSD symptoms.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Post-Traumatic Stress Disorder (PTSD), including selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. While these medications focus on chemical imbalances in the brain, there is growing interest in non-pharmacological treatments like Transcendental Meditation (TM) for stress reduction and emotional regulation. Although TM itself is not FDA-approved, it is being studied for its potential benefits in managing PTSD symptoms, particularly among veterans and first responders.

What other types of research exist?

Promising alternatives to Transcendental Meditation (TM) for PTSD patients include Mindfulness-Based Stress Reduction (MBSR), Cognitive Behavioral Therapy (CBT), and Yoga. MBSR has been shown to improve symptoms of stress and emotional regulation. CBT is effective in addressing the cognitive aspects of PTSD. Yoga, particularly tailored programs, can help with both physical and emotional symptoms. These therapies have demonstrated benefits in clinical trials and are supported by evidence for their efficacy in managing PTSD symptoms.

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Transcendental Meditation vs Present Centered Therapy for PTSD

N/A

Waitlist Available

Led By Yuval Neria, PhD

Research Sponsored by Research Foundation for Mental Hygiene, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, at 6 weeks, post-treatment: approximately 3 months and 6 months from intake

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated for this trial, common side effects from meditation practices like TM may include discomfort during practice or increased awareness of negative feelings. PCT generally has minimal side effects but could potentially cause distress when discussing traumatic events.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, at 6 weeks, post-treatment: approximately 3 months and 6 months from intake

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, at 6 weeks, post-treatment: approximately 3 months and 6 months from intake

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at 6 weeks, post-treatment: approximately 3 months and 6 months from intake for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in PTSD symptoms over time

Secondary study objectives

Change in depressive symptoms over time

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Present Centered Therapy (PCT):Active Control1 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 Control1 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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Post-Traumatic Stress Disorder (PTSD) include meditation and mindfulness-based therapies, such as Transcendental Meditation (TM), which focus on stress reduction and emotional regulation. These therapies work by promoting a state of relaxation and reducing the arousal of the sympathetic nervous system, thereby helping patients manage intrusive thoughts and emotional distress. Cognitive Behavioral Therapy (CBT) and exposure therapy are also widely used; they help patients reframe negative thought patterns and gradually confront traumatic memories in a controlled environment. These mechanisms are vital for PTSD patients as they address the core symptoms of hyperarousal, intrusive memories, and emotional dysregulation, ultimately improving their quality of life.

Non-trauma-focused meditation versus exposure therapy in veterans with post-traumatic stress disorder: a randomised controlled trial.The Effectiveness of Mindfulness Training in Improving the Quality of Life of the War Victims with Post Traumatic stress disorder (PTSD).