Mindfulness-Based Exposure Therapy for PTSD After Cardiac Arrest

YN
MB
Overseen ByMaja Bergman, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
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 whether Acceptance- and Mindfulness-Based Exposure Therapy (AMBET) can reduce PTSD symptoms in cardiac arrest survivors. It compares AMBET to Present Centered Therapy (PCT) to determine which is more effective. Participants will attend therapy sessions, complete weekly mood surveys, and monitor their sleep and activity with a Fitbit. This trial suits English-speaking U.S. residents who experienced a cardiac arrest over three months ago and have PTSD symptoms. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance PTSD treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you started a new psychotropic medication less than 3 months ago, you may not be eligible to participate.

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

A previous study found that Acceptance and Mindfulness-Based Exposure Therapy (AMBET) was safe and well-tolerated by participants. This therapy aims to reduce PTSD (post-traumatic stress disorder) symptoms in cardiac arrest survivors. The initial trial showed that AMBET is not only feasible but also might help reduce PTSD symptoms.

Present Centered Therapy (PCT), the other treatment in this trial, helps people manage stress and challenges in daily life. Both therapies are provided remotely, either online or over the phone, making them easily accessible.

Overall, AMBET has shown promise as a safe option for treating PTSD in cardiac arrest survivors. This trial will determine how it compares to PCT in terms of effectiveness.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for PTSD after cardiac arrest because they take a novel approach by incorporating mindfulness and acceptance techniques. Unlike standard PTSD treatments, such as Cognitive Behavioral Therapy (CBT) or medication, Acceptance and Mindfulness-Based Exposure Therapy (AMBET) combines exposure therapy with mindfulness practices, delivered remotely. This innovative method aims to help patients confront and accept their traumatic experiences while staying present in the moment, potentially offering a more holistic and accessible approach to healing. Present-Centered Therapy (PCT), another treatment in the trial, focuses on equipping patients with skills to handle current stressors, which may provide practical, immediate relief.

What evidence suggests that this trial's therapies could be effective for PTSD after cardiac arrest?

Research has shown that Acceptance- and Mindfulness-Based Exposure Therapy (AMBET), one of the therapies studied in this trial, may reduce PTSD symptoms in people who have survived sudden cardiac arrest. Early results suggest that AMBET is safe and might be effective for this group. This therapy combines exposure therapy, which helps people face their fears, with mindfulness, which encourages staying in the present moment. Studies have found that this approach can help reduce PTSD symptoms by teaching patients how to better handle stress and anxiety. Present Centered Therapy (PCT) is another therapy compared in this trial. It focuses on dealing with current life challenges and stress. Both therapies aim to improve PTSD symptoms, but more research is needed to determine which one works better.12346

Who Is on the Research Team?

YN

Yuval Neria, PhD

Principal Investigator

Columbia University

MB

Maja Bergman, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for U.S. residents aged 18-81 who speak English, survived a cardiac arrest over 3 months ago, and are experiencing PTSD symptoms (with a CAPS-5 score ≥25).

Inclusion Criteria

Fluency in English
I had a cardiac arrest more than 3 months ago.
U.S. Resident
See 2 more

Exclusion Criteria

Substantial cognitive impairment (Mini Mental Status Exam (MMSE) score <25)
I started a new mental health medication less than 3 months ago.
Terminal illness with life expectancy <1 year
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either AMBET or PCT therapy, attend 12 hours of psychotherapy sessions over about 12 weeks, complete weekly surveys, and wear a Fitbit device

12 weeks
12 sessions (remote)

Follow-up

Participants are monitored for changes in PTSD and depressive symptoms post-treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Acceptance and Mindfulness Based Exposure Therapy
  • Present Centered Therapy

Trial Overview

The study compares Acceptance and Mindfulness-Based Exposure Therapy (AMBET) with Present Centered Therapy (PCT) to see which is more effective in treating PTSD after cardiac arrest. Participants will undergo 12 hours of therapy over roughly 12 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Acceptance- and mindfulness-based exposure therapy (AMBET)Experimental Treatment1 Intervention
Group II: Present-Centered Therapy (PCT)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38019593/

Acceptance and Mindfulness-Based Exposure Therapy for ...

This initial trial found AMBET feasible, safe, and potentially efficacious in reducing PTSD following SCA. These encouraging pilot results warrant further ...

Acceptance and Mindfulness Based Exposure Therapy for ...

The specific aims of this study are to: (1) develop an acceptable protocol for an AMBET intervention for survivors of sudden cardiac arrest with elevated PTSD ...

Mindfulness-based Therapy Shows Promise for Reducing ...

A novel treatment that incorporates mindfulness into exposure therapy shows promise for reducing symptoms of post-traumatic stress in survivors of sudden ...

Acceptance and Mindfulness-Based Exposure Therapy for ...

Conclusions: This initial trial found AMBET feasible, safe, and potentially efficacious in reducing PTSD following SCA. These encouraging pilot results warrant ...

Trial of Acceptance and Mindfulness-based Exposure ...

This study will compare AMBET to another psychotherapy treatment called Present Centered Therapy (PCT) to see which therapy is more effective in treating PTSD.

Acceptance and Mindfulness-Based Exposure Therapy for ...

Exposure therapy is standard treatment for PTSD, but its safety and efficacy remain unconfirmed for SCA survivors: current protocols do not address their ...