Trial of Acceptance and Mindfulness-based Exposure Therapy (AMBET) and Present Centered Therapy (PCT)

Columbia University

Status: Enrolling

Conditions: PTSD - Post Traumatic Stress Disorder; Cardiac Arrest (CA)

Treatments: Behavioral: Present-Centered Therapy; Behavioral: Acceptance and Mindfulness Based Exposure Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07410481

P30AG064198-06 (U.S. NIH Grant/Contract)

AAAV5860

Details and patient eligibility

About

The goal of this clinical trial is to learn if a new therapy called Acceptance- and Mindfulness-Based Exposure Therapy (AMBET) helps treat post-traumatic stress disorder (PTSD) in people who survived a cardiac arrest. This study will compare AMBET to another psychotherapy treatment called Present Centered Therapy (PCT) to see which therapy is more effective in treating PTSD.

The main questions it aims to answer are:

Does AMBET reduce PTSD symptoms in survivors of cardiac arrest? How do the benefits of AMBET compare to PCT?

Participants will:

• Be randomly assigned to receive either AMBET or PCT
• Attend 12 hours of individual psychotherapy sessions over about 12 weeks
• Complete short weekly surveys about their mood and behaviors online
• Wear a Fitbit device to track sleep and activity during the study
• Do brief homework assignments between sessions

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 81 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Between 18 and 81 years old at the time of consent
2. Fluency in English
3. Medical history of cardiac arrest >3 months ago
4. Clinically elevated PTSD symptoms (Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score ≥25)
5. U.S. Resident

Exclusion criteria

1. Lifetime history of primary psychotic or bipolar disorders
2. Current substance use disorder (moderate or severe in the past 6 months)
3. Active suicidal ideation with some intent to act in past 12 months, and/or suicide attempt in past 24 months
4. Substantial cognitive impairment (Mini Mental Status Exam (MMSE) score <25)
5. Initiation of new psychotropic medication <3 months ago
6. Non-cardiac etiology of CA (drowning, bleeding, trauma, drug overdose, etc)
7. Terminal illness with life expectancy <1 year
8. Concurrent psychotherapy for PTSD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Acceptance- and mindfulness-based exposure therapy (AMBET)

Experimental group

Description:

Remotely delivered psychotherapy combining exposure therapy with mindfulness.

Treatment:

Behavioral: Acceptance and Mindfulness Based Exposure Therapy

Present-Centered Therapy (PCT)

Active Comparator group

Description:

Remotely delivered psychotherapy that focuses on increasing adaptive responses to current life stressors and difficulties.

Treatment:

Behavioral: Present-Centered Therapy