Trial of Acceptance and Mindfulness-based Exposure Therapy (AMBET) and Present Centered Therapy (PCT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acceptance and Mindfulness Based Exposure Therapy, Present-Centered Therapy.
- Who it may be relevant to
- Registry conditions: PTSD - Post Traumatic Stress Disorder, Cardiac Arrest (CA). Basic parameters: 18 years — 81 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Clinical Trial of Acceptance and Mindfulness-based Exposure Therapy (AMBET) and Present Centered Therapy (PCT)
Overview
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
Interventions
- Behavioral Acceptance and Mindfulness Based Exposure Therapy
Eight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform. AMBET will consist of 90-minute weekly sessions for 4 weeks, then every other week for 4 more sessions. - Behavioral Present-Centered Therapy
Twelve 60-minute weekly sessions of psychotherapy delivered via videoconferencing platform.
Primary outcome measures
- Change in PTSD symptoms over time [Time frame: Baseline, At 6 weeks, Post-treatment: Approximately 3 months and 6 months from intake]
Secondary outcome measures (1)
- Change in depressive symptoms over time [Time frame: Baseline, At 6 weeks, Post-treatment: approximately 3 months and 6 months from intake]
Eligibility criteria
Inclusion criteria
- Between 18 and 81 years old at the time of consent
- Fluency in English
- Medical history of cardiac arrest >3 months ago
- Clinically elevated PTSD symptoms (Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score ≥25)
- U.S. Resident
Exclusion criteria
- Lifetime history of primary psychotic or bipolar disorders
- Current substance use disorder (moderate or severe in the past 6 months)
- Active suicidal ideation with some intent to act in past 12 months, and/or suicide attempt in past 24 months
- Substantial cognitive impairment (Mini Mental Status Exam (MMSE) score <25)
- Initiation of new psychotropic medication <3 months ago
- Non-cardiac etiology of CA (drowning, bleeding, trauma, drug overdose, etc)
- Terminal illness with life expectancy <1 year
- Concurrent psychotherapy for PTSD
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Columbia University Irving Medical Center — New York
Identifiers
NCT: NCT07410481 · AAAV5860 · P30AG064198-06