Anxiety & Depression Association of America

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

Purpose

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

Conditions

PTSD - Post Traumatic Stress Disorder
Cardiac Arrest (CA)

Eligibility

Eligible Ages: Between 18 Years and 81 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Single (Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Acceptance- and mindfulness-based exposure therapy (AMBET)	Remotely delivered psychotherapy combining exposure therapy with mindfulness.	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. Other names: AMBET
Active Comparator Present-Centered Therapy (PCT)	Remotely delivered psychotherapy that focuses on increasing adaptive responses to current life stressors and difficulties.	Behavioral: Present-Centered Therapy Twelve 60-minute weekly sessions of psychotherapy delivered via videoconferencing platform. Other names: PCT

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Columbia University

Study Contact

Yuval Neria, Ph.D.
212-543-6061
ny126@cumc.columbia.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.