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

ConditionsPTSD - Post Traumatic Stress Disorder Cardiac Arrest (CA)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-81

SponsorColumbia University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Acceptance and Mindfulness Based Exposure Therapy
Behavioral
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.
Present-Centered Therapy
Behavioral
Twelve 60-minute weekly sessions of psychotherapy delivered via videoconferencing platform.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Acceptance- and mindfulness-based exposure therapy (AMBET)Experimental treatment 1 intervention

Group B: Present-Centered Therapy (PCT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Change in PTSD symptoms over time

Change in symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5) from pre- to post-treatment. The full score range is 0 - 80, where lower scores indicate lower symptom levels of PTSD.

Time frame

Baseline, At 6 weeks, Post-treatment: Approximately 3 months and 6 months from intake

Secondary outcomes

Change in depressive symptoms over time

Change in symptoms as measured by the Hamilton Depression Rating Scale (HDRS-24) from pre- to post-treatment. The full score range is 0 - 76, where lower scores indicate lower symptom levels of depression.

Time frame

Baseline, At 6 weeks, Post-treatment: approximately 3 months and 6 months from intake

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov

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