PTSD - Post Traumatic Stress DisorderNCT07410481
Trial of Acceptance and Mindfulness-based Exposure Therapy (AMBET) and Present Centered Therapy (PCT)
A study testing Acceptance and Mindfulness Based Exposure Therapy and Present-Centered Therapy in people with PTSD - Post Traumatic Stress Disorder and Cardiac Arrest (CA), run by Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder, Cardiac Arrest (CA)
- What is being tested?
- Acceptance and Mindfulness Based Exposure Therapy and Present-Centered Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Maja Bergman, Ph.D., mb3829@cumc.columbia.edu
Yuval Neria
About this study
Official title: A Randomized Clinical Trial of Acceptance and Mindfulness-based Exposure Therapy (AMBET) and Present Centered Therapy (PCT)
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:
Read more
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
- Being tested
- Acceptance and Mindfulness Based Exposure Therapy, Present-Centered Therapy
- Medical subject headings
- Combat Disorders, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Mindfulness Based Exposure TherapyBehavioural
Also called AMBET
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 TherapyBehavioural
Also called PCT
Twelve 60-minute weekly sessions of psychotherapy delivered via videoconferencing platform.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance- and mindfulness-based exposure therapy (AMBET) | Experimental | Remotely delivered psychotherapy combining exposure therapy with mindfulness. Receives: Behavioral: Acceptance and Mindfulness Based Exposure Therapy |
| Present-Centered Therapy (PCT) | Active comparator | Remotely delivered psychotherapy that focuses on increasing adaptive responses to current life stressors and difficulties. Receives: Behavioral: Present-Centered Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, At 6 weeks, Post-treatment: Approximately 3 months and 6 months from intake
Secondary outcomes (1)
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.
Measured: Baseline, At 6 weeks, Post-treatment: approximately 3 months and 6 months from intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start31 Mar 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Yuval Neria, Columbia University
- Investigators
- Yuval Neria, PhD, Principal investigator, Columbia UniversityMaja Bergman, PhD, Study director, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410481
- Sponsor's protocol ID
- AAAV5860
- Other IDs
- P30AG064198-06
- Status last verified
- Apr 2026
- First submitted
- 8 Feb 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Acceptance and Mindfulness-based Exposure Therapy (AMBET) and Present Centered Therapy (PCT)
- ClinicalTrials.gov ID
- NCT07410481
- Acronym / sponsor ID
- AAAV5860
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance- and mindfulness-based exposure therapy (AMBET) | Experimental | Behavioral: Acceptance and Mindfulness Based Exposure TherapyRemotely delivered psychotherapy combining exposure therapy with mindfulness. |
| Present-Centered Therapy (PCT) | Active comparator | Behavioral: Present-Centered TherapyRemotely delivered psychotherapy that focuses on increasing adaptive responses to current life stressors and difficulties. |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Mindfulness Based Exposure TherapyAlso: AMBETEight 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. | Behavioural | Acceptance- and mindfulness-based exposure therapy (AMBET) |
| Present-Centered TherapyAlso: PCTTwelve 60-minute weekly sessions of psychotherapy delivered via videoconferencing platform. | Behavioural | Present-Centered Therapy (PCT) |
Primary outcome
Change in PTSD symptoms over time
Time frame: Baseline, At 6 weeks, Post-treatment: Approximately 3 months and 6 months from intake
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.
1 secondary outcome
Change in depressive symptoms over time
Time frame: Baseline, At 6 weeks, Post-treatment: approximately 3 months and 6 months from intake
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuval Neria, PhD principal investigator
Columbia University
Maja Bergman, PhD study director
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Mindfulness Based Exposure Therapy and Present-Centered Therapy in people with PTSD - Post Traumatic Stress Disorder and Cardiac Arrest (CA), run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuval Neria, Ph.D. (212-543-6061, ny126@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptoms over time (time frame: Baseline, At 6 weeks, Post-treatment: Approximately 3 months and 6 months from intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.