Acute Coronary SyndromeNCT03605693
Early Psychological Intervention to Prevent Cardiovascular Event-Induced PTSD (REACH Sub-study)
A study testing Written Exposure Therapy in people with Acute Coronary Syndrome and TIA, run by Columbia University at 1 site in United States.
Trial summary
The overall purpose of this project is to determine the feasibility of conducting a randomized clinical trial that compares written exposure therapy with usual care among patients at risk for cardiovascular event-induced PTSD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, TIA, Stroke
- What is being tested?
- Written Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized with acute stroke, TIA, ACS, or cardiac arrest
- Enrolled in REACH-stroke, PHS, or REACH-cardiac arrest observational cohort studies
- Elevated ASD symptoms (ASD score >=28) and/or elevated threat perceptions during index hospitalization (ED threat score >=12)
Who cannot join
- Unavailable for follow-up for written exposure therapy sessions
- Unable to read and write in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Behavioral Cardiovascular Health
New York, New York, 10032
About this study
Official title: Written Exposure Therapy to Prevent PTSD in Survivors of Acute Cardiovascular Events: A Pilot Randomized Clinical Trial
The overall purpose of this project is to determine the feasibility of conducting a randomized clinical trial that compares written exposure therapy with usual care among patients at risk for cardiovascular event-induced PTSD.
Patients hospitalized with acute cardiovascular events, including strokes, heart attacks, and cardiac arrest are at risk of developing post-traumatic stress disorder (PTSD) due to the trauma of the acute medical event. The goal of this study is to test the feasibility of conducting a randomized trial involving a psychological intervention to prevent the development of PTSD symptoms in patients at risk for PTSD. Patients who are admitted with these acute cardiovascular events will first be screened for PTSD risk factors while in-hospital after the index event. These risk factors will include elevated threat perceptions at the time of presentation to the hospital or early symptoms of PTSD due to the cardiovascular event. Patients at elevated risk for PTSD will then be randomized to the intervention group or usual care. Those assigned to the intervention will participate in 5 sessions of written exposure therapy in which they are asked to write about the experience of their cardiovascular event with guidance from a trained study clinician. At 1 month after discharge, all patients will be contacted by phone to complete a questionnaire that assesses PTSD symptoms related to the cardiovascular event. Descriptive statistics will be used to understand the feasibility of testing the written exposure therapy intervention as part of a larger, fully powered clinical trial.
Read the detailed description
Experiencing a life threatening cardiovascular event, such as a stroke, transient ischemic attack (TIA), acute coronary syndrome (ACS), or cardiac arrest has been found to be associated with PTSD symptoms in up to 1 in 3 survivors. Patients with elevated PTSD symptoms are at risk for lower medication adherence, increased readmissions, recurrent cardiovascular events, and worsened quality of life. Risk for recurrent cardiovascular events is especially high in the initial weeks after acute cardiovascular events, and existing epidemiological data suggest that PTSD symptoms increase this risk. Thus, intervening early to prevent PTSD symptoms prior to waiting the full one or more months to make a PTSD diagnosis may provide new opportunities for offsetting cardiovascular disease (CVD) risk. Despite these adverse consequence of cardiovascular event-induced PTSD, these patients are not currently being systematically screened or treated to prevent PTSD symptoms, in part because there is no evidence assessing the effect of early interventions in this patient population.
A growing number of studies have been evaluating early interventions after trauma to prevent PTSD. While there is no gold-standard intervention, psychological interventions grounded in trauma-focused, cognitive behavioral therapy (CBT) have shown promise in some populations. For example, compared to a supportive counseling control condition, CBT has been found to reduce PTSD symptom severity and incidence in individuals with acute stress disorder (ASD), an early manifestation of posttraumatic stress, detected within the first month of a traumatic event. Preliminary research suggests that an exposure-based CBT intervention delivered in the immediate aftermath of trauma for individuals meeting Criterion A of a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) PTSD diagnosis may also hold promise for PTSD prevention. Acute cardiovascular events such as stroke and ACS as the source of trauma are inherently different from other forms of stressors that commonly lead to PTSD. As opposed to an external and past traumatic threat (e.g., combat, physical/emotional abuse), these events can represent an ongoing internal somatic threat. Accordingly, treatments for preventing PTSD such as the trauma-focused CBT interventions discussed above need to be formally evaluated in this distinct patient population before generalizing the findings from other patient populations. In particular, the willingness to engage in therapies to prevent or reduce PTSD symptoms may differ in this patient population. Few of these patients are actively seeking treatment. Many may not be aware of potential psychological symptoms that can begin or worsen after these events and may not perceive their psychological symptoms to be problematic. Hence, the acceptability of psychological interventions is particularly relevant in this patient population.
Written exposure therapy represents a promising intervention to prevent PTSD after cardiovascular events. Written exposure therapy is a brief exposure-based therapy, founded on the principles of Pennebaker and Beale's written disclosure procedure. The treatment protocol consists of 5 sessions, each comprising 30 minutes of writing. In each session, participants are instructed to write about their memory of the traumatic event with particular attention to the felt emotions and the meaning of the event. The initial session also incorporates psychoeducation and review of the rationale for the intervention by a study clinician. Sessions end with therapists' discussing how the writing session went. The rationale behind this exposure therapy is that there is a significant habituation of emotional reactivity to reminders of the traumatic event over repeated writing sessions. Consistent with this rationale, research suggests that these exposure writing sessions are associated with greater initial emotional and physiological reactivity and greater habituation of these responses over time compared to a control writing condition. A recent study showed that this brief psychotherapy approach was non-inferior to a more extensive CBT approach (cognitive processing therapy) for reducing PTSD symptoms in adults with PTSD. Written exposure therapy has also been shown to be effective at lowering PTSD symptoms in patients with motor vehicle accident-induced PTSD.
In contrast with more standard CBT interventions, written exposure therapy was designed to create a more acceptable exposure-based treatment option for PTSD that is easily disseminated and implemented. Like the promising trauma-focused CBT interventions for PTSD prevention, it is also exposure-based. In light of these qualities, written exposure therapy thus may be ideally suited for reducing PTSD symptoms in non-treatment seeking survivors of acute cardiovascular events. Key differences between written exposure therapy and other CBT approaches to treating PTSD include a lower frequency of sessions (~5) and no homework requirement, resulting in higher treatment completion compared to a more rigorous exposure-based therapy approach. Other advantages of written exposure therapy are that it requires a lower level of training from clinicians and less clinician time, which could facilitate dissemination.
- Conditions
- Acute Coronary Syndrome, TIA, Stroke, Cardiac Arrest, PTSD
- Being tested
- Written Exposure Therapy
- Medical subject headings
- Acute Coronary Syndrome, Stroke, Heart Arrest, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Exposure TherapyBehavioural
Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.
| Study group | Role | What they receive |
|---|---|---|
| Early Psychological Intervention | Active comparator | Those assigned to Early Psychological Intervention will receive Written Exposure Therapy, a 5 session treatment in which participants write about their trauma event in a specified manner. Receives: Behavioral: Written Exposure Therapy |
| Usual care | No intervention | Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist - Stressor Specific (PCL-S) Score
This is to measure PTSD symptoms due to the index cardiovascular event. The PCL-S is self-report measure of the symptoms of PTSD. Respondents rate how much they were bothered by 20 symptoms, each rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely), such that total scores range from 0-80. The PCL-S (specific stressor) asks respondents about symptoms in relation to an identified stressful experience. The PCL-S aims to link symptom endorsements to the index cardiovascular event
Measured: 1 month after hospital discharge
Secondary outcomes (4)
Number of Subjects Completing the Written Exposure Therapy
This is to measure the feasibility of the therapy - completion to all 5 sessions among participants assigned to the intervention group
Measured: Approximately 1 month after hospital discharge
Adherent to Cardiovascular Medications
This is measured by the scoring from the Dose-Nonadherence questionnaire (3-items). Participants were categorized as adherent if they reported "none of the time" on all 3 items. Participants were categorized as nonadherent if they reported "at least some of the time" on any of the 3 items.
Measured: Approximately 1 month after hospital discharge
PHQ-8 Score
This is to measure change in depressive symptoms. The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies. Scores range from 0 - 24 and a score of 10 or greater is consistent with at least moderate depressive symptoms.
Measured: Baseline, 1 month after hospital discharge
Short Form Health Survey Version 2.0 (SF-12v2) Score
This is to measure quality of life. A health survey that uses 12 questions to measure functional health and well-being from the patient's point of view.
This measure was not collected at 6-months in any participants due to the study being terminated early.
Measured: Approximately 6 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Aug 2018
- Primary completion14 Aug 2019
- Study completion31 Dec 2019
Why it stopped: Halted Prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for PTSD
- Responsible party
- Principal investigator, Ian Kronish, Columbia University
- Investigators
- Ian Kronish, MD, Study director, Associate Professor of Medicine, Dept of Med Beh Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605693
- Sponsor's protocol ID
- AAAR7350-Q4612-R8497 substudy
- Status last verified
- Aug 2020
- First submitted
- 20 Jul 2018
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available upon request to the study prinicipal investigator.
Publications
Sloan DM, Marx BP, Lee DJ, Resick PA. A Brief Exposure-Based Treatment vs Cognitive Processing Therapy for Posttraumatic Stress Disorder: A Randomized Noninferiority Clinical Trial. JAMA Psychiatry. 2018 Mar 1;75(3):233-239. doi: 10.1001/jamapsychiatry.2017.4249.
PubMed 29344631
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Written Exposure Therapy to Prevent PTSD in Survivors of Acute Cardiovascular Events: A Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03605693
- Acronym / sponsor ID
- AAAR7350-Q4612-R8497 substudy
- Conditions
- Acute Coronary Syndrome, TIA, Stroke, Cardiac Arrest, PTSD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted Prematurely
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Center for PTSD
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 14 Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Posted 26 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of this project is to determine the feasibility of conducting a randomized clinical trial that compares written exposure therapy with usual care among patients at risk for cardiovascular event-induced PTSD.
Patients hospitalized with acute cardiovascular events, including strokes, heart attacks, and cardiac arrest are at risk of developing post-traumatic stress disorder (PTSD) due to the trauma of the acute medical event. The goal of this study is to test the feasibility of conducting a randomized trial involving a psychological intervention to prevent the development of PTSD symptoms in patients at risk for PTSD. Patients who are admitted with these acute cardiovascular events will first be screened for PTSD risk factors while in-hospital after the index event. These risk factors will include elevated threat perceptions at the time of presentation to the hospital or early symptoms of PTSD due to the cardiovascular event. Patients at elevated risk for PTSD will then be randomized to the intervention group or usual care. Those assigned to the intervention will participate in 5 sessions of written exposure therapy in which they are asked to write about the experience of their cardiovascular event with guidance from a trained study clinician. At 1 month after discharge, all patients will be contacted by phone to complete a questionnaire that assesses PTSD symptoms related to the cardiovascular event. Descriptive statistics will be used to understand the feasibility of testing the written exposure therapy intervention as part of a larger, fully powered clinical trial.
Detailed description
Experiencing a life threatening cardiovascular event, such as a stroke, transient ischemic attack (TIA), acute coronary syndrome (ACS), or cardiac arrest has been found to be associated with PTSD symptoms in up to 1 in 3 survivors. Patients with elevated PTSD symptoms are at risk for lower medication adherence, increased readmissions, recurrent cardiovascular events, and worsened quality of life. Risk for recurrent cardiovascular events is especially high in the initial weeks after acute cardiovascular events, and existing epidemiological data suggest that PTSD symptoms increase this risk. Thus, intervening early to prevent PTSD symptoms prior to waiting the full one or more months to make a PTSD diagnosis may provide new opportunities for offsetting cardiovascular disease (CVD) risk. Despite these adverse consequence of cardiovascular event-induced PTSD, these patients are not currently being systematically screened or treated to prevent PTSD symptoms, in part because there is no evidence assessing the effect of early interventions in this patient population.
A growing number of studies have been evaluating early interventions after trauma to prevent PTSD. While there is no gold-standard intervention, psychological interventions grounded in trauma-focused, cognitive behavioral therapy (CBT) have shown promise in some populations. For example, compared to a supportive counseling control condition, CBT has been found to reduce PTSD symptom severity and incidence in individuals with acute stress disorder (ASD), an early manifestation of posttraumatic stress, detected within the first month of a traumatic event. Preliminary research suggests that an exposure-based CBT intervention delivered in the immediate aftermath of trauma for individuals meeting Criterion A of a Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) PTSD diagnosis may also hold promise for PTSD prevention. Acute cardiovascular events such as stroke and ACS as the source of trauma are inherently different from other forms of stressors that commonly lead to PTSD. As opposed to an external and past traumatic threat (e.g., combat, physical/emotional abuse), these events can represent an ongoing internal somatic threat. Accordingly, treatments for preventing PTSD such as the trauma-focused CBT interventions discussed above need to be formally evaluated in this distinct patient population before generalizing the findings from other patient populations. In particular, the willingness to engage in therapies to prevent or reduce PTSD symptoms may differ in this patient population. Few of these patients are actively seeking treatment. Many may not be aware of potential psychological symptoms that can begin or worsen after these events and may not perceive their psychological symptoms to be problematic. Hence, the acceptability of psychological interventions is particularly relevant in this patient population.
Written exposure therapy represents a promising intervention to prevent PTSD after cardiovascular events. Written exposure therapy is a brief exposure-based therapy, founded on the principles of Pennebaker and Beale's written disclosure procedure. The treatment protocol consists of 5 sessions, each comprising 30 minutes of writing. In each session, participants are instructed to write about their memory of the traumatic event with particular attention to the felt emotions and the meaning of the event. The initial session also incorporates psychoeducation and review of the rationale for the intervention by a study clinician. Sessions end with therapists' discussing how the writing session went. The rationale behind this exposure therapy is that there is a significant habituation of emotional reactivity to reminders of the traumatic event over repeated writing sessions. Consistent with this rationale, research suggests that these exposure writing sessions are associated with greater initial emotional and physiological reactivity and greater habituation of these responses over time compared to a control writing condition. A recent study showed that this brief psychotherapy approach was non-inferior to a more extensive CBT approach (cognitive processing therapy) for reducing PTSD symptoms in adults with PTSD. Written exposure therapy has also been shown to be effective at lowering PTSD symptoms in patients with motor vehicle accident-induced PTSD.
In contrast with more standard CBT interventions, written exposure therapy was designed to create a more acceptable exposure-based treatment option for PTSD that is easily disseminated and implemented. Like the promising trauma-focused CBT interventions for PTSD prevention, it is also exposure-based. In light of these qualities, written exposure therapy thus may be ideally suited for reducing PTSD symptoms in non-treatment seeking survivors of acute cardiovascular events. Key differences between written exposure therapy and other CBT approaches to treating PTSD include a lower frequency of sessions (~5) and no homework requirement, resulting in higher treatment completion compared to a more rigorous exposure-based therapy approach. Other advantages of written exposure therapy are that it requires a lower level of training from clinicians and less clinician time, which could facilitate dissemination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Psychological Intervention | Active comparator | Behavioral: Written Exposure TherapyThose assigned to Early Psychological Intervention will receive Written Exposure Therapy, a 5 session treatment in which participants write about their trauma event in a specified manner. |
| Usual care | No intervention | –Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized with acute stroke, TIA, ACS, or cardiac arrest
- Enrolled in REACH-stroke, PHS, or REACH-cardiac arrest observational cohort studies
- Elevated ASD symptoms (ASD score >=28) and/or elevated threat perceptions during index hospitalization (ED threat score >=12)
Key exclusion criteria (2 listed)
- Unavailable for follow-up for written exposure therapy sessions
- Unable to read and write in English
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 |
|---|---|---|
| Written Exposure TherapyWritten exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner. | Behavioural | Early Psychological Intervention |
Primary outcome
PTSD Checklist - Stressor Specific (PCL-S) Score
Time frame: 1 month after hospital discharge
This is to measure PTSD symptoms due to the index cardiovascular event. The PCL-S is self-report measure of the symptoms of PTSD. Respondents rate how much they were bothered by 20 symptoms, each rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely), such that total scores range from 0-80. The PCL-S (specific stressor) asks respondents about symptoms in relation to an identified stressful experience. The PCL-S aims to link symptom endorsements to the index cardiovascular event
4 secondary outcomes
Number of Subjects Completing the Written Exposure Therapy
Time frame: Approximately 1 month after hospital discharge
Adherent to Cardiovascular Medications
Time frame: Approximately 1 month after hospital discharge
PHQ-8 Score
Time frame: Baseline, 1 month after hospital discharge
Short Form Health Survey Version 2.0 (SF-12v2) Score
Time frame: Approximately 6 months after hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29344631Sloan DM, Marx BP, Lee DJ, Resick PA. A Brief Exposure-Based Treatment vs Cognitive Processing Therapy for Posttraumatic Stress Disorder: A Randomized Noninferiority Clinical Trial. JAMA Psychiatry. 2018 Mar 1;75(3):233-239. doi: 10.1001/jamapsychiatry.2017.4249.
- Individual participant dataSharing planned: Yes. De-identified data will be made available upon request to the study prinicipal investigator.
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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. This study is not recruiting at the moment.
Ian Kronish, MD study director
Associate Professor of Medicine, Dept of Med Beh Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Exposure Therapy in people with Acute Coronary Syndrome and TIA, 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 16 Sep 2020. 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?
Yes. Results are posted in the registry (first posted 26 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist - Stressor Specific (PCL-S) Score (time frame: 1 month after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03605693, which also lists 1 linked publication.
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 16 Sep 2020.