Early Psychological Intervention to Prevent Cardiovascular Event-Induced PTSD (REACH Sub-study)

• Sponsor: Columbia University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03605693
• Collaborator: National Center for PTSD (U.S. Fed)
• Enrollment: 10
• Location: 1
• Arms: 2
• Actual Duration (Months): 17
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome; TIA; Stroke; Cardiac Arrest; PTSD	Behavioral: Written Exposure Therapy	N/A

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

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcomes assessors that assess PTSD symptoms 1 month after discharge (primary outcome) will be blinded to treatment assignment.
• Primary Purpose: Prevention
• Official Title: Written Exposure Therapy to Prevent PTSD in Survivors of Acute Cardiovascular Events: A Pilot Randomized Clinical Trial
• Actual Study Start Date: Aug 1, 2018
• Actual Primary Completion Date: Aug 14, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Early Psychological Intervention 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.	Behavioral: Written Exposure Therapy; Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.
No Intervention: Usual care Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment

Outcome Measures

Primary Outcome Measures

1. PTSD Checklist - Stressor Specific (PCL-S) Score [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

Secondary Outcome Measures

1. Number of Subjects Completing the Written Exposure Therapy [Approximately 1 month after hospital discharge]

   This is to measure the feasibility of the therapy - completion to all 5 sessions among participants assigned to the intervention group

2. Adherent to Cardiovascular Medications [Approximately 1 month after hospital discharge]

   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.

3. PHQ-8 Score [Baseline, 1 month after hospital discharge]

   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.

4. Short Form Health Survey Version 2.0 (SF-12v2) Score [Approximately 6 months after hospital discharge]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Unavailable for follow-up for written exposure therapy sessions

• Unable to read and write in English

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Behavioral Cardiovascular Health	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University
• National Center for PTSD

Investigators

• Study Director: Ian Kronish, MD, Associate Professor of Medicine, Dept of Med Beh Cardiology

Study Documents (Full-Text)

• Study Protocol - Jul 10, 2020
• Statistical Analysis Plan - Jul 10, 2020

More Information

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.

• Responsible Party: Ian Kronish, Associate Professor of Medicine, Dept of Med Beh Cardiology, Columbia University
• ClinicalTrials.gov Identifier: NCT03605693
• Other Study ID Numbers: AAAR7350-Q4612-R8497 substudy
• First Posted: Jul 30, 2018
• Last Update Posted: Sep 16, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Coronary Syndrome

Study Results

Participant Flow

Arm/Group Title	Early Psychological Intervention	Usual Care
Arm/Group Description	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. Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.	Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
Period Title: Overall Study
STARTED	5	5
COMPLETED	0	5
NOT COMPLETED	5	0

Baseline Characteristics

Arm/Group Title	Early Psychological Intervention	Usual Care	Total
Arm/Group Description	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. Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.	Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment	Total of all reporting groups
Overall Participants	5	5	10
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 100%	3 60%	8 80%
>=65 years	0 0%	2 40%	2 20%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.60 (13.15)	52.20 (27.67)	50.90 (20.47)
Sex: Female, Male (Count of Participants)
Female	3 60%	1 20%	4 40%
Male	2 40%	4 80%	6 60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 40%	1 20%	3 30%
Not Hispanic or Latino	3 60%	4 80%	7 70%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 20%	0 0%	1 10%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 60%	2 40%	5 50%
White	0 0%	2 40%	2 20%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 20%	1 20%	2 20%
Region of Enrollment (participants) [Number]
United States	5 100%	5 100%	10 100%

Outcome Measures

1. Primary Outcome

Title	PTSD Checklist - Stressor Specific (PCL-S) Score
Description	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
Time Frame	1 month after hospital discharge

Outcome Measure Data

Analysis Population Description

Not all participants were able to be contacted for 1-month follow-up assessment.

Arm/Group Title	Early Psychological Intervention	Usual Care
Arm/Group Description	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. Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.	Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
Measure Participants	3	2
Mean (Full Range) [score on a scale]	14.0	13.5

2. Secondary Outcome

Title	Number of Subjects Completing the Written Exposure Therapy
Description	This is to measure the feasibility of the therapy - completion to all 5 sessions among participants assigned to the intervention group
Time Frame	Approximately 1 month after hospital discharge

Outcome Measure Data

Analysis Population Description

This outcome only applies to patients randomized to the Early Psychological Intervention. Data were not collected on this variable for patients randomized to usual care.

Arm/Group Title	Early Psychological Intervention	Usual Care
Arm/Group Description	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. Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.	Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
Measure Participants	5	0
Count of Participants [Participants]	0 0%	0 0%

3. Secondary Outcome

Title	Adherent to Cardiovascular Medications
Description	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.
Time Frame	Approximately 1 month after hospital discharge

Outcome Measure Data

Analysis Population Description

Not all participants completed the self-reported medication adherence questionnaire.

Arm/Group Title	Early Psychological Intervention	Usual Care
Arm/Group Description	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. Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.	Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
Measure Participants	1	1
Count of Participants [Participants]	1 20%	1 20%

4. Secondary Outcome

Title	PHQ-8 Score
Description	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.
Time Frame	Baseline, 1 month after hospital discharge

Outcome Measure Data

Analysis Population Description

Some participants were unable to be contacted at 1-month to complete this questionnaire.

Arm/Group Title	Early Psychological Intervention	Usual Care
Arm/Group Description	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. Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.	Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
Measure Participants	1	2
Mean (Full Range) [score on a scale]	0	6.5

5. Secondary Outcome

Title	Short Form Health Survey Version 2.0 (SF-12v2) Score
Description	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.
Time Frame	Approximately 6 months after hospital discharge

Outcome Measure Data

Analysis Population Description

0 patients were analyzed as 6-month data were not collected.

Arm/Group Title	Early Psychological Intervention	Usual Care
Arm/Group Description	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. Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.	Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
Measure Participants	0	0

Adverse Events

Time Frame	6 months
Arm/Group Title	Early Psychological Intervention		Usual Care
Arm/Group Description	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. Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.		Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
All Cause Mortality
	Early Psychological Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)
Serious Adverse Events
	Early Psychological Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Early Psychological Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.