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

Written Exposure Therapy to Prevent PTSD in Survivors of Acute Cardiovascular Events: A Pilot Randomized Clinical Trial

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03605693
Enrollment
10
Registered
2018-07-30
Start date
2018-08-01
Completion date
2019-12-31
Last updated
2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Cardiac Arrest, PTSD, Stroke, TIA

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.

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.

Interventions

BEHAVIORALWritten Exposure Therapy

Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.

Sponsors

National Center for PTSD
CollaboratorFED
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcomes assessors that assess PTSD symptoms 1 month after discharge (primary outcome) will be blinded to treatment assignment.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
PTSD Checklist - Stressor Specific (PCL-S) Score1 month after hospital dischargeThis 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

MeasureTime frameDescription
Number of Subjects Completing the Written Exposure TherapyApproximately 1 month after hospital dischargeThis is to measure the feasibility of the therapy - completion to all 5 sessions among participants assigned to the intervention group
Adherent to Cardiovascular MedicationsApproximately 1 month after hospital dischargeThis 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.
PHQ-8 ScoreBaseline, 1 month after hospital dischargeThis 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.
Short Form Health Survey Version 2.0 (SF-12v2) ScoreApproximately 6 months after hospital dischargeThis 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Written Exposure Therapy: Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.
5
Usual Care
Those assigned to usual care will complete study assessments but will not be referred to any psychological treatment
5
Total10

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up40
Overall StudyPhysician Decision10

Baseline characteristics

CharacteristicEarly Psychological InterventionUsual CareTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants2 Participants2 Participants
Age, Categorical
Between 18 and 65 years
5 Participants3 Participants8 Participants
Age, Continuous49.60 years
STANDARD_DEVIATION 13.15
52.20 years
STANDARD_DEVIATION 27.67
50.90 years
STANDARD_DEVIATION 20.47
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants1 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants4 Participants7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
3 Participants2 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants2 Participants
Race (NIH/OMB)
White
0 Participants2 Participants2 Participants
Region of Enrollment
United States
5 participants5 participants10 participants
Sex: Female, Male
Female
3 Participants1 Participants4 Participants
Sex: Female, Male
Male
2 Participants4 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 50 / 5
other
Total, other adverse events
0 / 50 / 5
serious
Total, serious adverse events
0 / 50 / 5

Outcome results

Primary

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

Time frame: 1 month after hospital discharge

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

ArmMeasureValue (MEAN)
Early Psychological InterventionPTSD Checklist - Stressor Specific (PCL-S) Score14.0 score on a scale
Usual CarePTSD Checklist - Stressor Specific (PCL-S) Score13.5 score on a scale
Secondary

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.

Time frame: Approximately 1 month after hospital discharge

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Early Psychological InterventionAdherent to Cardiovascular Medications1 Participants
Usual CareAdherent to Cardiovascular Medications1 Participants
Secondary

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

Time frame: Approximately 1 month after hospital discharge

Population: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Early Psychological InterventionNumber of Subjects Completing the Written Exposure Therapy0 Participants
Usual CareNumber of Subjects Completing the Written Exposure Therapy0 Participants
Secondary

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.

Time frame: Baseline, 1 month after hospital discharge

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

ArmMeasureValue (MEAN)
Early Psychological InterventionPHQ-8 Score0 score on a scale
Usual CarePHQ-8 Score6.5 score on a scale
Secondary

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.

Time frame: Approximately 6 months after hospital discharge

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

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026