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

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ClinicalTrials.gov Identifier: NCT03605693
Recruitment Status : Active, not recruiting
First Posted : July 30, 2018
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
National Center for PTSD
Information provided by (Responsible Party):
Ian Kronish, Columbia University

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 Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
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 : August 1, 2018
Actual Primary Completion Date : August 14, 2019
Estimated Study Completion Date : December 31, 2019

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



Primary Outcome Measures :
  1. 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 a symptom on a 5-point scale ranging from 1 (not at all) to 5 (extremely). The PCL-S (specific) asks 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 [ Time Frame: 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. Adherence to cardiovascular medications [ Time Frame: Approximately 1 month after hospital discharge ]
    This is measured by the scoring from the voils adherence questionnaire (3-items).

  3. PHQ-8 score [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03605693


Locations
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United States, New York
Center for Behavioral Cardiovascular Health
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Center for PTSD
Investigators
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Study Director: Ian Kronish, MD Associate Professor of Medicine, Dept of Med Beh Cardiology

Publications:
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Responsible Party: Ian Kronish, Associate Professor of Medicine, Dept of Med Beh Cardiology, Columbia University
ClinicalTrials.gov Identifier: NCT03605693     History of Changes
Other Study ID Numbers: AAAR7350-Q4612-R8497 substudy
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases