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

NCT03605693 | Terminated Results

• 1 other identifier: AAAR7350-Q4612-R8497 substudy
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  1 month after hospital discharge

Secondary Outcomes (4)

• Number of Subjects Completing the Written Exposure Therapy

  Approximately 1 month after hospital discharge

• Adherent to Cardiovascular Medications

  Approximately 1 month after hospital discharge

• PHQ-8 Score

  Baseline, 1 month after hospital discharge

• Short Form Health Survey Version 2.0 (SF-12v2) Score

  Approximately 6 months after hospital discharge

Study Arms (2)

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.

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

Interventions

Written Exposure Therapy BEHAVIORAL

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

Early Psychological Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Unavailable for follow-up for written exposure therapy sessions
• Unable to read and write in English

Sponsors & Collaborators

• Columbia University: lead
• National Center for PTSD: collaborator

Study Sites (1)

Center for Behavioral Cardiovascular Health

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 29344631 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Stroke; Heart Arrest; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Ian Kronish
• Organization: Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center

ik2293@columbia.edu

212-342-1335

Study Officials

• Ian Kronish, MD

  Associate Professor of Medicine, Dept of Med Beh Cardiology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors that assess PTSD symptoms 1 month after discharge (primary outcome) will be blinded to treatment assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Dept of Med Beh Cardiology

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 30, 2018
• Study Start: August 1, 2018
• Primary Completion: August 14, 2019
• Study Completion: December 31, 2019
• Last Updated: September 16, 2020
• Results First Posted: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available August 1, 2020, and will be available until August 1, 2025.
• Access Criteria: For whom: Researchers who provide a methodologically sound protocol. For what analyses: To achieve aims in the approved protocol.

Locations

US (1)