NCT03605693

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

Terminated NA Results posted Last updated 16 September 2020

What this trial tests

NA trial testing Written Exposure Therapy in Acute Coronary Syndrome in 10 participants. Terminated before completion.

Timeline

1 August 2018

Primary endpoint
14 August 2019

31 December 2019

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	10
Start date	1 August 2018
Primary completion	14 August 2019
Estimated completion	31 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Written Exposure Therapy

Conditions studied

• Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →
• TIA — all drugs for TIA →
• Stroke — all drugs for Stroke →
• Cardiac Arrest — all drugs for Cardiac Arrest →

Sponsor

Columbia University

Who can join

18 and older, any sex, with Acute Coronary Syndrome or TIA. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

PTSD Checklist - Stressor Specific (PCL-S) Score Primary · 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

Group	Value	95% CI
Early Psychological Intervention	14.0	4 – 24
Usual Care	13.5	0 – 27

Number of Subjects Completing the Written Exposure Therapy Secondary · 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

Group	Value	95% CI
Early Psychological Intervention	0
Usual Care	0

Adherent to Cardiovascular Medications Secondary · 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.

Group	Value	95% CI
Early Psychological Intervention	1
Usual Care	1

PHQ-8 Score Secondary · 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.

Group	Value	95% CI
Early Psychological Intervention	0	0 – 0
Usual Care	6.5	0 – 13

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Mental Health-Acute Coronary Syndrome Continuum: Bidirectional Pathophysiological Links and Clinical Implications.
   Herlaș-Pop A, Radu AF, Radu A, Bungau GS, et al · · 2026 · PMID 41892853 · DOI 10.3390/medsci14010138