NCT04983680

Remote-delivered MBCT for SCAD Survivors

Remote-delivered Mindfulness-Based Cognitive Therapy to Target Fear of Recurrence Among SCAD Survivors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Spontaneous coronary artery dissection (SCAD) is an important cause of cardiac events, primarily affecting young healthy women with no cardiovascular risk factors. The 10-year recurrence rate is 30%, but SCAD recurrence cannot be predicted. Approximately half of SCAD survivors struggle with significant anxiety and fear of recurrence (FOR), which contributes to poor sleep and physical inactivity and, thereby, increased risk of recurrence. Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week group intervention with evidence to improve FOR and health behaviors (sleep, physical activity), through psychological mechanisms that directly target key FOR processes (interoceptive bias, intolerance of uncertainty). I adapted MBCT to target FOR, sleep, and physical activity in cardiac event survivors via group videoconferencing delivery (UpBeat-MBCT), however this intervention has not yet been targeted to SCAD survivors. I propose an open pilot trial to test the feasibility, acceptability, and changes in psychological and behavioral health variables in SCAD survivors participating in UpBeat-MBCT (N=16). Participants will be recruited from the MGH SCAD Program and asked to complete self-report surveys and actigraphy before and after the intervention. The primary outcomes are feasibility and acceptability of the intervention and research procedures. Exploratory outcomes are changes in psychological and behavioral variables and their inter-correlations. This project would be the first and only behavioral intervention for SCAD survivors and would provide preliminary data for an NIH Stage II efficacy trial to develop an accessible and efficacious intervention for a vulnerable group of SCAD survivors, with generalizability to survivors of other cardiac events.

Conditions

• Acute Coronary Syndrome
• Coronary Artery Disease
• Anxiety
• Sleep

Interventions

Type	Name	Description
BEHAVIORAL	MBCT	Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week group intervention (1.5-hour weekly sessions) that combines cognitive-behavioral therapy and mindfulness training. In this study, MBCT has been adapted to include education about cardiac health and fear of recurrence, and the intervention is delivered remotely via synchronous group videoconference. There is 15-20 minutes of daily mindfulness practice between sessions. Participants are provided a home practice record form and asked to submit the completed form to study staff each week.

Timeline

• Start date: 2021-11-04
• Primary completion: 2022-06-04
• Completion: 2022-06-04
• First posted: 2021-07-30
• Last updated: 2024-09-19
• Results posted: 2024-05-16

Locations

1 site across 1 country: United States