NCT04983680

Remote-delivered MBCT for SCAD Survivors

Completed Phase 1 Results posted Last updated 19 September 2024

What this trial tests

Phase 1 trial testing MBCT in Acute Coronary Syndrome in 19 participants. Completed in 4 June 2022.

Timeline

4 November 2021

Primary endpoint
4 June 2022

4 June 2022

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	4 November 2021
Primary completion	4 June 2022
Estimated completion	4 June 2022
Sites	1 location across United States

Drugs / interventions tested

• MBCT

Conditions studied

• Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →
• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• Anxiety — all drugs for Anxiety →
• Sleep — all drugs for Sleep →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Acute Coronary Syndrome or Coronary Artery Disease. 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.

Feasibility of Enrollment: Percent of Participants Enrolled Primary · 7 months

Feasibility will be assessed by \>70% of eligible patients enroll

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	19

Feasibility of Retention: Percent of Enrolled Participants Retained at Post-intervention Primary · 7 months

Feasibility of retention will be assessed by \> 70% of participants completing the post-intervention survey

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	12

Feasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Pre-intervention Primary · 7 months

Feasibility of daily diary completion will be assessed by \>70% of participants completing daily diaries for 7 consecutive days at pre-intervention

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	13

Feasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Post-intervention Primary · 7 months

Feasibility of daily diary completion will be assessed by \>70% of participants completing daily diaries for 7 consecutive days at post-intervention

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	7

Feasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Pre-intervention Primary · 7 months

Feasibility of actigraphy use will be assessed by \>70% of participants completing actigraphy for 7 consecutive days at pre-intervention

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	18

Feasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Post-intervention Primary · 7 months

Feasibility of actigraphy use will be assessed by \>70% of participants completing actigraphy for 7 consecutive days at post-intervention

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	13

Feasibility of MBCT Intervention: Participant Attendance Rates Primary · 7 months

Feasibility of UpBeat-MBCT intervention will be assessed by \>70% of participants attending \>6/8 sessions

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	10

Feasibility of Videoconferencing Delivery: Percent of Sessions With Videoconferencing Problems Primary · 7 months

Feasibility of videoconferencing delivery will be assessed by \<20% of sessions missed due to videoconference problems

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	0

Intervention Acceptability: Plans to Use the Skills in the Future Primary · 7 months

Intervention acceptability will be assessed by \>70% plan to use the intervention skills in the future

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	11

Intervention Acceptability: Would Recommend the Program to Others Primary · 7 months

Intervention acceptability will be assessed by \>70% would recommend the program to others

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	10

Intervention Acceptability: Home Practice Completion Primary · 7 months

Acceptability of the UpBeat-MBCT intervention will be assessed by \>70% of participants completing home practice \>3days/week

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	9

Acceptability of Daily Diary Surveys: Ease of Completion Primary · 7 months

Acceptability of daily diaries will be assessed by ease of daily diary completion (1=not at all, 10=extremely). Mean acceptability rating \> 7.0 indicates acceptability

Group	Value	95% CI
Mindfulness-Based Cognitive Therapy	7.83	± 2.21

Adverse events — posted to ClinicalTrials.gov

Time frame: The data were collected over 7 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mindfulness-Based Cognitive Therapy

Serious: 0/19 (0%)

Deaths: 0/19

Other adverse events (1 terms — click to expand)

Reaction	System	Mindfulness-Based Cognitiv…
Adverse Event	Psychiatric disorders	—

Data from ClinicalTrials.gov NCT04983680 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications 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
2. Remotely delivered mindfulness-based cognitive therapy for spontaneous coronary artery dissection survivors.
   Luberto CM, Lopes M, Cloutier JG, Hall DL, et al · · 2025 · PMID 41120129 · DOI 10.1093/tbm/ibaf064