Phase 1 Completed N=19 Treatment

Remote-delivered MBCT for SCAD Survivors

Coronary Artery Disease · Anxiety · Sleep

Source: ClinicalTrials.gov NCT04983680 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2024

Primary outcomePrimary: Feasibility of Enrollment: Percent of Participants Enrolled — 19 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility of Enrollment: Percent of Participants Enrolled	19	—
PRIMARY Feasibility of Retention: Percent of Enrolled Participants Retained at Post-intervention	12	—
PRIMARY Feasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Pre-intervention	13	—
PRIMARY Feasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Post-intervention	7	—
PRIMARY Feasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Pre-intervention	18	—
PRIMARY Feasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Post-intervention	13	—
PRIMARY Feasibility of MBCT Intervention: Participant Attendance Rates	10	—
PRIMARY Feasibility of Videoconferencing Delivery: Percent of Sessions With Videoconferencing Problems	—	—
PRIMARY Intervention Acceptability: Plans to Use the Skills in the Future	11	—
PRIMARY Intervention Acceptability: Would Recommend the Program to Others	10	—
PRIMARY Intervention Acceptability: Home Practice Completion	9	—
PRIMARY Acceptability of Daily Diary Surveys: Ease of Completion	7.83	—
PRIMARY Acceptability of Daily Diary Surveys: Level of Survey Interference	3.0	—
PRIMARY Acceptability of Actigraphy	8.67	—
SECONDARY Fear of Recurrence	13.33; 11.33	—
SECONDARY Cognitive De-centering	32.91; 38.18	—
SECONDARY Distress Tolerance	3.19; 3.39	—
SECONDARY Attention Regulation	31.58; 32.58	—
SECONDARY Non-judgmental Body Awareness	8.0; 8.7	—
SECONDARY Interoceptive Bias	18.25; 15.08	—
SECONDARY Intolerance of Uncertainty	33.36; 27.63	—
SECONDARY Cardiac Anxiety	9.42; 6.83	—
SECONDARY Self-reported Sleep Outcomes	1.83; 1.63	—
SECONDARY Self-reported Physical Activity	33.46; 59.50	—

Eligibility Criteria

Inclusion Criteria

Age >18 years
Cardiologist-confirmed diagnosis of SCAD in the past 1-12 months
English-speaking and reading
Internet access (via computer or mobile device).

Exclusion Criteria

Terminal illness with life expectancy <1 year
Severe mental illness requiring urgent psychiatric intervention (e.g., active suicidal ideation) or past-year psychiatric hospitalization)
Significant cognitive impairment preventing informed consent determined by study staff or medical record review (e.g., medical history of cognitive impairment)
Deemed unable to complete research procedures (e.g., group sessions or surveys) per clinical judgment of study staff
Unavailable for intervention sessions (e.g., schedule conflicts)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04983680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.