Clinical trial NCT04983680: Remote-delivered MBCT for SCAD Survivors
Official title: Remote-delivered Mindfulness-Based Cognitive Therapy to Target Fear of Recurrence Among SCAD Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Coronary Syndrome
Coronary Artery Disease
Anxiety
Sleep
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-07-30
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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)

Primary outcomes:
measure: Feasibility of Enrollment: Percent of Participants Enrolled
timeFrame: 7 months
measure: Feasibility of Retention: Percent of Enrolled Participants Retained at Post-intervention
timeFrame: 7 months
measure: Feasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Pre-intervention
timeFrame: 7 months
measure: Feasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Post-intervention
timeFrame: 7 months
measure: Feasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Pre-intervention
timeFrame: 7 months
measure: Feasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Post-intervention
timeFrame: 7 months
measure: Feasibility of MBCT Intervention: Participant Attendance Rates
timeFrame: 7 months
measure: Feasibility of Videoconferencing Delivery: Percent of Sessions With Videoconferencing Problems
timeFrame: 7 months
measure: Intervention Acceptability: Plans to Use the Skills in the Future
timeFrame: 7 months
measure: Intervention Acceptability: Would Recommend the Program to Others
timeFrame: 7 months
measure: Intervention Acceptability: Home Practice Completion
timeFrame: 7 months
measure: Acceptability of Daily Diary Surveys: Ease of Completion
timeFrame: 7 months
measure: Acceptability of Daily Diary Surveys: Level of Survey Interference
timeFrame: 7 months
measure: Acceptability of Actigraphy
timeFrame: 7 months
Secondary outcomes:
measure: Fear of Recurrence
timeFrame: 7 months
measure: Cognitive De-centering
timeFrame: 7 months
measure: Distress Tolerance
timeFrame: 7 months
measure: Attention Regulation
timeFrame: 7 months
measure: Non-judgmental Body Awareness
timeFrame: 7 Months
measure: Interoceptive Bias
timeFrame: 7 months
measure: Intolerance of Uncertainty
timeFrame: 7 months
measure: Cardiac Anxiety
timeFrame: 7 months
measure: Self-reported Sleep Outcomes
timeFrame: 3 months
measure: Self-reported Physical Activity
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mongan Institute: Health Policy Research Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Christina M Luberto, PhD
role: PRINCIPAL_INVESTIGATOR
References: