Remote-delivered MBCT for SCAD Survivors

NCT04983680 | Completed Phase 1 Results

• 2 other identifiers: 2021P001519P30AG064198
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Coronary Artery Disease; Anxiety; Sleep

Outcome Measures

Primary Outcomes (14)

• Feasibility of Enrollment: Percent of Participants Enrolled

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

  7 months

• Feasibility of Retention: Percent of Enrolled Participants Retained at Post-intervention

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

  7 months

• Feasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Pre-intervention

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

  7 months

• Feasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Post-intervention

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

  7 months

• Feasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Pre-intervention

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

  7 months

• Feasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Post-intervention

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

  7 months

• Feasibility of MBCT Intervention: Participant Attendance Rates

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

  7 months

• Feasibility of Videoconferencing Delivery: Percent of Sessions With Videoconferencing Problems

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

  7 months

• Intervention Acceptability: Plans to Use the Skills in the Future

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

  7 months

• Intervention Acceptability: Would Recommend the Program to Others

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

  7 months

• Intervention Acceptability: Home Practice Completion

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

  7 months

• Acceptability of Daily Diary Surveys: Ease of Completion

  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

  7 months

• Acceptability of Daily Diary Surveys: Level of Survey Interference

  Acceptability of daily diaries will be assessed by level of survey interference in daily life (1=not at all, 10=extremely, M\<2.0)

  7 months

• Acceptability of Actigraphy

  Acceptability of actigraphy will be assessed by ratings of ease of actigraphy completion (1=not at all, 10 =extremely, M\>7.0)

  7 months

Secondary Outcomes (10)

• Fear of Recurrence

  7 months

• Cognitive De-centering

  7 months

• Distress Tolerance

  7 months

• Attention Regulation

  7 months

• Non-judgmental Body Awareness

  7 Months

Study Arms (1)

Mindfulness-Based Cognitive Therapy

EXPERIMENTAL

Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week group intervention (1.5-hour weekly sessions) that combines cognitive-behavioral therapy and mindfulness training to treat emotional problems.

Behavioral: MBCT

Interventions

MBCT BEHAVIORAL

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.

Mindfulness-Based Cognitive Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Mongan Institute: Health Policy Research Center

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Luberto CM, Lopes M, Cloutier JG, Hall DL, Wood M, Schuman-Olivier Z, Hoeppner BB, Park ER. Remotely delivered mindfulness-based cognitive therapy for spontaneous coronary artery dissection survivors. Transl Behav Med. 2025 Jan 16;15(1):ibaf064. doi: 10.1093/tbm/ibaf064.

  PMID: 41120129 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease; Anxiety Disorders

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Mental Disorders

Results Point of Contact

• Title: Dr. Christina Luberto
• Organization: Massachusetts General Hospital/Harvard Medical School

cluberto@mgh.harvard.edu

617-643-9453

Study Officials

• Christina M Luberto, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 30, 2021
• Study Start: November 4, 2021
• Primary Completion: June 4, 2022
• Study Completion: June 4, 2022
• Last Updated: September 19, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)