Remote-delivered MBCT for SCAD Survivors

• ClinicalTrials.gov Identifier: NCT04983680
• Recruitment Status: Completed
• First Posted: July 30, 2021
• Last Update Posted: March 15, 2023
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Christina Luberto, Massachusetts General Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Coronary Syndrome; Coronary Artery Disease; Anxiety; Sleep	Behavioral: MBCT	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Remote-delivered Mindfulness-Based Cognitive Therapy to Target Fear of Recurrence Among SCAD Survivors
• Actual Study Start Date: November 4, 2021
• Actual Primary Completion Date: June 7, 2022
• Actual Study Completion Date: June 7, 2022

Arms and Interventions

Arm

Intervention/treatment

Experimental: Mindfulness-Based Cognitive Therapy; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Feasibility of enrollment: percent of participants enrolled [ Time Frame: 1 year ]
   Feasibility will be assessed by >70% of eligible patients enroll and <20% ineligible due to each criterion
2. Feasibility of retention: percent of enrolled participants retained at post-intervention [ Time Frame: 1 year ]
   Feasibility of retention will be assessed by <20% participant attrition
3. Feasibility of survey completion: percent of participants who complete the study surveys [ Time Frame: 1 year ]
   Feasibility of survey completion will be assessed by >70 pre-intervention and post-intervention surveys completed, >70% daily diaries completed for 7 consecutive days, <20% missing data on daily diaries
4. Feasibility of actigraphy use: percent of participants who adhere to actigraphy procedures [ Time Frame: 1 year ]
   Feasibility of actigraphy use will be assessed by >70% completed for 7 consecutive days
5. Feasibility of MBCT intervention: participant attendance rates [ Time Frame: 1 year ]
   Feasibility of UpBeat-MBCT intervention components will be assessed by >70% session attendance
6. Feasibility of videoconferencing delivery: percent of sessions with videoconferencing problems [ Time Frame: 1 year ]
   Feasibility of videoconferencing delivery will be assessed by <20% of sessions missed due to videoconference problems and <20% connections dropped during session
7. Acceptability of study surveys [ Time Frame: 1 year ]
   Acceptability of surveys and daily diaries will be assessed by ease of survey completion (1=not at all, 10=extremely, M<7.0) and level of survey interference in daily life (1=not at all, 10=extremely, M<2.0)
8. Acceptability of actigraphy [ Time Frame: 1 year ]
   Acceptability of actigraphy will be assessed by ratings of ease of actigraphy completion (1=not at all, 10 =extremely, M>7.0)
9. Intervention home practice completion [ Time Frame: 1 year ]
   Acceptability of the UpBeat-MBCT intervention will be assessed by >70% of home practice completed <3days/week
10. Intervention content acceptability [ Time Frame: 1 year ]
    Intervention acceptability will be assessed by >70% plan to use the skills and would recommend the program to others
11. Intervention perspectives [ Time Frame: 1 year ]
    Intervention perspectives will be assessed by likes, dislikes, and suggestions for program improvement reported in the exit interview

Secondary Outcome Measures :

1. Non-judgmental body awareness [ Time Frame: 1 year ]
   The multidimensional assessment of interoceptive awareness, a validated self-report survey, will be used to explore levels of non-judgmental body awareness before and after the intervention, including daily diaries
2. Attention regulation [ Time Frame: 1 year ]
   The Cognitive Affective Mindfulness Scale-Revised, a validated self-report survey, will be used to explore levels of trait mindfulness before and after the intervention, including daily diaries
3. Cognitive de-centering [ Time Frame: 1 year ]
   The Experiences Questionnaire, a validated self-report survey, will be used to explore levels of trait cognitive de-centering before and after the intervention (i.e., the ability to notice mental events as transient objects separate from the self), including daily diaries
4. Distress tolerance [ Time Frame: 1 year ]
   The Distress Tolerance Scale, a validated self-report survey, will be used to explore levels of the ability to withstand negative emotional states before and after the intervention, including daily diaries
5. Interoceptive bias [ Time Frame: 1 year ]
   The Body Vigilance Scale, a validated self-report survey, will be used to explore attentional bias, hypervigilance, and sensitivity toward physical sensations around the chest before and after the intervention, including daily diaries
6. Intolerance of uncertainty [ Time Frame: 1 year ]
   The Intolerance of Uncertainty Scale-12, a validated self-report survey, will be used to explore the ability to tolerate uncertainty before and after the intervention, including daily diaries
7. Fear of recurrence [ Time Frame: 1 year ]
   The Assessment of Survivor Concerns, a validated self-report survey, will be used to explore the severity of fears of recurrent cardiac events before and after the intervention, including daily diaries
8. Self-reported sleep outcomes [ Time Frame: 1 year ]
   Sleep duration, sleep efficiency, and sleep onset latency will be assessed by self-report survey via the Consensus Sleep Diary before and after the intervention, including daily diaries
9. Actigraphy sleep outcomes [ Time Frame: 1 year ]
   Sleep duration, sleep efficiency, and sleep onset latency will be assessed via Actigraphy (7 consecutive days before and after the intervention)
10. Self-reported physical activity [ Time Frame: 1 year ]
    Moderate-vigorous physical activity engagement will be assessed by self-report survey via the Physical Activity Vital sign before and after the intervention, including daily diaries
11. Actigraphy physical activity outcomes [ Time Frame: 1 year ]
    Moderate-vigorous physical activity, total steps, and sedentary time will be assessed via Actigraphy (7 consecutive days)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United States, Massachusetts

Mongan Institute: Health Policy Research Center

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

• Principal Investigator: Christina M Luberto, PhD; Massachusetts General Hospital

More Information

• Responsible Party: Christina Luberto, Assistant Professor of Psychology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04983680
• Other Study ID Numbers: 2021P001519
• First Posted: July 30, 2021
• Last Update Posted: March 15, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Coronary Artery Disease; Acute Coronary Syndrome; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases