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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
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.
Mongan Institute: Health Policy Research Center
Boston, Massachusetts, United States
Feasibility of Enrollment: Percent of Participants Enrolled
Feasibility will be assessed by \>70% of eligible patients enroll
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 7 months
Intervention Acceptability: Would Recommend the Program to Others
Intervention acceptability will be assessed by \>70% would recommend the program to others
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 7 months
Fear of Recurrence
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. This study used a 5 item version of the ASC, thus the scores range from 5 (lower fear of reoccurrence) to 20 (higher fear of reoccurrence). The 5 item version has two subscales: health worry, cardiac worry. Scores from each subscale are summed to achieve the final score.
Time frame: 7 months
Cognitive De-centering
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). Each item is scored on a Likert scale from 1 (never) to 5 (all of the time); the total minimum score is 11 while the maximum score is 55. Higher scores indicate greater cognitive decentering (better outcomes), while lower scores indicate less cognitive de-centering (worse outcome)
Time frame: 7 months
Distress Tolerance
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. The DTS is 15 item measure where each item is scores from 1 (strongly agree) to 5 (strongly disagree). Lower scores (minimum = 1) indicate lower distress tolerance and worse outcomes. Higher scores (maximum = 5) indicate higher distress tolerance and better outcomes.
Time frame: 7 months
Attention Regulation
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. Items are scored on a scale 1 (Rarely/Not at all) to 4 (Almost Always). Lower scores (minimum = 1) reflect lower trait mindfulness (worse outcome) whereas higher scores (maximum = 40) indicate higher trait mindfulness (better outcome)
Time frame: 7 months
Non-judgmental Body Awareness
The body trusting subscale of 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. The minimum score on the subscale is 0 while the maximum is 10. Scores of 10 indicate higher body trusting (better outcome). Scores of 0 indicate lower body trusting (worse outcome).
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Time frame: 7 Months
Interoceptive Bias
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. The maximum score is 280, indicating high body vigilance and worse outcomes, while the minimum score is 0,indicating low body vigilance and better outcomes.
Time frame: 7 months
Intolerance of Uncertainty
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. The maximum score is 60 which indicates high intolerance of uncertainty and worse outcomes. The minimum score is 12 which indicates low intolerance of uncertainty and better outcomes. Each item is scored on a scale from 1 (not at all characteristic of me) to 5 (entirely characteristic of me).
Time frame: 7 months
Cardiac Anxiety
Four items from the physical concerns subscale of the Anxiety Sensitivity Index 3 will be used to assess cardiac anxiety levels before and after the intervention. Items are scored on a scale from 0 (very little) to 4 (very much). The minimum possible score is 0, indicating low anxiety sensitivity and better outcomes. The maximum possible score is 16, indicating high anxiety sensitivity and worse outcomes.
Time frame: 7 months
Self-reported Sleep Outcomes
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 and will be included in the sleep diaries.
Time frame: 3 months
Self-reported Physical Activity
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.
Time frame: 3 months