Trial Outcomes & Findings for Remote-delivered MBCT for SCAD Survivors (NCT NCT04983680)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

19 participants

Primary outcome timeframe

7 months

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	19
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The analysis population for gender is n=17 which differs from the overall sample (n=19) because two participants did not report their gender.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mindfulness-Based Cognitive Therapy n=19 Participants 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. 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.
Age, Continuous	50.68 years STANDARD_DEVIATION 9.46 • n=19 Participants
Sex: Female, Male Female	16 Participants n=17 Participants • The analysis population for gender is n=17 which differs from the overall sample (n=19) because two participants did not report their gender.
Sex: Female, Male Male	1 Participants n=17 Participants • The analysis population for gender is n=17 which differs from the overall sample (n=19) because two participants did not report their gender.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=19 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=19 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=19 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=19 Participants
Race (NIH/OMB) Asian	0 Participants n=19 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=19 Participants
Race (NIH/OMB) Black or African American	1 Participants n=19 Participants
Race (NIH/OMB) White	18 Participants n=19 Participants
Race (NIH/OMB) More than one race	0 Participants n=19 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=19 Participants
Time Since SCAD	22.74 months STANDARD_DEVIATION 4.24 • n=19 Participants

PRIMARY outcome

Timeframe: 7 months

Population: The number of participants analyzed for this variable (n=20) is higher than the number who started the trial (n=19), because one person who screened eligible refused to enroll.

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

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=20 Participants 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. 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.
Feasibility of Enrollment: Percent of Participants Enrolled	19 Participants

PRIMARY outcome

Timeframe: 7 months

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

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=19 Participants 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. 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.
Feasibility of Retention: Percent of Enrolled Participants Retained at Post-intervention	12 Participants

PRIMARY outcome

Timeframe: 7 months

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

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=19 Participants 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. 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.
Feasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Pre-intervention	13 Participants

PRIMARY outcome

Timeframe: 7 months

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

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=12 Participants 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. 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.
Feasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Post-intervention	7 Participants

PRIMARY outcome

Timeframe: 7 months

Population: Participants who received an actigraphy watch as part of the study. Note that although 19 participants were enrolled, only 18 received a watch and were included in actigraphy procedures because the study team only had 18 watches available.

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

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=18 Participants 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. 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.
Feasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Pre-intervention	18 Participants

PRIMARY outcome

Timeframe: 7 months

Population: Participants who received an actigraphy watch as part of the study. Note that although 19 participants were enrolled, only 18 received a watch and were included in actigraphy procedures because the study team only had 18 watches available.

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

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=18 Participants 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. 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.
Feasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Post-intervention	13 Participants

PRIMARY outcome

Timeframe: 7 months

Population: participants who enrolled in, and attended, group intervention sessions.

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

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=19 Participants 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. 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.
Feasibility of MBCT Intervention: Participant Attendance Rates	10 Participants

PRIMARY outcome

Timeframe: 7 months

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

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=16 Number of virtual sessions 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. 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.
Feasibility of Videoconferencing Delivery: Percent of Sessions With Videoconferencing Problems	0 Number of virtual sessions

PRIMARY outcome

Timeframe: 7 months

Population: Participants retained at post-intervention who answered this item on the post-survey

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

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=11 Participants 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. 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.
Intervention Acceptability: Plans to Use the Skills in the Future	11 Participants

PRIMARY outcome

Timeframe: 7 months

Population: Participants retained at post-intervention who answered this item on the post-survey

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

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=11 Participants 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. 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.
Intervention Acceptability: Would Recommend the Program to Others	10 Participants

PRIMARY outcome

Timeframe: 7 months

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

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=12 Participants 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. 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.
Intervention Acceptability: Home Practice Completion	9 Participants

PRIMARY outcome

Timeframe: 7 months

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

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=12 Participants 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. 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.
Acceptability of Daily Diary Surveys: Ease of Completion	7.83 score on a scale Standard Deviation 2.21

PRIMARY outcome

Timeframe: 7 months

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

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=12 Participants 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. 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.
Acceptability of Daily Diary Surveys: Level of Survey Interference	3.0 score on a scale Standard Deviation 2.59

PRIMARY outcome

Timeframe: 7 months

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

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=12 Participants 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. 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.
Acceptability of Actigraphy	8.67 score on a scale Standard Deviation 2.27

SECONDARY outcome

Timeframe: 7 months

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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=12 Participants 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. 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.
Fear of Recurrence Pre-intervention	13.33 score on a scale Standard Deviation 3.50
Fear of Recurrence Post-intervention	11.33 score on a scale Standard Deviation 3.85

SECONDARY outcome

Timeframe: 7 months

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)

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=11 Participants 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. 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.
Cognitive De-centering Pre-intervention	32.91 score on a scale Standard Deviation 10.00
Cognitive De-centering Post-intervention	38.18 score on a scale Standard Deviation 6.52

SECONDARY outcome

Timeframe: 7 months

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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=11 Participants 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. 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.
Distress Tolerance Pre-intervention	3.19 score on a scale Standard Deviation .94
Distress Tolerance Post-intervention	3.39 score on a scale Standard Deviation .76

SECONDARY outcome

Timeframe: 7 months

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)

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=12 Participants 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. 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.
Attention Regulation Pre-intervention	31.58 score on a scale Standard Deviation 8.74
Attention Regulation Post-intervention	32.58 score on a scale Standard Deviation 6.93

SECONDARY outcome

Timeframe: 7 Months

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).

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=10 Participants 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. 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.
Non-judgmental Body Awareness Pre-intervention	8.0 score on a scale Standard Deviation 5.54
Non-judgmental Body Awareness Post-intervention	8.7 score on a scale Standard Deviation 4.76

SECONDARY outcome

Timeframe: 7 months

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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=12 Participants 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. 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.
Interoceptive Bias Pre-intervention	18.25 score on a scale Standard Deviation 5.28
Interoceptive Bias Post-intervention	15.08 score on a scale Standard Deviation 5.14

SECONDARY outcome

Timeframe: 7 months

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).

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=11 Participants 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. 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.
Intolerance of Uncertainty Pre-intervention	33.36 score on a scale Standard Deviation 14.40
Intolerance of Uncertainty Post-intervention	27.63 score on a scale Standard Deviation 12.91

SECONDARY outcome

Timeframe: 7 months

Population: N=8 in post intervention due to incomplete surveys

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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=12 Participants 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. 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.
Cardiac Anxiety Pre-intervention	9.42 score on a scale Standard Deviation 4.21
Cardiac Anxiety Post-intervention	6.83 score on a scale Standard Deviation 4.61

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=12 Participants 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. 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.
Self-reported Sleep Outcomes Pre-Intervention	1.83 number of awakenings per night Standard Deviation 1.11
Self-reported Sleep Outcomes Post-Intervention	1.63 number of awakenings per night Standard Deviation 0.92

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Cognitive Therapy n=12 Participants 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. 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.
Self-reported Physical Activity Pre-Intervention	33.46 hours/week Standard Deviation 27.11
Self-reported Physical Activity Post-Intervention	59.50 hours/week Standard Deviation 55.45

Adverse Events

Mindfulness-Based Cognitive Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mindfulness-Based Cognitive Therapy n=19 participants at risk 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. 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.
Psychiatric disorders Adverse Event	5.3% 1/19 • Number of events 1 • The data were collected over 7 months.

Additional Information

Dr. Christina Luberto

Massachusetts General Hospital/Harvard Medical School

Phone: 617-643-9453

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place