Trial Outcomes & Findings for MBCT Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms: A Pilot RCT (NCT NCT04799899)

NCT ID: NCT04799899

Last Updated: 2025-01-29

Results Overview

Feasibility outcomes for recruitment will include: \>70% meet screening criteria

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-01-29

Participant Flow

Of 407 participants recruited, 219 were screened. 63 were found ineligible and 108 declined to participate leaving 48 eligible participants. 18 refused to participate so 30 participants were consented to the study. 6 of those 30 consented participants did not complete the baseline survey or withdrew from the study, leaving 24 participants to be randomized into the intervention groups.

Participant milestones

Measure	Virtual MBCT Intervention Participants will participate in 8 weekly virtual group sessions of MBCT. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Adapted MBCT: The adapted MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will be taught how to use evidence-based mindfulness skills to regulate distress and choose healthy behaviors, as well as learn about cardiac health.	Virtual Health Enhancement Control Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Overall Study STARTED	12	12
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Measure	Virtual MBCT Intervention Participants will participate in 8 weekly virtual group sessions of MBCT. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Adapted MBCT: The adapted MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will be taught how to use evidence-based mindfulness skills to regulate distress and choose healthy behaviors, as well as learn about cardiac health.	Virtual Health Enhancement Control Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Overall Study Lost to Follow-up	2	4

Baseline Characteristics

MBCT Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms: A Pilot RCT

Baseline characteristics by cohort

Measure	Virtual Mindfulness Based Cognitive Therapy (MBCT) Intervention n=12 Participants Participants will participate in 8 weekly virtual group sessions of MBCT. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Adapted MBCT: The adapted MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will be taught how to use evidence-based mindfulness skills to regulate distress and choose healthy behaviors, as well as learn about cardiac health.	Virtual Health Enhancement Control n=12 Participants Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.	Total n=24 Participants Total of all reporting groups
Age, Continuous	57.92 years STANDARD_DEVIATION 10.950 • n=5 Participants	57.42 years STANDARD_DEVIATION 12.266 • n=7 Participants	57.67 years STANDARD_DEVIATION 11.374 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Patient Health Questionnaire (PHQ-9)	9.67 score on scale STANDARD_DEVIATION 4.097 • n=5 Participants	12.42 score on scale STANDARD_DEVIATION 6.543 • n=7 Participants	11.04 score on scale STANDARD_DEVIATION 5.521 • n=5 Participants
Time Since Acute Coronary Syndrome (ACS)	3.38 Years STANDARD_DEVIATION 3.844 • n=5 Participants	2.39 Years STANDARD_DEVIATION 1.77 • n=7 Participants	2.88 Years STANDARD_DEVIATION 2.97 • n=5 Participants
Type of Acute Coronary Syndrome (ACS) Myocardial infarction (MI)	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Type of Acute Coronary Syndrome (ACS) Non-ST-elevation myocardial infarction (NSTEMI)	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Type of Acute Coronary Syndrome (ACS) Spontaneous coronary artery dissection (SCAD)	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Type of Acute Coronary Syndrome (ACS) Unstable Angina (UA)	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Type of Acute Coronary Syndrome (ACS) ST-elevation myocardial infarction (STEMI)	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Type of Acute Coronary Syndrome (ACS) SCAD & NSTEMI	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Type of Acute Coronary Syndrome (ACS) NSTEMI & STEMI	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Type of Acute Coronary Syndrome (ACS) SCAD & STEMI	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Type of Acute Coronary Syndrome (ACS) MI & STEMI	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Type of Acute Coronary Syndrome (ACS) NSTEMI & UA & SCAD	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Type of Acute Coronary Syndrome (ACS) STEMI & UA	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The number of participants who were screened.

Feasibility outcomes for recruitment will include: >70% meet screening criteria

Outcome measures

Measure	Screened Participants n=219 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Recruitment Feasibility: Percent of Participants Screened Eligible	48 Participants	—

PRIMARY outcome

Timeframe: 6 months

Population: Participants who were deemed eligible in the study screening process.

Feasibility outcomes for recruitment will include: >70% of eligible enroll

Outcome measures

Measure	Screened Participants n=48 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Recruitment Feasibility: Percent of Participants Enrolled	24 Participants	—

PRIMARY outcome

Timeframe: 6 months

Population: MBCT feasibility outcome only; Control Group was not analyzed for this outcome measure.

MBCT intervention feasibility will include: >75% of participants retained at post-assessment survey

Outcome measures

Measure	Screened Participants n=12 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
MBCT Feasibility: Percent of Participants Retained	10 Participants	—

PRIMARY outcome

Timeframe: 6 months

Population: MBCT outcome measure only; control group was not analyzed for this outcome measure.

MBCT intervention feasibility will include: >75% of participants attending 6/8 sessions. "Adherent to treatment" is defined as participants attending 6 out of 8 sessions.

Outcome measures

Measure	Screened Participants n=12 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Treatment	6 Participants	—

PRIMARY outcome

Timeframe: 6 months

Population: Participants (n = 10) in the MBCT intervention who completed the post intervention survey. Control group was not analyzed for this outcome measure.

MBCT feasibility will include: >75% complete home practice at least 3 days/week. Adherence was defined as completion of home practice long at least 3 days per week.

Outcome measures

Measure	Screened Participants n=10 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Home Practice	8 Participants	—

PRIMARY outcome

Timeframe: 6 months

Population: MBCT intervention group was not analyzed for this outcome measure.

Control group feasibility will include: >75% of participants retained at post-assessment survey

Outcome measures

Measure	Screened Participants n=12 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Control Group Feasibility: Percent of Participants Retained	8 Participants	—

PRIMARY outcome

Timeframe: 6 months

Population: MBCT Intervention Group was not analyzed for this outcome measure.

Control group feasibility will include: >75% of participants attending 6/8 sessions sessions. "Adherent to treatment" is defined as participants attending 6 out of 8 sessions.

Outcome measures

Measure	Screened Participants n=12 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Control Group Feasibility: Percent of Participants Adherent to Treatment	8 Participants	—

PRIMARY outcome

Timeframe: 6 months

Population: N = 8 participants completed the post intervention survey. MCBT intervention group was not analyzed for this outcome measure

Control group feasibility will include: >75% complete home practice at least 3 days/week. "Adherent to home practice" is defined as participants completing home practice at least 3 days per week.

Outcome measures

Measure	Screened Participants n=8 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Control Group Feasibility: Percent of Participants Adherent to Home Practice	4 Participants	—

PRIMARY outcome

Timeframe: 6 months

Population: All participants who were randomized into study groups. Across all groups/arm, there were 32 sessions in the study.

Videoconferencing feasibility will be assessed by: <20% of sessions missed due to technical problems

Outcome measures

Measure	Screened Participants n=16 Videoconferencing sessions This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control n=16 Videoconferencing sessions Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems	0 Videoconferencing sessions	0 Videoconferencing sessions

PRIMARY outcome

Timeframe: At Baseline (Month 0)

Population: All participants

Blood spot feasibility will be assessed by >75% of samples submitted at baseline. Participants contributed one blood spot sample at the specified time point.

Outcome measures

Measure	Screened Participants n=12 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control n=12 Participants Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Baseline	11 Participants	11 Participants

PRIMARY outcome

Timeframe: At Post Intervention (Month 3)

Population: All participants

Blood spot feasibility will be assessed by >75% of samples submitted at post-intervention

Outcome measures

Measure	Screened Participants n=12 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control n=12 Participants Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Post-intervention	8 Participants	7 Participants

PRIMARY outcome

Timeframe: At post intervention (Month 3)

Population: Participants who answered intervention satisfaction question on post intervention survey. Control Group was not analyzed for this outcome measure.

MBCT acceptability will be assessed by overall program satisfaction (1=not at all, 10=very much). Satisfaction will be measured by mean score greater than 7.5

Outcome measures

Measure	Screened Participants n=9 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Ratings of Intervention Satisfaction	8.67 score on a scale Standard Deviation 2.598	—

PRIMARY outcome

Timeframe: 6 months

Population: Participants who answered the relevant survey question on the post intervention survey.

MBCT and acceptability will be assessed by 75% plan to use the skills

Outcome measures

Measure	Screened Participants n=8 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Plan to Continue Using the Skills	8 Participants	—

PRIMARY outcome

Timeframe: 6 months

Population: Number of participants who answered the relevant survey question on the post intervention survey.

MBCT and acceptability will be assessed by >75% of participants reporting that they would recommend the program to others

Outcome measures

Measure	Screened Participants n=8 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Would Recommend the Program	8 Participants	—

PRIMARY outcome

Timeframe: 6 months

Population: Number of participants who answered the relevant survey question on the post-intervention survey.

Control group acceptability will be assessed by overall program satisfaction (1=not at all, 10=very much). Satisfaction will be measured by an overall mean score greater than 7.5.

Outcome measures

Measure	Screened Participants n=8 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Control Group Acceptability: Ratings of Intervention Satisfaction	8.13 score on a scale Standard Deviation 1.959	—

PRIMARY outcome

Timeframe: 6 months

Population: Number of participants who answered the relevant survey question on the post-intervention survey.

Control group acceptability will be assessed by 75% of participants reporting that they plan to use the skills

Outcome measures

Measure	Screened Participants n=8 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Control Group Acceptability: Percent of Participants Who Plan to Continue Using the Skills	8 Participants	—

PRIMARY outcome

Timeframe: 6 months

Population: Number of participants who answered the relevant survey question on the post-intervention survey.

Control group acceptability will be assessed by >75% of participants reporting that they would recommend the program to others

Outcome measures

Measure	Screened Participants n=8 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Control Group Acceptability: Percent of Participants Who Would Recommend the Program	8 Participants	—

PRIMARY outcome

Timeframe: 6 months

Population: Participants who answered intervention satisfaction questions on post intervention survey.

Videoconferencing acceptability will be assessed in terms of overall satisfaction (1=poor,10=excellent; M>7.5)

Outcome measures

Measure	Screened Participants n=8 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control n=8 Participants Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction	9.75 Units on a scale Standard Deviation .463	9.63 Units on a scale Standard Deviation 1.061

PRIMARY outcome

Timeframe: 6 months

Population: Participants who answered videoconferencing satisfaction question on post intervention survey.

Blood spot acceptability will be assessed by ratings of ease of data collection (1=not at all, 10=extremely). Satisfaction will be measured by an overall mean score greater than 7.5.

Outcome measures

Measure	Screened Participants n=10 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control n=8 Participants Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Blood Spot Acceptability: Blood Spot Collection Ease	8.50 units on a scale Standard Deviation 2.121	8.38 units on a scale Standard Deviation 3.159

PRIMARY outcome

Timeframe: 6 months

Population: Participants who answered videoconferencing satisfaction question on post intervention survey.

Blood spot acceptability will be assessed by ratings of ease of level of pain (1=very much pain, 10=very little pain; M>8.0). Acceptability will be measured by an overall mean score greater than 8.0.

Outcome measures

Measure	Screened Participants n=10 Participants This group contains all participants who were screened as part of the study enrollment process.	Virtual Health Enhancement Control n=8 Participants Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Blood Spot Acceptability: Blood Spot Collection Comfort	9.10 units on a scale Standard Deviation 1.595	9.50 units on a scale Standard Deviation 1.069

Adverse Events

Virtual MBCT Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Virtual Health Enhancement Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christina Luberto

Massachusetts General Hopsital

Phone: 617-643-9453

Email: CLUBERTO@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place