An interventional study of Adapted MBCT and Cardiac Health Enhancement in Cardiovascular Diseases, Acute Coronary Syndrome and Depression, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
The aim of this study is to establish, in a pilot RCT (approx. N=50 participants) with a time- and attention-matched health enhancement control, (a) the feasibility of the recruitment procedures (screening, eligibility, enrollment rates), and feasibility and acceptability of the (b) MBCT and control interventions (adherence, retention, fidelity, satisfaction, group videoconferencing delivery) and (c) data collection procedures by group (adherence, satisfaction). Hypothesis 1a: Recruitment will be feasible as evidenced by screening, eligibility, and enrollment rates; (1b) the MBCT and control interventions and (1c) data collection procedures in both groups will be feasible and acceptable.
The current study will employ an open pilot RCT with a time-and-attention-matched health control group to determine the feasibility and acceptability of a virtual, MBCT intervention for ACS patients. The investigators plan to enroll approximately N=50 participants (approx. 3 MBCT groups and approx. 3 health enhancement control groups with approximately 6-7 participants per group; accounting for 20% attrition). Participants will be randomized to a MBCT or a time- and attention-matched health enhancement control in a 1:1 design using a random number generator. Participants will then be stratified by antidepressant medication use. The 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. The health enhancement control group will follow the same structure of the MBCT intervention (e.g., 8 virtually-delivered MBCT sessions, approximately 1.5 hours each) and will educate participants on depression and cardiac health (e.g., relationship between depression and cardiac health, cardiac risk factors, cardiac health behaviors, finding resources for mental health care). 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).
Participants will be recruited through EPIC, the hospital's clinical data registry, advertisements (e.g., flyers, brochures) placed throughout the hospital, direct provider referrals, and from inpatient cardiac units. Patients who express interest in the study will be asked complete an eligibility screening. Eligible patients agreeable with study participation will then complete informed consent with study staff prior to enrollment.
Participants will be enrolled in either one of three MBCT intervention cohorts (approx.) or one of three health enhancement control cohorts (approx.). Participants in all of these groups will be expected to participate in 8-weekly, 1.5-hour virtual sessions. Participants in the MBCT intervention group will be expected to participate in 30 minutes of at-home daily practice. Participants in the health enhancement control group will be expected to review educational videos or readings between sessions. A licensed mental health provider (e.g., LICSW, PhD) trained in the MBCT protocol will delivered the intervention to the MBCT intervention group. A licensed clinician or pre-doctoral or post-doctoral fellow with supervision from a licensed clinician will lead the control group. Both the MBCT intervention and health enhancement control groups will be delivered via Zoom, secure, HIPPA-compliant video-conferencing software.
Study assessments will include a battery of self-report surveys administered at baseline, post-intervention, and 3-month follow-up; session satisfaction surveys administered after each intervention session; post-intervention individual exit interviews (conducted via telephone or videoconference); blood spot samples self-collected by participants at baseline, post-intervention, and 3-month follow-up (submitted to the research team via paper mail); and, for the MBCT-intervention group, home practice logs submitted between each intervention session. Primary outcomes for the intervention are feasibility and acceptability. Exploratory outcomes are changes in emotional and biological variables. Data collected from this study will generate knowledge about e-health technologies and congruent research methods to apply to other mind-body interventions and patient populations.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 24 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Behavioral: Adapted MBCT
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).
Behavioral: Cardiac Health Enhancement
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.
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
Feasibility outcomes for recruitment will include: \>70% meet screening criteria
Time frame: 6 months
Recruitment Feasibility: Percent of Participants Enrolled
Feasibility outcomes for recruitment will include: \>70% of eligible enroll
Time frame: 6 months
MBCT Feasibility: Percent of Participants Retained
MBCT intervention feasibility will include: \>75% of participants retained at post-assessment survey
Time frame: 6 months
Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Treatment
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.
Time frame: 6 months
Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Home Practice
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.
Time frame: 6 months
Control Group Feasibility: Percent of Participants Retained
Control group feasibility will include: \>75% of participants retained at post-assessment survey
Time frame: 6 months
Control Group Feasibility: Percent of Participants Adherent to Treatment
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.
Time frame: 6 months
Control Group Feasibility: Percent of Participants Adherent to Home Practice
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.
Time frame: 6 months
Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems
Videoconferencing feasibility will be assessed by: \<20% of sessions missed due to technical problems
Time frame: 6 months
Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Baseline
Blood spot feasibility will be assessed by \>75% of samples submitted at baseline. Participants contributed one blood spot sample at the specified time point.
Time frame: At Baseline (Month 0)
Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Post-intervention
Blood spot feasibility will be assessed by \>75% of samples submitted at post-intervention
Time frame: At Post Intervention (Month 3)
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Ratings of Intervention Satisfaction
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
Time frame: At post intervention (Month 3)
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Plan to Continue Using the Skills
MBCT and acceptability will be assessed by 75% plan to use the skills
Time frame: 6 months
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Would Recommend the Program
MBCT and acceptability will be assessed by \>75% of participants reporting that they would recommend the program to others
Time frame: 6 months
Control Group Acceptability: Ratings of Intervention Satisfaction
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.
Time frame: 6 months
Control Group Acceptability: Percent of Participants Who Plan to Continue Using the Skills
Control group acceptability will be assessed by 75% of participants reporting that they plan to use the skills
Time frame: 6 months
Control Group Acceptability: Percent of Participants Who Would Recommend the Program
Control group acceptability will be assessed by \>75% of participants reporting that they would recommend the program to others
Time frame: 6 months
Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction
Videoconferencing acceptability will be assessed in terms of overall satisfaction (1=poor,10=excellent; M\>7.5)
Time frame: 6 months
Blood Spot Acceptability: Blood Spot Collection Ease
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.
Time frame: 6 months
Blood Spot Acceptability: Blood Spot Collection Comfort
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.
Time frame: 6 months
| Milestone | Virtual MBCT Intervention | Virtual Health Enhancement Control |
|---|---|---|
| Started | 12 | 12 |
| Completed | 10 | 8 |
| Not completed | 2 | 4 |
| Withdrew: Lost to follow-up | 2 | 4 |
Feasibility outcomes for recruitment will include: \>70% meet screening criteria
| Participants | Screened Participants |
|---|---|
| Recruitment Feasibility: Percent of Participants Screened Eligible | 48 |
Feasibility outcomes for recruitment will include: \>70% of eligible enroll
| Participants | Eligible Participants |
|---|---|
| Recruitment Feasibility: Percent of Participants Enrolled | 24 |
MBCT intervention feasibility will include: \>75% of participants retained at post-assessment survey
| Participants | Virtual MBCT Intervention |
|---|---|
| MBCT Feasibility: Percent of Participants Retained | 10 |
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.
| Participants | Virtual MBCT Intervention |
|---|---|
| Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Treatment | 6 |
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.
| Participants | Virtual MBCT Intervention |
|---|---|
| Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Home Practice | 8 |
Control group feasibility will include: \>75% of participants retained at post-assessment survey
| Participants | Virtual Health Enhancement Control |
|---|---|
| Control Group Feasibility: Percent of Participants Retained | 8 |
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.
| Participants | Virtual Health Enhancement Control |
|---|---|
| Control Group Feasibility: Percent of Participants Adherent to Treatment | 8 |
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.
| Participants | Virtual Health Enhancement Control |
|---|---|
| Control Group Feasibility: Percent of Participants Adherent to Home Practice | 4 |
Videoconferencing feasibility will be assessed by: \<20% of sessions missed due to technical problems
| Videoconferencing sessions | Virtual MBCT Intervention | Virtual Health Enhancement Control |
|---|---|---|
| Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems | 0 | 0 |
Blood spot feasibility will be assessed by \>75% of samples submitted at baseline. Participants contributed one blood spot sample at the specified time point.
| Participants | Virtual MBCT Intervention | Virtual Health Enhancement Control |
|---|---|---|
| Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Baseline | 11 | 11 |
Blood spot feasibility will be assessed by \>75% of samples submitted at post-intervention
| Participants | Virtual MBCT Intervention | Virtual Health Enhancement Group |
|---|---|---|
| Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Post-intervention | 8 | 7 |
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
| score on a scale | Virtual MBCT Intervention |
|---|---|
| Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Ratings of Intervention Satisfaction | 8.67 ± 2.598 |
MBCT and acceptability will be assessed by 75% plan to use the skills
| Participants | Virtual MBCT Intervention |
|---|---|
| Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Plan to Continue Using the Skills | 8 |
MBCT and acceptability will be assessed by \>75% of participants reporting that they would recommend the program to others
| Participants | Virtual MBCT Intervention |
|---|---|
| Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Would Recommend the Program | 8 |
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.
| score on a scale | Virtual Health Enhancement Control |
|---|---|
| Control Group Acceptability: Ratings of Intervention Satisfaction | 8.13 ± 1.959 |
Control group acceptability will be assessed by 75% of participants reporting that they plan to use the skills
| Participants | Virtual Health Enhancement Control |
|---|---|
| Control Group Acceptability: Percent of Participants Who Plan to Continue Using the Skills | 8 |
Control group acceptability will be assessed by \>75% of participants reporting that they would recommend the program to others
| Participants | Virtual Health Enhancement Control |
|---|---|
| Control Group Acceptability: Percent of Participants Who Would Recommend the Program | 8 |
Videoconferencing acceptability will be assessed in terms of overall satisfaction (1=poor,10=excellent; M\>7.5)
| Units on a scale | Virtual MBCT Intervention | Virtual Health Enhancement Control |
|---|---|---|
| Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction | 9.75 ± .463 | 9.63 ± 1.061 |
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.
| units on a scale | Virtual MBCT Intervention | Virtual Health Enhancement Control |
|---|---|---|
| Blood Spot Acceptability: Blood Spot Collection Ease | 8.50 ± 2.121 | 8.38 ± 3.159 |
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.
| units on a scale | Virtual MBCT Intervention | Virtual Health Enhancement Control |
|---|---|---|
| Blood Spot Acceptability: Blood Spot Collection Comfort | 9.10 ± 1.595 | 9.50 ± 1.069 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Virtual MBCT Intervention | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Virtual Health Enhancement Control | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
Number of participants who completed the baseline survey and were randomized into a study arm.
| Age, Continuous(years) | Virtual Mindfulness Based Cognitive Therapy (MBCT) Intervention | Virtual Health Enhancement Control | Total |
|---|---|---|---|
| Mean | 57.92 ± 10.950 | 57.42 ± 12.266 | 57.67 ± 11.374 |
| Sex: Female, Male(Participants) | Virtual Mindfulness Based Cognitive Therapy (MBCT) Intervention | Virtual Health Enhancement Control | Total |
|---|---|---|---|
| Female | 5 | 10 | 15 |
| Male | 7 | 2 | 9 |
| Ethnicity (NIH/OMB)(Participants) | Virtual Mindfulness Based Cognitive Therapy (MBCT) Intervention | Virtual Health Enhancement Control | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 0 | 3 |
| Not Hispanic or Latino | 9 | 12 | 21 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Virtual Mindfulness Based Cognitive Therapy (MBCT) Intervention | Virtual Health Enhancement Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 9 | 12 | 21 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 0 | 3 |
| Patient Health Questionnaire (PHQ-9)(score on scale) | Virtual Mindfulness Based Cognitive Therapy (MBCT) Intervention | Virtual Health Enhancement Control | Total |
|---|---|---|---|
| Mean | 9.67 ± 4.097 | 12.42 ± 6.543 | 11.04 ± 5.521 |
| Time Since Acute Coronary Syndrome (ACS)(Years) | Virtual Mindfulness Based Cognitive Therapy (MBCT) Intervention | Virtual Health Enhancement Control | Total |
|---|---|---|---|
| Mean | 3.38 ± 3.844 | 2.39 ± 1.77 | 2.88 ± 2.97 |
| Type of Acute Coronary Syndrome (ACS)(Participants) | Virtual Mindfulness Based Cognitive Therapy (MBCT) Intervention | Virtual Health Enhancement Control | Total |
|---|---|---|---|
| Myocardial infarction (MI) | 1 | 0 | 1 |
| Non-ST-elevation myocardial infarction (NSTEMI) | 3 | 5 | 8 |
| Spontaneous coronary artery dissection (SCAD) | 3 | 3 | 6 |
| Unstable Angina (UA) | 1 | 0 | 1 |
| ST-elevation myocardial infarction (STEMI) | 2 | 0 | 2 |
| SCAD & NSTEMI | 0 | 1 | 1 |
| NSTEMI & STEMI | 1 | 0 | 1 |
| SCAD & STEMI | 0 | 1 | 1 |
| MI & STEMI | 0 | 1 | 1 |
| NSTEMI & UA & SCAD | 0 | 1 | 1 |
| STEMI & UA | 1 | 0 | 1 |
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