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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual MBCT Intervention | Experimental | 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). |
|
| Virtual Health Enhancement Control | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted MBCT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Feasibility: Percent of Participants Screened Eligible | Feasibility outcomes for recruitment will include: >70% meet screening criteria | 6 months |
| Recruitment Feasibility: Percent of Participants Enrolled | Feasibility outcomes for recruitment will include: >70% of eligible enroll | 6 months |
| MBCT Feasibility: Percent of Participants Retained | MBCT intervention feasibility will include: >75% of participants retained at post-assessment survey | 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. | 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. | 6 months |
| Control Group Feasibility: Percent of Participants Retained | Control group feasibility will include: >75% of participants retained at post-assessment survey | 6 months |
| Control Group Feasibility: Percent of Participants Adherent to Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Luberto, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mongan Institute: Health Policy Research Center | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34910821 | Derived | Tully PJ, Ang SY, Lee EJ, Bendig E, Bauereiss N, Bengel J, Baumeister H. Psychological and pharmacological interventions for depression in patients with coronary artery disease. Cochrane Database Syst Rev. 2021 Dec 15;12(12):CD008012. doi: 10.1002/14651858.CD008012.pub4. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Number of participants who completed the baseline survey and were randomized into a study arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Mindfulness Based Cognitive Therapy (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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment Feasibility: Percent of Participants Screened Eligible | Feasibility outcomes for recruitment will include: >70% meet screening criteria | The number of participants who were screened. | Posted | Count of Participants | Participants | 6 months |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christina Luberto | Massachusetts General Hopsital | 617-643-9453 | CLUBERTO@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2021 | Oct 18, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D054058 | Acute Coronary Syndrome |
| D003863 | Depression |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D001526 | Behavioral Symptoms |
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|
| Cardiac Health Enhancement | Behavioral | 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 will include: >75% of participants attending 6/8 sessions sessions. "Adherent to treatment" is defined as participants attending 6 out of 8 sessions. |
| 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. | 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 | 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. | 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 | 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 | 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 | 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 | 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. | 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 | 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 | 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) | 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. | 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. | 6 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire-9 (PHQ-9) was used to assess depression. There are 9 items in this scale and the minimum score is 0 and maximum score is 27. Higher scores indicate higher severity of depression. | Mean | Standard Deviation | score on scale |
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| Time Since Acute Coronary Syndrome (ACS) | Mean | Standard Deviation | Years |
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| Type of Acute Coronary Syndrome (ACS) | Count of Participants | Participants |
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| Primary | Recruitment Feasibility: Percent of Participants Enrolled | Feasibility outcomes for recruitment will include: >70% of eligible enroll | Participants who were deemed eligible in the study screening process. | Posted | Count of Participants | Participants | 6 months |
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| Primary | MBCT Feasibility: Percent of Participants Retained | MBCT intervention feasibility will include: >75% of participants retained at post-assessment survey | MBCT feasibility outcome only; Control Group was not analyzed for this outcome measure. | Posted | Count of Participants | Participants | 6 months |
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| Primary | 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. | MBCT outcome measure only; control group was not analyzed for this outcome measure. | Posted | Count of Participants | Participants | 6 months |
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| Primary | 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. | Participants (n = 10) in the MBCT intervention who completed the post intervention survey. Control group was not analyzed for this outcome measure. | Posted | Count of Participants | Participants | 6 months |
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| Primary | Control Group Feasibility: Percent of Participants Retained | Control group feasibility will include: >75% of participants retained at post-assessment survey | MBCT intervention group was not analyzed for this outcome measure. | Posted | Count of Participants | Participants | 6 months |
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| Primary | 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. | MBCT Intervention Group was not analyzed for this outcome measure. | Posted | Count of Participants | Participants | 6 months |
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| Primary | 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. | N = 8 participants completed the post intervention survey. MCBT intervention group was not analyzed for this outcome measure | Posted | Count of Participants | Participants | 6 months |
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| Primary | Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems | Videoconferencing feasibility will be assessed by: <20% of sessions missed due to technical problems | All participants who were randomized into study groups. Across all groups/arm, there were 32 sessions in the study. | Posted | Count of Units | Videoconferencing sessions | 6 months | Videoconferencing sessions | Videoconferencing sessions |
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| Primary | 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. | All participants | Posted | Count of Participants | Participants | At Baseline (Month 0) |
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| Primary | 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 | All participants | Posted | Count of Participants | Participants | At Post Intervention (Month 3) |
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| Primary | 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 | Participants who answered intervention satisfaction question on post intervention survey. Control Group was not analyzed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | At post intervention (Month 3) |
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| Primary | 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 | Participants who answered the relevant survey question on the post intervention survey. | Posted | Count of Participants | Participants | 6 months |
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| Primary | 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 | Number of participants who answered the relevant survey question on the post intervention survey. | Posted | Count of Participants | Participants | 6 months |
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| Primary | 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. | Number of participants who answered the relevant survey question on the post-intervention survey. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Primary | 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 | Number of participants who answered the relevant survey question on the post-intervention survey. | Posted | Count of Participants | Participants | 6 months |
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| Primary | 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 | Number of participants who answered the relevant survey question on the post-intervention survey. | Posted | Count of Participants | Participants | 6 months |
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| Primary | Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction | Videoconferencing acceptability will be assessed in terms of overall satisfaction (1=poor,10=excellent; M>7.5) | Participants who answered intervention satisfaction questions on post intervention survey. | Posted | Mean | Standard Deviation | Units on a scale | 6 months |
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| Primary | 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. | Participants who answered videoconferencing satisfaction question on post intervention survey. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| Primary | 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. | Participants who answered videoconferencing satisfaction question on post intervention survey. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D001519 |
| Behavior |