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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mindfulness-Based Cognitive Therapy Delivered Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms: A Pilot RCT

Conditions
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Cardiovascular Diseases, Acute Coronary Syndrome, Depression

Intervention / Treatment
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* Behavioral: Adapted MBCT
* Behavioral: Cardiac Health Enhancement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lifetime ACS per medical record and/or patient confirmation Current elevated depression symptoms (PHQ-9 greater than or equal to 5) Age 35-85 years Access to high-speed internet Exclusion Criteria: Active suicidal ideation or past-year psychiatric hospitalization (per patient report and/or medical record review) Non-English-speaking Cognitive impairments preventing informed consent per medical record review and/or cognitive Screen less than or equal to 4 Patient deemed unable to complete the study protocol or has a condition that would likely interfere with the study

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual MBCT Intervention<br>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<br>* 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.<br>|
| Experimental: Virtual Health Enhancement Control<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| MBCT feasibility: percent of participants adherent to treatment | MBCT intervention feasibility will include: >75% of participants attending 6/8 sessions | 6 months | 
| MBCT feasibility: percent of participants adherent to home practice | MBCT feasibility will include: >75% complete home practice at least 3 days/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 | Control group feasibility will include: >75% of participants attending 6/8 sessions 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 | 6 months | 
| Videoconferencing feasibility: number of videoconferencing difficulties | 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 | 6 months | 
| 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 | 6 months | 
| Blood spot feasibility: percent of samples with quality adequate for analysis | Blood spot feasibility will be assessed by 80% of submitted samples having adequate quality for analysis | 6 months | 
| MBCT acceptability: ratings of intervention satisfaction | MBCT acceptability will be assessed by overall program satisfaction (1=not at all, 10=very much; M>7.5) | 6 months | 
| 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 | 
| 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; M>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; M>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=none, 10=extreme; M<2.0) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Acute Coronary Syndrome, Videoconferencing, Depression