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

Not Applicable

Completed

Conditions: Cardiovascular Diseases
Acute Coronary Syndrome
Depression

Interventions: Behavioral: Adapted MBCT
Behavioral: Cardiac Health Enhancement

Registration Number: NCT04799899

Lead Sponsor: Massachusetts General Hospital

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual MBCT Intervention	Adapted MBCT	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	Cardiac Health Enhancement	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).

Primary Outcome Measures

Name	Time	Method
Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems	6 months	Videoconferencing feasibility will be assessed by: \<20% of sessions missed due to technical problems
Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Baseline	At Baseline (Month 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.
Recruitment Feasibility: Percent of Participants Screened Eligible	6 months	Feasibility outcomes for recruitment will include: \>70% meet screening criteria
MBCT Feasibility: Percent of Participants Retained	6 months	MBCT intervention feasibility will include: \>75% of participants retained at post-assessment survey
Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Treatment	6 months	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.
Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Home Practice	6 months	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.
Recruitment Feasibility: Percent of Participants Enrolled	6 months	Feasibility outcomes for recruitment will include: \>70% of eligible enroll
Control Group Feasibility: Percent of Participants Retained	6 months	Control group feasibility will include: \>75% of participants retained at post-assessment survey
Control Group Feasibility: Percent of Participants Adherent to Treatment	6 months	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.
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Ratings of Intervention Satisfaction	At post intervention (Month 3)	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
Control Group Feasibility: Percent of Participants Adherent to Home Practice	6 months	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.
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Would Recommend the Program	6 months	MBCT and acceptability will be assessed by \>75% of participants reporting that they would recommend the program to others
Control Group Acceptability: Ratings of Intervention Satisfaction	6 months	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.
Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Post-intervention	At Post Intervention (Month 3)	Blood spot feasibility will be assessed by \>75% of samples submitted at post-intervention
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Plan to Continue Using the Skills	6 months	MBCT and acceptability will be assessed by 75% plan to use the skills
Control Group Acceptability: Percent of Participants Who Plan to Continue Using the Skills	6 months	Control group acceptability will be assessed by 75% of participants reporting that they plan to use the skills
Control Group Acceptability: Percent of Participants Who Would Recommend the Program	6 months	Control group acceptability will be assessed by \>75% of participants reporting that they would recommend the program to others
Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction	6 months	Videoconferencing acceptability will be assessed in terms of overall satisfaction (1=poor,10=excellent; M\>7.5)
Blood Spot Acceptability: Blood Spot Collection Ease	6 months	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.
Blood Spot Acceptability: Blood Spot Collection Comfort	6 months	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.