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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
Mongan Institute: Health Policy Research Center
Boston, Massachusetts, United States
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
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