MBCT Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms: A Pilot RCT
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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). |
Behavioral: 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.
|
| Experimental: 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). |
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- Recruitment feasibility: percent of participants recruited and enrolled [6 months]
Feasibility outcomes for recruitment will include: >70% consent to screening; >70% meet screening criteria; >70% of eligible enroll; enroll >20 participants/month
- Eligibility feasibility: percent of participants determined eligible [6 months]
Eligibility feasibility will include: < 20% ineligible due to each criterion; reasons for ineligibility; reasons for refusal; characteristics of refusers
- MBCT intervention and control group feasibility: percent of participants adherent to their assigned treatment group [6 months]
MBCT intervention and control group feasibility will include: Adherence: >75% session attendance; retention: >75% post-assessments, >70% follow-up assessments completed; fidelity: checklist score >80%; >75% complete home practice at least 3 days/week
- Videoconferencing feasibility: number and type of videoconferencing difficulties [6 months]
Videoconferencing feasibility will be assessed by: <20% of connections dropped during session; <20% of sessions missed due to technical problems; number (M<2.0) and type of problems; <20% ask for extra training, type of extra training needed
- Blood spot feasibility: rate of adequate blood spot sample completion [6 months]
Blood spot feasibility will be assessed by >75% of samples submitted at baseline, post-intervention, >60% submitted at follow-up; 80% adequate quality
- MBCT and control group acceptability: ratings of intervention satisfaction [6 months]
MBCT and control group acceptability will be assessed by session satisfaction and helpfulness, enjoyment, relevance, utility of each session component (1=not at all, 10=very much; M>7.5; post-session survey); overall program satisfaction (M>7.5), >75% plan to use the skills, >75% would recommend the program to others (post-intervention survey); likes, dislikes, suggestions for improvement (exit interview); >60% continue meditation practice (follow-up survey)
- Videoconferencing acceptability: ratings of videoconferencing satisfaction [6 months]
Videoconferencing acceptability will be assessed in terms of ease and confidence of use (1=not at all, 10=extremely M>7.5), interference of technical problems (1=none, 10=extreme; M<2.0), audiovisual quality and overall satisfaction (1=poor,10=excellent; M>7.5; post-session survey); pros and cons, suggestions for improvement (exit interview)
- Blood spot acceptability: blood spot collection ease and comfort [6 months]
Blood spot acceptability will be assessed by ratings of ease of data collection and submission (1=not at all, 10=extremely; M>7.5), level of pain (1=none, 10=extreme; M<2.0; post-intervention survey); concerns, suggestions for improvement (exit interview)
Secondary Outcome Measures
- Patient Health Questionnaire-9 (PHQ-9) [6 months]
This is a 9-item scale that measures depression. The scoring scale ranges from 0, not at all, to 3, nearly every day. The scoring values range from 0 to27, where high values represent higher levels of depression and lower values represent lower levels of depression. Data collection for this measurement is longitudinal, and is performed during 30-90 minute time intervals one week before and after the intervention and at 3 months post-intervention.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Lifetime ACS per medical record and/or patient confirmation
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Current elevated depression symptoms (PHQ-9 greater than or equal to 5)
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Age 35-85 years
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Access to high-speed internet
Exclusion Criteria:
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Active suicidal ideation or past-year psychiatric hospitalization (per patient report and/or medical record review)
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Non-English-speaking
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Cognitive impairments preventing informed consent per medical record review and/or cognitive Screen less than or equal to 4
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Patient deemed unable to complete the study protocol or has a condition that would likely interfere with the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mongan Institute: Health Policy Research Center | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: Christina Luberto, PhD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021P000544