Skip to main content
OpenTrials
Completed

NCT Number: NCT04799899

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Diseases Acute Coronary Syndrome Behavior Behavioral Symptoms Depression Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mongan Institute: Health Policy Research Center

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Recruitment Feasibility: Percent of Participants Screened Eligible

    Time frame: 6 months

    Feasibility outcomes for recruitment will include: >70% meet screening criteria

  2. Recruitment Feasibility: Percent of Participants Enrolled

    Time frame: 6 months

    Feasibility outcomes for recruitment will include: >70% of eligible enroll

  3. MBCT Feasibility: Percent of Participants Retained

    Time frame: 6 months

    MBCT intervention feasibility will include: >75% of participants retained at post-assessment survey

  4. Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Treatment

    Time frame: 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.

  5. Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Home Practice

    Time frame: 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.

  6. Control Group Feasibility: Percent of Participants Retained

    Time frame: 6 months

    Control group feasibility will include: >75% of participants retained at post-assessment survey

  7. Control Group Feasibility: Percent of Participants Adherent to Treatment

    Time frame: 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.

  8. Control Group Feasibility: Percent of Participants Adherent to Home Practice

    Time frame: 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.

  9. Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems

    Time frame: 6 months

    Videoconferencing feasibility will be assessed by: <20% of sessions missed due to technical problems

  10. Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Baseline

    Time frame: 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.

  11. Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Post-intervention

    Time frame: At Post Intervention (Month 3)

    Blood spot feasibility will be assessed by >75% of samples submitted at post-intervention

  12. Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Ratings of Intervention Satisfaction

    Time frame: 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

  13. Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Plan to Continue Using the Skills

    Time frame: 6 months

    MBCT and acceptability will be assessed by 75% plan to use the skills

  14. Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Would Recommend the Program

    Time frame: 6 months

    MBCT and acceptability will be assessed by >75% of participants reporting that they would recommend the program to others

  15. Control Group Acceptability: Ratings of Intervention Satisfaction

    Time frame: 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.

  16. Control Group Acceptability: Percent of Participants Who Plan to Continue Using the Skills

    Time frame: 6 months

    Control group acceptability will be assessed by 75% of participants reporting that they plan to use the skills

  17. Control Group Acceptability: Percent of Participants Who Would Recommend the Program

    Time frame: 6 months

    Control group acceptability will be assessed by >75% of participants reporting that they would recommend the program to others

  18. Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction

    Time frame: 6 months

    Videoconferencing acceptability will be assessed in terms of overall satisfaction (1=poor,10=excellent; M>7.5)

  19. Blood Spot Acceptability: Blood Spot Collection Ease

    Time frame: 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.

  20. Blood Spot Acceptability: Blood Spot Collection Comfort

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 16, 2021
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.