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

Depression Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiovascular Diseases
• Depression
• Syndrome

• NCT number: NCT04799899
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 22, 2021
• Completion date: November 2023