Clinical trial NCT04799899: MBCT Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms: A Pilot RCT
Official title: Mindfulness-Based Cognitive Therapy Delivered Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms: A Pilot RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Acute Coronary Syndrome
Depression
Keywords: Mindfulness
Acute Coronary Syndrome
Videoconferencing
Depression
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Lifetime ACS per medical record and/or patient confirmation
2. Current elevated depression symptoms (PHQ-9 greater than or equal to 5)
3. Age 35-85 years
4. Access to high-speed internet

Exclusion Criteria:

1. Active suicidal ideation or past-year psychiatric hospitalization (per patient report and/or medical record review)
2. Non-English-speaking
3. Cognitive impairments preventing informed consent per medical record review and/or cognitive Screen less than or equal to 4
4. Patient deemed unable to complete the study protocol or has a condition that would likely interfere with the study

Primary outcomes:
measure: Recruitment Feasibility: Percent of Participants Screened Eligible
timeFrame: 6 months
measure: Recruitment Feasibility: Percent of Participants Enrolled
timeFrame: 6 months
measure: MBCT Feasibility: Percent of Participants Retained
timeFrame: 6 months
measure: Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Treatment
timeFrame: 6 months
measure: Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Home Practice
timeFrame: 6 months
measure: Control Group Feasibility: Percent of Participants Retained
timeFrame: 6 months
measure: Control Group Feasibility: Percent of Participants Adherent to Treatment
timeFrame: 6 months
measure: Control Group Feasibility: Percent of Participants Adherent to Home Practice
timeFrame: 6 months
measure: Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems
timeFrame: 6 months
measure: Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Baseline
timeFrame: At Baseline (Month 0)
measure: Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Post-intervention
timeFrame: At Post Intervention (Month 3)
measure: Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Ratings of Intervention Satisfaction
timeFrame: At post intervention (Month 3)
measure: Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Plan to Continue Using the Skills
timeFrame: 6 months
measure: Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Would Recommend the Program
timeFrame: 6 months
measure: Control Group Acceptability: Ratings of Intervention Satisfaction
timeFrame: 6 months
measure: Control Group Acceptability: Percent of Participants Who Plan to Continue Using the Skills
timeFrame: 6 months
measure: Control Group Acceptability: Percent of Participants Who Would Recommend the Program
timeFrame: 6 months
measure: Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction
timeFrame: 6 months
measure: Blood Spot Acceptability: Blood Spot Collection Ease
timeFrame: 6 months
measure: Blood Spot Acceptability: Blood Spot Collection Comfort
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mongan Institute: Health Policy Research Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Christina Luberto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tully PJ, Ang SY, Lee EJ, Bendig E, Bauereiss N, Bengel J, Baumeister H. Psychological and pharmacological interventions for depression in patients with coronary artery disease. Cochrane Database Syst Rev. 2021 Dec 15;12(12):CD008012. doi: 10.1002/14651858.CD008012.pub4.