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

NCT04799899 | Completed Results

• 1 other identifier: 2021P000544
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Acute Coronary Syndrome; Depression

Keywords

Mindfulness; Acute Coronary Syndrome; Videoconferencing; Depression

Outcome Measures

Primary Outcomes (20)

• Recruitment Feasibility: Percent of Participants Screened Eligible

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

  6 months

• Recruitment Feasibility: Percent of Participants Enrolled

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

  6 months

• MBCT Feasibility: Percent of Participants Retained

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

  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.

  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.

  6 months

• Control Group Feasibility: Percent of Participants Retained

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

  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.

  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.

  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

  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.

  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

  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

  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

  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

  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.

  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

  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

  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)

  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.

  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.

  6 months

Study Arms (2)

Virtual MBCT Intervention

EXPERIMENTAL

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

Virtual Health Enhancement Control

EXPERIMENTAL

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

Interventions

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.

Virtual MBCT Intervention

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.

Virtual Health Enhancement Control

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Mongan Institute: Health Policy Research Center

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 34910821 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Acute Coronary Syndrome; Depression

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Christina Luberto
• Organization: Massachusetts General Hopsital

CLUBERTO@mgh.harvard.edu

617-643-9453

Study Officials

• Christina Luberto, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry, Harvard Medical School; Staff Psychologist, Massachusetts General Hospital

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 16, 2021
• Study Start: April 22, 2021
• Primary Completion: October 5, 2022
• Study Completion: January 28, 2023
• Last Updated: January 29, 2025
• Results First Posted: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)