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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04799899
• Other study ID #: 2021P000544
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: November 2023

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: November 2023
• Est. primary completion date: October 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiovascular Diseases
• Depression
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mongan Institute: Health Policy Research Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment feasibility: percent of participants screened eligible	Feasibility outcomes for recruitment will include: >70% meet screening criteria	6 months
Primary	Recruitment feasibility: percent of participants enrolled	Feasibility outcomes for recruitment will include: >70% of eligible enroll	6 months
Primary	MBCT feasibility: percent of participants retained	MBCT intervention feasibility will include: >75% of participants retained at post-assessment survey	6 months
Primary	MBCT feasibility: percent of participants adherent to treatment	MBCT intervention feasibility will include: >75% of participants attending 6/8 sessions	6 months
Primary	MBCT feasibility: percent of participants adherent to home practice	MBCT feasibility will include: >75% complete home practice at least 3 days/week	6 months
Primary	Control group feasibility: percent of participants retained	Control group feasibility will include: >75% of participants retained at post-assessment survey	6 months
Primary	Control group feasibility: percent of participants adherent to treatment	Control group feasibility will include: >75% of participants attending 6/8 sessions sessions	6 months
Primary	Control group feasibility: percent of participants adherent to home practice	Control group feasibility will include: >75% complete home practice at least 3 days/week	6 months
Primary	Videoconferencing feasibility: number of videoconferencing difficulties	Videoconferencing feasibility will be assessed by: <20% of sessions missed due to technical problems	6 months
Primary	Blood spot feasibility: percent of blood spot samples submitted at baseline	Blood spot feasibility will be assessed by >75% of samples submitted at baseline	6 months
Primary	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	6 months
Primary	Blood spot feasibility: percent of samples with quality adequate for analysis	Blood spot feasibility will be assessed by 80% of submitted samples having adequate quality for analysis	6 months
Primary	MBCT acceptability: ratings of intervention satisfaction	MBCT acceptability will be assessed by overall program satisfaction (1=not at all, 10=very much; M>7.5)	6 months
Primary	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
Primary	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
Primary	Control group acceptability: ratings of intervention satisfaction	Control group acceptability will be assessed by overall program satisfaction (1=not at all, 10=very much; M>7.5)	6 months
Primary	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
Primary	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
Primary	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
Primary	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; M>7.5)	6 months
Primary	Blood spot acceptability: blood spot collection comfort	Blood spot acceptability will be assessed by ratings of ease of level of pain (1=none, 10=extreme; M<2.0)	6 months