MBCT Delivered Via Group Videoconferencing for ACS Syndrome Patients With Depressive Symptoms

NCT04231097 | Completed Results

• 1 other identifier: 2020P000045
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary: The aim of this study is to explore the initial feasibility and acceptability of (a) Mindfulness-Based Cognitive Therapy (MBCT) adapted for ACS patients; (b) the group videoconferencing delivery medium; and (c) dried blood spot research procedures, to inform refinements for a subsequent pilot RCT.

Conditions

Acute Coronary Syndrome; Depression; Myocardial Infarction; Unstable Angina; STEMI; NSTEMI - Non-ST Segment Elevation MI

Keywords

Mindfulness; Acute Coronary Syndrome; Videoconferencing; Depression

Outcome Measures

Primary Outcomes (17)

• Recruitment Feasibility: Percent of Participants Who Consent to Screening

  Feasibility outcomes for recruitment will include: \>70% of patients reached consent to screening

  6 months

• Recruitment Feasibility: Percent of Participants Meeting Screening Criteria

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

  6 months

• Recruitment Feasibility: Percent of Eligible Patients Who Consent

  Feasibility outcomes for recruitment will include: \>70% of eligible consent to the study

  6 Months

• MBCT Feasibility: Percent of Participants Adherent to the MBCT Intervention

  MBCT feasibility will be measured by: \>75% session attendance (i.e., percent who attend at least 6/8 intervention sessions)

  6 Months

• MBCT Feasibility: Percent of Participants Retained at Post-Intervention

  MBCT feasibility will be measured by: \>75% post-intervention assessments completed

  3 Months

• Videoconferencing Feasibility: Percent of Connections Dropped During Sessions

  Videoconferencing feasibility will be assessed by: \< 20% of connections dropped during session

  6 Months

• Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Baseline

  Blood spot feasibility will be assessed by: \>75% of participants submitting samples at baseline

  6 months

• Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Sample at Post-Intervention

  Blood spot feasibility will be assessed by: \>75% of participants submitting samples at post-intervention

  6 Month

• Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Follow-up

  Blood spot feasibility will be assessed by: \>60% of participants submitting samples at follow-up

  6 Months

• Blood Spot Feasibility: Percent of Adequate Blood Spot Samples Submitted

  Blood spot feasibility will be assessed by: 80% of samples of adequate quality for processing.

  6 Months

• MBCT Acceptability: Helpfulness for Mood

  Ratings of how helpful the MBCT sessions were for improving mood (1 = not at all helpful to 10 = very helpful), with acceptability defined as Mean \>= 7.5

  6 months

• MBCT Acceptability: Usefulness of Session Components

  The average usefulness ratings for session components on a scale of 1 = not at all useful to 10 = very useful, with mean \>= 7.5 being considered acceptable

  6 months

• Videoconferencing Acceptability: Ratings of Videoconferencing Ease of Use

  Videoconferencing acceptability will be assessed in terms of ease of use (1= very much, 10 = not at all; M \>= 7.5)

  6 Months

• Videoconferencing Acceptability: Ratings of Videoconferencing Quality Surveys)

  Videoconferencing acceptability will be assessed in terms of video quality of mindfulness videoconference sessions (1= Very Poor to 10 = Very Good, M\>7.5)

  6 Months

• Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction

  Videoconferencing acceptability will be assessed in overall satisfaction of use (1 = not at all satisfied to 10 = very satisfied, M \> 7.5)

  6 Months

• Blood Spot Acceptability: Ease of Blood Spot Collection

  Blood spot acceptability will be assessed by ratings of ease of blood spot collection (1 = not at all, 10 = very easy; M\>7.5)

  Average rating for ease of data submission from blood spot collection through out all groups

• Blood Spot Acceptability: Discomfort of Blood Spot Collection

  Blood spot acceptability will be assessed by ratings of level of pain during blood spot collection, (1=Very much pain, 10=Very little pain; M\>=7.5).

  6 Months

Secondary Outcomes (1)

• Patient Health Questionnaire (PHQ-9)

  6 months

Study Arms (1)

Virtual MBCT

EXPERIMENTAL

Two cohorts of MBCT participants with approximately 10 participants per cohort.

Other: MBCT intervention for ACS patients

Interventions

MBCT intervention for ACS patients OTHER

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. Participants involved in the intervention 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 minutes).

Virtual MBCT

Eligibility Criteria

• Age: 35 Years - 85 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\>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 \< 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

MeSH Terms

Conditions

Acute Coronary Syndrome; Depression; Myocardial Infarction; Angina, Unstable; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavioral Symptoms; Behavior; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Christina Luberto, PhD
• Organization: Massachusetts General Hospital

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Approximately N=20 patients (2 cohorts of 10 participants/per cohort, accounting for 20% anticipated lost to follow-up). Assignment to each cohort will be based on timing and/or participant scheduling preferences. Intervention cohort groups will be run either concurrently or sequentially, depending on the enrollment frequency of participants.

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 18, 2020
• Study Start: April 24, 2020
• Primary Completion: February 25, 2021
• Study Completion: March 1, 2021
• Last Updated: April 24, 2023
• Results First Posted: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)