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

Not Applicable

Completed

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

Interventions: Other: MBCT intervention for ACS patients

Registration Number: NCT04231097

Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description: The current study will employ an open pilot trial to determine the initial feasibility and acceptability of a targeted, virtual MBCT intervention for ACS patients. The investigators plan to enroll approximately N=20 patients (2 cohorts of 10 participants/per cohort, accounting for 20% anticipated lost to follow-up). 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 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).

Participants will be recruited through the 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 a written consent with study staff prior to enrollment.

Participants will be enrolled in one of two MBCT intervention cohorts and expected to participate in 8-weekly, 1.5-hour virtual sessions, in conjunction with approximately 30 minutes of at-home daily practice. A licensed mental health provider (e.g., LICSW, PhD) trained in the MBCT protocol will deliver the intervention. The MBCT intervention will be delivered Zoom, a 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 home practice logs submitted between each intervention session. Primary outcomes for the intervention are feasibility and acceptability. Data collected from the study will be used to assist in the development of future RCTs.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual MBCT	MBCT intervention for ACS patients	Two cohorts of MBCT participants with approximately 10 participants per cohort.

Primary Outcome Measures

Name	Time	Method
Recruitment Feasibility: Percent of Participants Who Consent to Screening	6 months	Feasibility outcomes for recruitment will include: \>70% of patients reached consent to screening
Recruitment Feasibility: Percent of Participants Meeting Screening Criteria	6 months	Feasibility outcomes for recruitment will include: \>70% meet screening criteria
MBCT Feasibility: Percent of Participants Adherent to the MBCT Intervention	6 Months	MBCT feasibility will be measured by: \>75% session attendance (i.e., percent who attend at least 6/8 intervention sessions)
Videoconferencing Feasibility: Percent of Connections Dropped During Sessions	6 Months	Videoconferencing feasibility will be assessed by: \< 20% of connections dropped during session
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Follow-up	6 Months	Blood spot feasibility will be assessed by: \>60% of participants submitting samples at follow-up
Blood Spot Feasibility: Percent of Adequate Blood Spot Samples Submitted	6 Months	Blood spot feasibility will be assessed by: 80% of samples of adequate quality for processing.
Recruitment Feasibility: Percent of Eligible Patients Who Consent	6 Months	Feasibility outcomes for recruitment will include: \>70% of eligible consent to the study
MBCT Feasibility: Percent of Participants Retained at Post-Intervention	3 Months	MBCT feasibility will be measured by: \>75% post-intervention assessments completed
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Sample at Post-Intervention	6 Month	Blood spot feasibility will be assessed by: \>75% of participants submitting samples at post-intervention
MBCT Acceptability: Usefulness of Session Components	6 months	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
Videoconferencing Acceptability: Ratings of Videoconferencing Ease of Use	6 Months	Videoconferencing acceptability will be assessed in terms of ease of use (1= very much, 10 = not at all; M \>= 7.5)
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Baseline	6 months	Blood spot feasibility will be assessed by: \>75% of participants submitting samples at baseline
Videoconferencing Acceptability: Ratings of Videoconferencing Quality Surveys)	6 Months	Videoconferencing acceptability will be assessed in terms of video quality of mindfulness videoconference sessions (1= Very Poor to 10 = Very Good, M\>7.5)
Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction	6 Months	Videoconferencing acceptability will be assessed in overall satisfaction of use (1 = not at all satisfied to 10 = very satisfied, M \> 7.5)
MBCT Acceptability: Helpfulness for Mood	6 months	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
Blood Spot Acceptability: Ease of Blood Spot Collection	Average rating for ease of data submission from blood spot collection through out all groups	Blood spot acceptability will be assessed by ratings of ease of blood spot collection (1 = not at all, 10 = very easy; M\>7.5)
Blood Spot Acceptability: Discomfort of Blood Spot Collection	6 Months	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).

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9)	6 months	This is a 9-item scale that measures depression. The scoring scale ranges from 0, not at all, to 3, nearly every day. The scoring values range from 0-18, where high values represent higher levels of depression and lower values represent lower levels of depression. Changes of \>= 3 points from before to after the intervention represent clinically meaningful change. The outcome is the % of participants who report clinically meaningful change