Clinical trial NCT04231097: MBCT Delivered Via Group Videoconferencing for ACS Syndrome Patients With Depressive Symptoms
Official title: Mindfulness-Based Cognitive Therapy Delivered Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Depression
Myocardial Infarction
Unstable Angina
STEMI
NSTEMI - Non-ST Segment Elevation MI
Keywords: Mindfulness
Acute Coronary Syndrome
Videoconferencing
Depression
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 8
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Lifetime ACS per medical record and/or patient confirmation
2. Current elevated depression symptoms (PHQ-9\>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 \< 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 Who Consent to Screening
timeFrame: 6 months
measure: Recruitment Feasibility: Percent of Participants Meeting Screening Criteria
timeFrame: 6 months
measure: Recruitment Feasibility: Percent of Eligible Patients Who Consent
timeFrame: 6 Months
measure: MBCT Feasibility: Percent of Participants Adherent to the MBCT Intervention
timeFrame: 6 Months
measure: MBCT Feasibility: Percent of Participants Retained at Post-Intervention
timeFrame: 3 Months
measure: Videoconferencing Feasibility: Percent of Connections Dropped During Sessions
timeFrame: 6 Months
measure: Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Baseline
timeFrame: 6 months
measure: Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Sample at Post-Intervention
timeFrame: 6 Month
measure: Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Follow-up
timeFrame: 6 Months
measure: Blood Spot Feasibility: Percent of Adequate Blood Spot Samples Submitted
timeFrame: 6 Months
measure: MBCT Acceptability: Helpfulness for Mood
timeFrame: 6 months
measure: MBCT Acceptability: Usefulness of Session Components
timeFrame: 6 months
measure: Videoconferencing Acceptability: Ratings of Videoconferencing Ease of Use
timeFrame: 6 Months
measure: Videoconferencing Acceptability: Ratings of Videoconferencing Quality Surveys)
timeFrame: 6 Months
measure: Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction
timeFrame: 6 Months
measure: Blood Spot Acceptability: Ease of Blood Spot Collection
timeFrame: Average rating for ease of data submission from blood spot collection through out all groups
measure: Blood Spot Acceptability: Discomfort of Blood Spot Collection
timeFrame: 6 Months
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 6 months
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: