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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mindfulness-Based Cognitive Therapy Delivered Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms

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

Intervention / Treatment
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* Other: MBCT intervention for ACS patients


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual MBCT<br>Two cohorts of MBCT participants with approximately 10 participants per cohort. | Other: MBCT intervention for ACS patients<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (PHQ-9) | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Acute Coronary Syndrome, Videoconferencing, Depression