MBCT Delivered Via Group Videoconferencing for ACS Syndrome Patients With Depressive Symptoms
Condition: Acute Coronary Syndrome; Depression; Myocardial Infarction; Unstable Angina; STEMI; NSTEMI - Non-ST Segment Elevation MI
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable; Syndrome; Infarction; Depression
Study type: Interventional

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.
    

Intervention name(s): MBCT intervention for ACS patients
Intervention type(s): Other
Intervention description(s): 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).
Intervention model: Single Group Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mindfulness; Acute Coronary Syndrome; Videoconferencing; Depression