MBCT Delivered Via Group Videoconferencing for ACS Patients With Elevated Depression 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; Depressive Disorder
Study type: Interventional

Summary: 
      The objective of this study is to identify Acute Coronary Syndromes (ACS) patients' specific
      needs and preferences for depression treatment via in-person or virtual individual interviews
      to (a) guide MBCT adaptation; and identify barriers and facilitators to (b) group
      videoconferencing delivery, and (c) blood spot data collection to enhance feasibility.
      Through qualitative measures participants will report specific physical, cognitive, and
      behavioral symptoms to be targeted in the intervention, discuss barriers and facilitators to
      participating in a video-conference treatment program and completing blood spot data
      collection procedures.
    

Detailed description: 
      This is a qualitative research study that will involve individual interviews of ACS patients
      with elevated depression symptoms (stratified by time since ACS [≤2 years and >2 years post
      ACS]; N=10 participants per strata) to explore patients' treatment needs and preferences for
      an adapted MBCT intervention, and barriers and facilitators for future intervention research
      procedures (i.e., videoconferencing delivery of the intervention and collection of dried
      blood spots). It will also involve individual interviews of ACS patients without elevated
      depression symptoms (N=10) to better understand the needs of ACS patients who are interested
      in treatment but not currently depressed, in order to inform future outreach and treatment
      development efforts (total N=30). Interviews will be conducted either in person, by phone, or
      by video conference.

      Participants will be recruited in several ways. First, participants will be identified using
      the MGH Research Patient Data Registry (RPDR). Participants will be pre-screened for
      eligibility and sent an opt-out letter. Patients will have the option to opt out via phone or
      email. Patients who do not opt out and meet eligibility requirements will be contacted via
      phone. Over the phone, patients who express interest in the study will complete an
      eligibility screen; patients who meet study eligibility criteria will then complete a verbal
      consent to enroll in the study. Second, patients will be recruited through advertisements
      (e.g., flyers, brochures) placed throughout inpatient and/or outpatient hospital clinics,
      community mental health clinics, community businesses (e.g. coffee shops) and social media
      platforms. The advertisements will ask patients to contact study staff if they are interested
      in learning more about the study, and the screening procedures will be the same as those
      described above for RPDR patients. Lastly, patients will be recruited via direct referrals
      from their providers (e.g., cardiologists, psychiatrists). We will inform providers about the
      study (e.g., via short presentations at their team meetings) and provide them with
      advertisement materials to give to their patients. The patients may either contact study
      staff directly using the information their provider gave them, and/or the provider will
      contact the study team with the patient's information so that the study team may reach out to
      the patient. Providers will obtain verbal permission from the patient for the research team
      to contact them.

      Once enrolled, participants will partake in a semi-structured in-person individual interview.
      Individual interviews will be stratified by time since ACS and depressive symptoms and will
      explore (a) emotional symptoms; (b) health behavior challenges; (c) specific preferences for
      the MBCT intervention; and (d) potential barriers and facilitators of group videoconferencing
      and (e) blood spot data collection. Participants will also complete a survey detailing
      depression symptoms, trait mindfulness, health behaviors, and other psychological,
      behavioral, and physical constructs that may potentially be impacted by the MBCT intervention
      in subsequent trials will be measured. Data collected from the individual interviews will be
      used to guide MBCT adaptations and research procedures for future clinical trials.
    

Intervention name(s): Individual Interview
Intervention type(s): Other
Intervention description(s): Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Approximately 20 individual interviews of ACS patients with elevated depression symptoms stratified by time since ACS (e.g. within the past 2 years or greater than 2 years ago), with 10 participants per strata. There will be approximately 10 individual interviews with ACS patients who are interested in treatment but not currently depressed.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Mindfulness; Acute Coronary Syndrome; Videoconferencing; Depression