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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
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).
Mongan Institute: Health Policy Research Center
Boston, Massachusetts, United States
Recruitment Feasibility: Percent of Participants Who Consent to Screening
Feasibility outcomes for recruitment will include: \>70% of patients reached consent to screening
Time frame: 6 months
Recruitment Feasibility: Percent of Participants Meeting Screening Criteria
Feasibility outcomes for recruitment will include: \>70% meet screening criteria
Time frame: 6 months
Recruitment Feasibility: Percent of Eligible Patients Who Consent
Feasibility outcomes for recruitment will include: \>70% of eligible consent to the study
Time frame: 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)
Time frame: 6 Months
MBCT Feasibility: Percent of Participants Retained at Post-Intervention
MBCT feasibility will be measured by: \>75% post-intervention assessments completed
Time frame: 3 Months
Videoconferencing Feasibility: Percent of Connections Dropped During Sessions
Videoconferencing feasibility will be assessed by: \< 20% of connections dropped during session
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 6 Months
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
Time frame: 6 months
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