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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04231097

Collaborator

(none)

Enrollment

Location

Arm

11.2

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Depression Myocardial Infarction Unstable Angina STEMI NSTEMI - Non-ST Segment Elevation MI	Other: MBCT intervention for ACS patients	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

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.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

Official Title:

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

Actual Study Start Date :

Apr 24, 2020

Actual Primary Completion Date :

Feb 25, 2021

Anticipated Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual MBCT Two cohorts of MBCT participants with approximately 10 participants per cohort.	Other: MBCT intervention for ACS patients 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).

Arm

Intervention/Treatment

Experimental: Virtual MBCT

Two cohorts of MBCT participants with approximately 10 participants per cohort.

Other: MBCT intervention for ACS patients

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).

Outcome Measures

Primary Outcome Measures

Recruitment feasibility: percent of participants recruited and enrolled [6 months]
Feasibility outcomes for recruitment will include: >70% of patients reached consent to screening, >70% meet screening criteria, >70% of eligible enroll, and enrolling approximately N=20 participants within 1-2 months.
Eligibility feasibility: percent of participants determined eligible [6 months]
Feasibility for eligibility criteria include: <20% ineligible due to each criterion, reasons for ineligibility, reasons for refusal, and characteristics of refusers.
MBCT feasibility: Percent of participants adherent to the MBCT intervention [6 months]
MBCT feasibility will be measured by: >75% session attendance, >75% post-assessments completed, >70% follow-up assessments completed, fidelity checklist score >80%, and >75% complete home practice at least 3 days/week.
Videoconferencing feasibility: number and type of videoconferencing difficulties [6 months]
Videoconferencing feasibility will be assessed by: < 20% of connections dropped during session; <20% of sessions missed due to technical problems; number (Mean <2.0) and types of problems, <20% ask for extra training and type of extra training needed.
Blood spot feasibility: rate of adequate blood spot sample completion [6 months]
Blood spot feasibility will be assessed by >75% of samples submitted at baseline and post-intervention, >60% submitted at follow-up, and 80% of samples of adequate quality.
MBCT acceptability: ratings of intervention satisfaction [6 months]
MBCT acceptability will be assessed by average scores >7.5 on ratings of session helpfulness, enjoyment, relevance, and utility of session components (scale of 1 = not at all to 10 = very much).
Videoconferencing acceptability: ratings of videoconferencing satisfaction [6 months]
Videoconferencing acceptability will be assessed in terms of ease and confidence of use (1 = not at all to 10 = extremely, M > 7.5), interference of technical problems (1= none to 10 = extreme, M<2.0), audiovisual quality and overall satisfaction (1= poor to 10 = excellent, M>7.5), and themes related to pros and cons and suggestions for improvement in the exit interviews.
Blood spot acceptability: blood spot collection ease and comfort [6 months]
Blood spot acceptability will be assessed by ratings of ease of data collection and submission (1 = not at all, 10 = extremely; M > 7.5), level of pain (1 = none, 10 = extreme, M < 2.0), and concerns and suggestions for improvement expressed in the exit interview.

Secondary Outcome Measures

Patient Health Questionnaire (PHQ-9) [6 months]
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.
Five Factor Mindfulness Questionnaire- 15 item (FFMQ-15) [6 months]
This is a 15-item measure that measures mindfulness.This scale has five sub-scales: observing, describing, acting with awareness, non-judging, and non-reactivity. The scoring scale ranges from 1, never or very rarely true to 5, very often or always true. Scale values range from 3-15 for each sub-scale, with higher values representing greater levels of individual mindfulness and lower values representing lowers levels of individual mindfulness. Data collection for this measurement is longitudinal , and is performed during 30-90 minute time intervals one week before and after the intervention and at 3 months post-intervention.
The Positive and Negative Affect Schedule-Positive Affect (PANAS-PA) [6 months]
This is a 10-question scale, composed of 1, 10-item scale that measures positive affect. The scoring scale ranges from 1, very slightly or not at all, to 5, extremely. The scale values range from 10-50. Higher values on the positive affect scale represent higher levels of positive affect. Data collection for this measurement is longitudinal , and is performed during 30-90 minute time intervals one week before and after the intervention and at 3 months post-intervention.
Rumination Response Scale (RRS) [6 months]
This is a 22-item scale that measures rumination. The scoring scale ranges from 1,almost never, to 4, almost always. The score values range from 22 to 88, where higher values represent higher levels of rumination and lower values represent lower levels of rumination. Data collection for this measurement is longitudinal , and is performed during 30-90 minute time intervals one week before and after the intervention and at 3 months post-intervention.
Self-Other Four Immeasurables (SOFI) [6 months]
This is a 16-item scale that measures loving kindness, compassion, joy and acceptance towards self and others. This scale consists of four sub-scales: positive self, negative self, positive other, and negative other. The scoring scale ranges from 1, very slightly or not at all to 5, extremely, with sub-scale values ranging from 4-16. For this intervention, only the positive self and positive other sub-scales will be used. Data collection for this measurement is longitudinal , and is performed during 30-90 minute time intervals.
Interpersonal Reactivity Index (IRI) [6 months]
This is a 28-item scale that measures empathy. The scoring scale ranges from 0, does not describe me well, to 4, describes me very well. The score values range from 0-56, where high values represent higher levels of empathy and lower values represent lower levels of empathy. For this intervention, the two 7-item, sub-scales, emphatic concern and perspective, will be used. Data collection for this measurement is longitudinal , and is performed during 30-90 minute time intervals one week before and after the intervention and at 3 months post-intervention.
one item from the Short Form-12 (SF-12) [6 months]
We will use the first item from the validated SF-12 to assess overall perceived health. The scoring scale for item 1 ranges from 1, excellent to 5, poor. Higher values represent a higher quality of life and lower values represent a lower quality of life. Data collection for this measurement is longitudinal , and is performed during 30-90 minute time intervals one week before and after the intervention and at 3 months post-intervention.
PROMIS Physical Function (PROMIS-PF) [6 months]
This is a 4-item scale that measures and evaluates physical health. The scoring scale ranges from 5, without any difficulty, to 1, unable to do. The scoring values range from 4-20, where high values represent good physical function and low values represent poor physical function. Data collection for this measurement is longitudinal , and is performed during 30-90 minute time intervals one week before and after the intervention and at 3 months post-intervention.
Hospital Anxiety and Depression Scale (HADS) [6 months]
The Hospital Anxiety and Depression Scale (HADS)14-item measure assessing anxiety and depression symptoms in medical patients. The HADS is composed of 2, 7-item sub-scales, with scoring scales ranging from 0-3. The scoring values range from 0-42, with higher scores indicating elevated depression and anxiety symptoms. Data collection for this measurement is longitudinal , and is performed during 30-90 minute time intervals one week before and after the intervention and at 3 months post-intervention.
Current Experiences Scale (CES) [6 months]
The Current Experiences Scale (CES) is a 25-item scale assessing resilience. Scoring scales range from 0 to 5. The scoring values range from 0-125, with lower values indicating less resilience and higher values indicating more resilience. Data collection for this measurement is longitudinal , and is performed during 30-90 minute time intervals one week before and after the intervention and at 3 months post-intervention.
Expectancy Questionnaire (EQ) [6 months]
The Expectancy Questionnaire (EQ) is a 2-item measure assessing expectations about the intervention's utility. Data collection for this measurement is longitudinal , and is performed during 30-90 minute time intervals one week before and after the intervention and at 3 months post-intervention.
COVID Items [6 months]
The COVID Items are a set of questions assessing COVID-related concerns. This measure is researcher-developed based on validated measures of health anxiety. The items will be used to assess baseline concerns and possible changes associated with participation in MBCT.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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