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

Primary Purpose

Acute Coronary Syndrome, Depression, Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MBCT intervention for ACS patients
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Mindfulness, Acute Coronary Syndrome, Videoconferencing, Depression

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Lifetime ACS per medical record and/or patient confirmation
  2. Current elevated depression symptoms (PHQ-9>5)
  3. Age 35-85 years
  4. Access to high-speed internet

Exclusion Criteria:

  1. Active suicidal ideation or past-year psychiatric hospitalization (per patient report and/or medical record review)
  2. Non-English-speaking
  3. Cognitive impairments preventing informed consent per medical record review and/or cognitive Screen < 4
  4. Patient deemed unable to complete the study protocol or has a condition that would likely interfere with the study

Sites / Locations

  • Mongan Institute: Health Policy Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual MBCT

Arm Description

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

Outcomes

Primary Outcome Measures

Recruitment Feasibility: Percent of Participants Who Consent to Screening
Feasibility outcomes for recruitment will include: >70% of patients reached consent to screening
Recruitment Feasibility: Percent of Participants Meeting Screening Criteria
Feasibility outcomes for recruitment will include: >70% meet screening criteria
Recruitment Feasibility: Percent of Eligible Patients Who Consent
Feasibility outcomes for recruitment will include: >70% of eligible consent to the study
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)
MBCT Feasibility: Percent of Participants Retained at Post-Intervention
MBCT feasibility will be measured by: >75% post-intervention assessments completed
Videoconferencing Feasibility: Percent of Connections Dropped During Sessions
Videoconferencing feasibility will be assessed by: < 20% of connections dropped during session
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
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
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
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.
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
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
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)
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)
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)
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)
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).

Secondary Outcome Measures

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

Full Information

First Posted
January 10, 2020
Last Updated
April 20, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04231097
Brief Title
MBCT Delivered Via Group Videoconferencing for ACS Syndrome Patients With Depressive Symptoms
Official Title
Mindfulness-Based Cognitive Therapy Delivered Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 24, 2020 (Actual)
Primary Completion Date
February 25, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Depression, Myocardial Infarction, Unstable Angina, STEMI, NSTEMI - Non-ST Segment Elevation MI
Keywords
Mindfulness, Acute Coronary Syndrome, Videoconferencing, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual MBCT
Arm Type
Experimental
Arm Description
Two cohorts of MBCT participants with approximately 10 participants per cohort.
Intervention Type
Other
Intervention Name(s)
MBCT intervention for ACS patients
Intervention Description
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).
Primary Outcome Measure Information:
Title
Recruitment Feasibility: Percent of Participants Who Consent to Screening
Description
Feasibility outcomes for recruitment will include: >70% of patients reached consent to screening
Time Frame
6 months
Title
Recruitment Feasibility: Percent of Participants Meeting Screening Criteria
Description
Feasibility outcomes for recruitment will include: >70% meet screening criteria
Time Frame
6 months
Title
Recruitment Feasibility: Percent of Eligible Patients Who Consent
Description
Feasibility outcomes for recruitment will include: >70% of eligible consent to the study
Time Frame
6 Months
Title
MBCT Feasibility: Percent of Participants Adherent to the MBCT Intervention
Description
MBCT feasibility will be measured by: >75% session attendance (i.e., percent who attend at least 6/8 intervention sessions)
Time Frame
6 Months
Title
MBCT Feasibility: Percent of Participants Retained at Post-Intervention
Description
MBCT feasibility will be measured by: >75% post-intervention assessments completed
Time Frame
3 Months
Title
Videoconferencing Feasibility: Percent of Connections Dropped During Sessions
Description
Videoconferencing feasibility will be assessed by: < 20% of connections dropped during session
Time Frame
6 Months
Title
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Baseline
Description
Blood spot feasibility will be assessed by: >75% of participants submitting samples at baseline
Time Frame
6 months
Title
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Sample at Post-Intervention
Description
Blood spot feasibility will be assessed by: >75% of participants submitting samples at post-intervention
Time Frame
6 Month
Title
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Follow-up
Description
Blood spot feasibility will be assessed by: >60% of participants submitting samples at follow-up
Time Frame
6 Months
Title
Blood Spot Feasibility: Percent of Adequate Blood Spot Samples Submitted
Description
Blood spot feasibility will be assessed by: 80% of samples of adequate quality for processing.
Time Frame
6 Months
Title
MBCT Acceptability: Helpfulness for Mood
Description
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
Title
MBCT Acceptability: Usefulness of Session Components
Description
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
Title
Videoconferencing Acceptability: Ratings of Videoconferencing Ease of Use
Description
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
Title
Videoconferencing Acceptability: Ratings of Videoconferencing Quality Surveys)
Description
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
Title
Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction
Description
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
Title
Blood Spot Acceptability: Ease of Blood Spot Collection
Description
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
Title
Blood Spot Acceptability: Discomfort of Blood Spot Collection
Description
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
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Luberto, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mongan Institute: Health Policy Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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