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Remote-delivered MBCT for SCAD Survivors

Primary Purpose

Acute Coronary Syndrome, Coronary Artery Disease, Anxiety

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MBCT
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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >18 years
  • Cardiologist-confirmed diagnosis of SCAD in the past 1-12 months
  • English-speaking and reading
  • Internet access (via computer or mobile device).

Exclusion Criteria:

  • Terminal illness with life expectancy <1 year
  • Severe mental illness requiring urgent psychiatric intervention (e.g., active suicidal ideation) or past-year psychiatric hospitalization)
  • Significant cognitive impairment preventing informed consent determined by study staff or medical record review (e.g., medical history of cognitive impairment)
  • Deemed unable to complete research procedures (e.g., group sessions or surveys) per clinical judgment of study staff
  • Unavailable for intervention sessions (e.g., schedule conflicts)

Sites / Locations

  • Mongan Institute: Health Policy Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness-Based Cognitive Therapy

Arm Description

Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week group intervention (1.5-hour weekly sessions) that combines cognitive-behavioral therapy and mindfulness training to treat emotional problems.

Outcomes

Primary Outcome Measures

Feasibility of enrollment: percent of participants enrolled
Feasibility will be assessed by >70% of eligible patients enroll and <20% ineligible due to each criterion
Feasibility of retention: percent of enrolled participants retained at post-intervention
Feasibility of retention will be assessed by <20% participant attrition
Feasibility of survey completion: percent of participants who complete the study surveys
Feasibility of survey completion will be assessed by >70 pre-intervention and post-intervention surveys completed, >70% daily diaries completed for 7 consecutive days, <20% missing data on daily diaries
Feasibility of actigraphy use: percent of participants who adhere to actigraphy procedures
Feasibility of actigraphy use will be assessed by >70% completed for 7 consecutive days
Feasibility of MBCT intervention: participant attendance rates
Feasibility of UpBeat-MBCT intervention components will be assessed by >70% session attendance
Feasibility of videoconferencing delivery: percent of sessions with videoconferencing problems
Feasibility of videoconferencing delivery will be assessed by <20% of sessions missed due to videoconference problems and <20% connections dropped during session
Acceptability of study surveys
Acceptability of surveys and daily diaries will be assessed by ease of survey completion (1=not at all, 10=extremely, M<7.0) and level of survey interference in daily life (1=not at all, 10=extremely, M<2.0)
Acceptability of actigraphy
Acceptability of actigraphy will be assessed by ratings of ease of actigraphy completion (1=not at all, 10 =extremely, M>7.0)
Intervention home practice completion
Acceptability of the UpBeat-MBCT intervention will be assessed by >70% of home practice completed <3days/week
Intervention content acceptability
Intervention acceptability will be assessed by >70% plan to use the skills and would recommend the program to others
Intervention perspectives
Intervention perspectives will be assessed by likes, dislikes, and suggestions for program improvement reported in the exit interview

Secondary Outcome Measures

Non-judgmental body awareness
The multidimensional assessment of interoceptive awareness, a validated self-report survey, will be used to explore levels of non-judgmental body awareness before and after the intervention, including daily diaries
Attention regulation
The Cognitive Affective Mindfulness Scale-Revised, a validated self-report survey, will be used to explore levels of trait mindfulness before and after the intervention, including daily diaries
Cognitive de-centering
The Experiences Questionnaire, a validated self-report survey, will be used to explore levels of trait cognitive de-centering before and after the intervention (i.e., the ability to notice mental events as transient objects separate from the self), including daily diaries
Distress tolerance
The Distress Tolerance Scale, a validated self-report survey, will be used to explore levels of the ability to withstand negative emotional states before and after the intervention, including daily diaries
Interoceptive bias
The Body Vigilance Scale, a validated self-report survey, will be used to explore attentional bias, hypervigilance, and sensitivity toward physical sensations around the chest before and after the intervention, including daily diaries
Intolerance of uncertainty
The Intolerance of Uncertainty Scale-12, a validated self-report survey, will be used to explore the ability to tolerate uncertainty before and after the intervention, including daily diaries
Fear of recurrence
The Assessment of Survivor Concerns, a validated self-report survey, will be used to explore the severity of fears of recurrent cardiac events before and after the intervention, including daily diaries
Self-reported sleep outcomes
Sleep duration, sleep efficiency, and sleep onset latency will be assessed by self-report survey via the Consensus Sleep Diary before and after the intervention, including daily diaries
Actigraphy sleep outcomes
Sleep duration, sleep efficiency, and sleep onset latency will be assessed via Actigraphy (7 consecutive days before and after the intervention)
Self-reported physical activity
Moderate-vigorous physical activity engagement will be assessed by self-report survey via the Physical Activity Vital sign before and after the intervention, including daily diaries
Actigraphy physical activity outcomes
Moderate-vigorous physical activity, total steps, and sedentary time will be assessed via Actigraphy (7 consecutive days)

Full Information

First Posted
July 13, 2021
Last Updated
March 14, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04983680
Brief Title
Remote-delivered MBCT for SCAD Survivors
Official Title
Remote-delivered Mindfulness-Based Cognitive Therapy to Target Fear of Recurrence Among SCAD Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 4, 2021 (Actual)
Primary Completion Date
June 7, 2022 (Actual)
Study Completion Date
June 7, 2022 (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
Spontaneous coronary artery dissection (SCAD) is an important cause of cardiac events, primarily affecting young healthy women with no cardiovascular risk factors. The 10-year recurrence rate is 30%, but SCAD recurrence cannot be predicted. Approximately half of SCAD survivors struggle with significant anxiety and fear of recurrence (FOR), which contributes to poor sleep and physical inactivity and, thereby, increased risk of recurrence. Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week group intervention with evidence to improve FOR and health behaviors (sleep, physical activity), through psychological mechanisms that directly target key FOR processes (interoceptive bias, intolerance of uncertainty). I adapted MBCT to target FOR, sleep, and physical activity in cardiac event survivors via group videoconferencing delivery (UpBeat-MBCT), however this intervention has not yet been targeted to SCAD survivors. I propose an open pilot trial to test the feasibility, acceptability, and changes in psychological and behavioral health variables in SCAD survivors participating in UpBeat-MBCT (N=16). Participants will be recruited from the MGH SCAD Program and asked to complete self-report surveys and actigraphy before and after the intervention. The primary outcomes are feasibility and acceptability of the intervention and research procedures. Exploratory outcomes are changes in psychological and behavioral variables and their inter-correlations. This project would be the first and only behavioral intervention for SCAD survivors and would provide preliminary data for an NIH Stage II efficacy trial to develop an accessible and efficacious intervention for a vulnerable group of SCAD survivors, with generalizability to survivors of other cardiac events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Coronary Artery Disease, Anxiety, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Cognitive Therapy
Arm Type
Experimental
Arm Description
Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week group intervention (1.5-hour weekly sessions) that combines cognitive-behavioral therapy and mindfulness training to treat emotional problems.
Intervention Type
Behavioral
Intervention Name(s)
MBCT
Intervention Description
Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week group intervention (1.5-hour weekly sessions) that combines cognitive-behavioral therapy and mindfulness training. In this study, MBCT has been adapted to include education about cardiac health and fear of recurrence, and the intervention is delivered remotely via synchronous group videoconference. There is 15-20 minutes of daily mindfulness practice between sessions. Participants are provided a home practice record form and asked to submit the completed form to study staff each week.
Primary Outcome Measure Information:
Title
Feasibility of enrollment: percent of participants enrolled
Description
Feasibility will be assessed by >70% of eligible patients enroll and <20% ineligible due to each criterion
Time Frame
1 year
Title
Feasibility of retention: percent of enrolled participants retained at post-intervention
Description
Feasibility of retention will be assessed by <20% participant attrition
Time Frame
1 year
Title
Feasibility of survey completion: percent of participants who complete the study surveys
Description
Feasibility of survey completion will be assessed by >70 pre-intervention and post-intervention surveys completed, >70% daily diaries completed for 7 consecutive days, <20% missing data on daily diaries
Time Frame
1 year
Title
Feasibility of actigraphy use: percent of participants who adhere to actigraphy procedures
Description
Feasibility of actigraphy use will be assessed by >70% completed for 7 consecutive days
Time Frame
1 year
Title
Feasibility of MBCT intervention: participant attendance rates
Description
Feasibility of UpBeat-MBCT intervention components will be assessed by >70% session attendance
Time Frame
1 year
Title
Feasibility of videoconferencing delivery: percent of sessions with videoconferencing problems
Description
Feasibility of videoconferencing delivery will be assessed by <20% of sessions missed due to videoconference problems and <20% connections dropped during session
Time Frame
1 year
Title
Acceptability of study surveys
Description
Acceptability of surveys and daily diaries will be assessed by ease of survey completion (1=not at all, 10=extremely, M<7.0) and level of survey interference in daily life (1=not at all, 10=extremely, M<2.0)
Time Frame
1 year
Title
Acceptability of actigraphy
Description
Acceptability of actigraphy will be assessed by ratings of ease of actigraphy completion (1=not at all, 10 =extremely, M>7.0)
Time Frame
1 year
Title
Intervention home practice completion
Description
Acceptability of the UpBeat-MBCT intervention will be assessed by >70% of home practice completed <3days/week
Time Frame
1 year
Title
Intervention content acceptability
Description
Intervention acceptability will be assessed by >70% plan to use the skills and would recommend the program to others
Time Frame
1 year
Title
Intervention perspectives
Description
Intervention perspectives will be assessed by likes, dislikes, and suggestions for program improvement reported in the exit interview
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Non-judgmental body awareness
Description
The multidimensional assessment of interoceptive awareness, a validated self-report survey, will be used to explore levels of non-judgmental body awareness before and after the intervention, including daily diaries
Time Frame
1 year
Title
Attention regulation
Description
The Cognitive Affective Mindfulness Scale-Revised, a validated self-report survey, will be used to explore levels of trait mindfulness before and after the intervention, including daily diaries
Time Frame
1 year
Title
Cognitive de-centering
Description
The Experiences Questionnaire, a validated self-report survey, will be used to explore levels of trait cognitive de-centering before and after the intervention (i.e., the ability to notice mental events as transient objects separate from the self), including daily diaries
Time Frame
1 year
Title
Distress tolerance
Description
The Distress Tolerance Scale, a validated self-report survey, will be used to explore levels of the ability to withstand negative emotional states before and after the intervention, including daily diaries
Time Frame
1 year
Title
Interoceptive bias
Description
The Body Vigilance Scale, a validated self-report survey, will be used to explore attentional bias, hypervigilance, and sensitivity toward physical sensations around the chest before and after the intervention, including daily diaries
Time Frame
1 year
Title
Intolerance of uncertainty
Description
The Intolerance of Uncertainty Scale-12, a validated self-report survey, will be used to explore the ability to tolerate uncertainty before and after the intervention, including daily diaries
Time Frame
1 year
Title
Fear of recurrence
Description
The Assessment of Survivor Concerns, a validated self-report survey, will be used to explore the severity of fears of recurrent cardiac events before and after the intervention, including daily diaries
Time Frame
1 year
Title
Self-reported sleep outcomes
Description
Sleep duration, sleep efficiency, and sleep onset latency will be assessed by self-report survey via the Consensus Sleep Diary before and after the intervention, including daily diaries
Time Frame
1 year
Title
Actigraphy sleep outcomes
Description
Sleep duration, sleep efficiency, and sleep onset latency will be assessed via Actigraphy (7 consecutive days before and after the intervention)
Time Frame
1 year
Title
Self-reported physical activity
Description
Moderate-vigorous physical activity engagement will be assessed by self-report survey via the Physical Activity Vital sign before and after the intervention, including daily diaries
Time Frame
1 year
Title
Actigraphy physical activity outcomes
Description
Moderate-vigorous physical activity, total steps, and sedentary time will be assessed via Actigraphy (7 consecutive days)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >18 years Cardiologist-confirmed diagnosis of SCAD in the past 1-12 months English-speaking and reading Internet access (via computer or mobile device). Exclusion Criteria: Terminal illness with life expectancy <1 year Severe mental illness requiring urgent psychiatric intervention (e.g., active suicidal ideation) or past-year psychiatric hospitalization) Significant cognitive impairment preventing informed consent determined by study staff or medical record review (e.g., medical history of cognitive impairment) Deemed unable to complete research procedures (e.g., group sessions or surveys) per clinical judgment of study staff Unavailable for intervention sessions (e.g., schedule conflicts)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina M 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

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Remote-delivered MBCT for SCAD Survivors

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