Remote-delivered MBCT for SCAD Survivors

Coronary Artery Disease Clinical Trial

Official title:

Remote-delivered Mindfulness-Based Cognitive Therapy to Target Fear of Recurrence Among SCAD Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04983680
• Other study ID #: 2021P001519
• Secondary ID: P30AG064198
• Status: Completed
• Phase: Phase 1
• Start date: November 4, 2021
• Est. completion date: June 4, 2022

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 4, 2022
• Est. primary completion date: June 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Anxiety
• Coronary Artery Disease
• Sleep

Intervention

Behavioral:
• MBCT
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.

Locations

Country	Name	City	State
United States	Mongan Institute: Health Policy Research Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Enrollment: Percent of Participants Enrolled	Feasibility will be assessed by >70% of eligible patients enroll	7 months
Primary	Feasibility of Retention: Percent of Enrolled Participants Retained at Post-intervention	Feasibility of retention will be assessed by > 70% of participants completing the post-intervention survey	7 months
Primary	Feasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Pre-intervention	Feasibility of daily diary completion will be assessed by >70% of participants completing daily diaries for 7 consecutive days at pre-intervention	7 months
Primary	Feasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Post-intervention	Feasibility of daily diary completion will be assessed by >70% of participants completing daily diaries for 7 consecutive days at post-intervention	7 months
Primary	Feasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Pre-intervention	Feasibility of actigraphy use will be assessed by >70% of participants completing actigraphy for 7 consecutive days at pre-intervention	7 months
Primary	Feasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Post-intervention	Feasibility of actigraphy use will be assessed by >70% of participants completing actigraphy for 7 consecutive days at post-intervention	7 months
Primary	Feasibility of MBCT Intervention: Participant Attendance Rates	Feasibility of UpBeat-MBCT intervention will be assessed by >70% of participants attending >6/8 sessions	7 months
Primary	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	7 months
Primary	Intervention Acceptability: Plans to Use the Skills in the Future	Intervention acceptability will be assessed by >70% plan to use the intervention skills in the future	7 months
Primary	Intervention Acceptability: Would Recommend the Program to Others	Intervention acceptability will be assessed by >70% would recommend the program to others	7 months
Primary	Intervention Acceptability: Home Practice Completion	Acceptability of the UpBeat-MBCT intervention will be assessed by >70% of participants completing home practice >3days/week	7 months
Primary	Acceptability of Daily Diary Surveys: Ease of Completion	Acceptability of daily diaries will be assessed by ease of daily diary completion (1=not at all, 10=extremely). Mean acceptability rating > 7.0 indicates acceptability	7 months
Primary	Acceptability of Daily Diary Surveys: Level of Survey Interference	Acceptability of daily diaries will be assessed by level of survey interference in daily life (1=not at all, 10=extremely, M<2.0)	7 months
Primary	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)	7 months
Secondary	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. This study used a 5 item version of the ASC, thus the scores range from 5 (lower fear of reoccurrence) to 20 (higher fear of reoccurrence). The 5 item version has two subscales: health worry, cardiac worry. Scores from each subscale are summed to achieve the final score.	7 months
Secondary	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). Each item is scored on a Likert scale from 1 (never) to 5 (all of the time); the total minimum score is 11 while the maximum score is 55. Higher scores indicate greater cognitive decentering (better outcomes), while lower scores indicate less cognitive de-centering (worse outcome)	7 months
Secondary	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. The DTS is 15 item measure where each item is scores from 1 (strongly agree) to 5 (strongly disagree). Lower scores (minimum = 1) indicate lower distress tolerance and worse outcomes. Higher scores (maximum = 5) indicate higher distress tolerance and better outcomes.	7 months
Secondary	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. Items are scored on a scale 1 (Rarely/Not at all) to 4 (Almost Always). Lower scores (minimum = 1) reflect lower trait mindfulness (worse outcome) whereas higher scores (maximum = 40) indicate higher trait mindfulness (better outcome)	7 months
Secondary	Non-judgmental Body Awareness	The body trusting subscale of 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. The minimum score on the subscale is 0 while the maximum is 10. Scores of 10 indicate higher body trusting (better outcome). Scores of 0 indicate lower body trusting (worse outcome).	7 Months
Secondary	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. The maximum score is 280, indicating high body vigilance and worse outcomes, while the minimum score is 0,indicating low body vigilance and better outcomes.	7 months
Secondary	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. The maximum score is 60 which indicates high intolerance of uncertainty and worse outcomes. The minimum score is 12 which indicates low intolerance of uncertainty and better outcomes. Each item is scored on a scale from 1 (not at all characteristic of me) to 5 (entirely characteristic of me).	7 months
Secondary	Cardiac Anxiety	Four items from the physical concerns subscale of the Anxiety Sensitivity Index 3 will be used to assess cardiac anxiety levels before and after the intervention. Items are scored on a scale from 0 (very little) to 4 (very much). The minimum possible score is 0, indicating low anxiety sensitivity and better outcomes. The maximum possible score is 16, indicating high anxiety sensitivity and worse outcomes.	7 months
Secondary	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 and will be included in the sleep diaries.	3 months
Secondary	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.	3 months