AzTrials
AzTrials

Acute Coronary SyndromePhase 1NCT04983680

Remote-delivered MBCT for SCAD Survivors

A Phase 1 study testing MBCT in people with Acute Coronary Syndrome and Coronary Artery Disease, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MBCT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
4 Nov 2021to 4 Jun 2022
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mongan Institute: Health Policy Research Center

    Boston, Massachusetts, 02114

Other trials in United States

About this study

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

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.

Being tested
MBCT
Medical subject headings
Acute Coronary Syndrome, Coronary Artery Disease, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MBCTBehavioural

    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.

Study groups in NCT04983680
Study groupRoleWhat they receive
Mindfulness-Based Cognitive TherapyExperimentalMindfulness-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.
Receives: Behavioral: MBCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Enrollment: Percent of Participants Enrolled

    Feasibility will be assessed by >70% of eligible patients enroll

    Measured: 7 months

  2. 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

    Measured: 7 months

  3. 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

    Measured: 7 months

  4. 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

    Measured: 7 months

  5. 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

    Measured: 7 months

  6. 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

    Measured: 7 months

  7. Feasibility of MBCT Intervention: Participant Attendance Rates

    Feasibility of UpBeat-MBCT intervention will be assessed by >70% of participants attending >6/8 sessions

    Measured: 7 months

  8. 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

    Measured: 7 months

  9. 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

    Measured: 7 months

  10. Intervention Acceptability: Would Recommend the Program to Others

    Intervention acceptability will be assessed by >70% would recommend the program to others

    Measured: 7 months

  11. Intervention Acceptability: Home Practice Completion

    Acceptability of the UpBeat-MBCT intervention will be assessed by >70% of participants completing home practice >3days/week

    Measured: 7 months

  12. 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

    Measured: 7 months

  13. 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)

    Measured: 7 months

  14. 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)

    Measured: 7 months

Secondary outcomes (10)

  1. 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.

    Measured: 7 months

  2. 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)

    Measured: 7 months

  3. 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.

    Measured: 7 months

  4. 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)

    Measured: 7 months

  5. 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).

    Measured: 7 Months

  6. 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.

    Measured: 7 months

  7. 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).

    Measured: 7 months

  8. 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.

    Measured: 7 months

  9. 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.

    Measured: 3 months

  10. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2021
  2. Study start4 Nov 2021
  3. Primary completion4 Jun 2022
  4. Study completion4 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04983680
Sponsor's protocol ID
2021P001519
Other IDs
P30AG064198
Status last verified
Aug 2024
First submitted
13 Jul 2021
Last updated
19 Sep 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Luberto CM, Lopes M, Cloutier JG, Hall DL, Wood M, Schuman-Olivier Z, Hoeppner BB, Park ER. Remotely delivered mindfulness-based cognitive therapy for spontaneous coronary artery dissection survivors. Transl Behav Med. 2025 Jan 16;15(1):ibaf064. doi: 10.1093/tbm/ibaf064.

    PubMed 41120129

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MBCT in people with Acute Coronary Syndrome and Coronary Artery Disease, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Enrollment: Percent of Participants Enrolled (time frame: 7 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04983680, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in