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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG064198 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Cognitive Therapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBCT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Enrollment: Percent of Participants Enrolled | Feasibility will be assessed by >70% of eligible patients enroll | 7 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina M Luberto, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mongan Institute: Health Policy Research Center | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41120129 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness-Based Cognitive Therapy | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness-Based Cognitive Therapy | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Enrollment: Percent of Participants Enrolled | Feasibility will be assessed by >70% of eligible patients enroll | The number of participants analyzed for this variable (n=20) is higher than the number who started the trial (n=19), because one person who screened eligible refused to enroll. | Posted | Count of Participants | Participants | 7 months |
|
The data were collected over 7 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness-Based Cognitive Therapy | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Event | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christina Luberto | Massachusetts General Hospital/Harvard Medical School | 617-643-9453 | cluberto@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 26, 2023 | Jun 1, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003324 | Coronary Artery Disease |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| 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 |
| 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 |
| 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 |
| Intervention Acceptability: Would Recommend the Program to Others | Intervention acceptability will be assessed by >70% would recommend the program to others | 7 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 7 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| years |
|
| Sex: Female, Male | The analysis population for gender is n=17 which differs from the overall sample (n=19) because two participants did not report their gender. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Time Since SCAD | Mean | Standard Deviation | months |
|
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| 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 7 months |
|
|
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| 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 | Posted | Count of Participants | Participants | 7 months |
|
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| 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 | Participants who received an actigraphy watch as part of the study. Note that although 19 participants were enrolled, only 18 received a watch and were included in actigraphy procedures because the study team only had 18 watches available. | Posted | Count of Participants | Participants | 7 months |
|
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| 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 | Participants who received an actigraphy watch as part of the study. Note that although 19 participants were enrolled, only 18 received a watch and were included in actigraphy procedures because the study team only had 18 watches available. | Posted | Count of Participants | Participants | 7 months |
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| Primary | Feasibility of MBCT Intervention: Participant Attendance Rates | Feasibility of UpBeat-MBCT intervention will be assessed by >70% of participants attending >6/8 sessions | participants who enrolled in, and attended, group intervention sessions. | Posted | Count of Participants | Participants | 7 months |
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| 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 | Posted | Count of Units | Number of virtual sessions | 7 months | Number of virtual sessions | Number of virtual sessions |
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| 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 | Participants retained at post-intervention who answered this item on the post-survey | Posted | Count of Participants | Participants | 7 months |
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| Primary | Intervention Acceptability: Would Recommend the Program to Others | Intervention acceptability will be assessed by >70% would recommend the program to others | Participants retained at post-intervention who answered this item on the post-survey | Posted | Count of Participants | Participants | 7 months |
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| Primary | Intervention Acceptability: Home Practice Completion | Acceptability of the UpBeat-MBCT intervention will be assessed by >70% of participants completing home practice >3days/week | Posted | Count of Participants | Participants | 7 months |
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| 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 | Posted | Mean | Standard Deviation | score on a scale | 7 months |
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| 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) | Posted | Mean | Standard Deviation | score on a scale | 7 months |
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| 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) | Posted | Mean | Standard Deviation | score on a scale | 7 months |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 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) | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 7 months |
|
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|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 7 months |
|
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| 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). | Posted | Mean | Standard Deviation | score on a scale | 7 Months |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 7 months |
|
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| 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). | Posted | Mean | Standard Deviation | score on a scale | 7 months |
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| 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. | N=8 in post intervention due to incomplete surveys | Posted | Mean | Standard Deviation | score on a scale | 7 months |
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| 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. | Posted | Mean | Standard Deviation | number of awakenings per night | 3 months |
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| 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. | Posted | Mean | Standard Deviation | hours/week | 3 months |
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| 0 |
| 19 |
| 0 |
| 19 |
| 1 |
| 19 |
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| D003327 |
| Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D001523 | Mental Disorders |
|