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Remote-delivered MBCT for SCAD Survivors

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04983680
Enrollment
19
Registered
2021-07-30
Start date
2021-11-04
Completion date
2022-06-04
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Anxiety, Coronary Artery Disease, Sleep

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.

Interventions

BEHAVIORALMBCT

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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of Actigraphy7 monthsAcceptability of actigraphy will be assessed by ratings of ease of actigraphy completion (1=not at all, 10 =extremely, M\>7.0)
Feasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Post-intervention7 monthsFeasibility of daily diary completion will be assessed by \>70% of participants completing daily diaries for 7 consecutive days at post-intervention
Feasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Pre-intervention7 monthsFeasibility of actigraphy use will be assessed by \>70% of participants completing actigraphy for 7 consecutive days at pre-intervention
Feasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Post-intervention7 monthsFeasibility of actigraphy use will be assessed by \>70% of participants completing actigraphy for 7 consecutive days at post-intervention
Feasibility of MBCT Intervention: Participant Attendance Rates7 monthsFeasibility of UpBeat-MBCT intervention will be assessed by \>70% of participants attending \>6/8 sessions
Feasibility of Videoconferencing Delivery: Percent of Sessions With Videoconferencing Problems7 monthsFeasibility of videoconferencing delivery will be assessed by \<20% of sessions missed due to videoconference problems
Intervention Acceptability: Plans to Use the Skills in the Future7 monthsIntervention acceptability will be assessed by \>70% plan to use the intervention skills in the future
Intervention Acceptability: Would Recommend the Program to Others7 monthsIntervention acceptability will be assessed by \>70% would recommend the program to others
Intervention Acceptability: Home Practice Completion7 monthsAcceptability of the UpBeat-MBCT intervention will be assessed by \>70% of participants completing home practice \>3days/week
Acceptability of Daily Diary Surveys: Ease of Completion7 monthsAcceptability 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
Acceptability of Daily Diary Surveys: Level of Survey Interference7 monthsAcceptability of daily diaries will be assessed by level of survey interference in daily life (1=not at all, 10=extremely, M\<2.0)
Feasibility of Enrollment: Percent of Participants Enrolled7 monthsFeasibility will be assessed by \>70% of eligible patients enroll
Feasibility of Retention: Percent of Enrolled Participants Retained at Post-intervention7 monthsFeasibility of retention will be assessed by \> 70% of participants completing the post-intervention survey
Feasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Pre-intervention7 monthsFeasibility of daily diary completion will be assessed by \>70% of participants completing daily diaries for 7 consecutive days at pre-intervention

Secondary

MeasureTime frameDescription
Cognitive De-centering7 monthsThe 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)
Distress Tolerance7 monthsThe 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.
Attention Regulation7 monthsThe 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)
Non-judgmental Body Awareness7 MonthsThe 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).
Interoceptive Bias7 monthsThe 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.
Intolerance of Uncertainty7 monthsThe 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).
Cardiac Anxiety7 monthsFour 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.
Self-reported Sleep Outcomes3 monthsSleep 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.
Self-reported Physical Activity3 monthsModerate-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.
Fear of Recurrence7 monthsThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
19
Total19

Baseline characteristics

CharacteristicMindfulness-Based Cognitive Therapy
Age, Continuous50.68 years
STANDARD_DEVIATION 9.46
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
18 Participants
Sex: Female, Male
Female
16 Participants
Sex: Female, Male
Male
1 Participants
Time Since SCAD22.74 months
STANDARD_DEVIATION 4.24

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 19
other
Total, other adverse events
1 / 19
serious
Total, serious adverse events
0 / 19

Outcome results

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)

Time frame: 7 months

ArmMeasureValue (MEAN)Dispersion
Mindfulness-Based Cognitive TherapyAcceptability of Actigraphy8.67 score on a scaleStandard Deviation 2.27
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

Time frame: 7 months

ArmMeasureValue (MEAN)Dispersion
Mindfulness-Based Cognitive TherapyAcceptability of Daily Diary Surveys: Ease of Completion7.83 score on a scaleStandard Deviation 2.21
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)

Time frame: 7 months

ArmMeasureValue (MEAN)Dispersion
Mindfulness-Based Cognitive TherapyAcceptability of Daily Diary Surveys: Level of Survey Interference3.0 score on a scaleStandard Deviation 2.59
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

Time frame: 7 months

Population: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mindfulness-Based Cognitive TherapyFeasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Post-intervention13 Participants
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

Time frame: 7 months

Population: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mindfulness-Based Cognitive TherapyFeasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Pre-intervention18 Participants
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

Time frame: 7 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mindfulness-Based Cognitive TherapyFeasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Post-intervention7 Participants
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

Time frame: 7 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mindfulness-Based Cognitive TherapyFeasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Pre-intervention13 Participants
Primary

Feasibility of Enrollment: Percent of Participants Enrolled

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

Time frame: 7 months

Population: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mindfulness-Based Cognitive TherapyFeasibility of Enrollment: Percent of Participants Enrolled19 Participants
Primary

Feasibility of MBCT Intervention: Participant Attendance Rates

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

Time frame: 7 months

Population: participants who enrolled in, and attended, group intervention sessions.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mindfulness-Based Cognitive TherapyFeasibility of MBCT Intervention: Participant Attendance Rates10 Participants
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

Time frame: 7 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mindfulness-Based Cognitive TherapyFeasibility of Retention: Percent of Enrolled Participants Retained at Post-intervention12 Participants
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

Time frame: 7 months

ArmMeasureValue (COUNT_OF_UNITS)
Mindfulness-Based Cognitive TherapyFeasibility of Videoconferencing Delivery: Percent of Sessions With Videoconferencing Problems0 Number of virtual sessions
Primary

Intervention Acceptability: Home Practice Completion

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

Time frame: 7 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mindfulness-Based Cognitive TherapyIntervention Acceptability: Home Practice Completion9 Participants
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

Time frame: 7 months

Population: Participants retained at post-intervention who answered this item on the post-survey

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mindfulness-Based Cognitive TherapyIntervention Acceptability: Plans to Use the Skills in the Future11 Participants
Primary

Intervention Acceptability: Would Recommend the Program to Others

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

Time frame: 7 months

Population: Participants retained at post-intervention who answered this item on the post-survey

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mindfulness-Based Cognitive TherapyIntervention Acceptability: Would Recommend the Program to Others10 Participants
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)

Time frame: 7 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Cognitive TherapyAttention RegulationPre-intervention31.58 score on a scaleStandard Deviation 8.74
Mindfulness-Based Cognitive TherapyAttention RegulationPost-intervention32.58 score on a scaleStandard Deviation 6.93
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.

Time frame: 7 months

Population: N=8 in post intervention due to incomplete surveys

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Cognitive TherapyCardiac AnxietyPre-intervention9.42 score on a scaleStandard Deviation 4.21
Mindfulness-Based Cognitive TherapyCardiac AnxietyPost-intervention6.83 score on a scaleStandard Deviation 4.61
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)

Time frame: 7 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Cognitive TherapyCognitive De-centeringPre-intervention32.91 score on a scaleStandard Deviation 10
Mindfulness-Based Cognitive TherapyCognitive De-centeringPost-intervention38.18 score on a scaleStandard Deviation 6.52
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.

Time frame: 7 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Cognitive TherapyDistress TolerancePre-intervention3.19 score on a scaleStandard Deviation 0.94
Mindfulness-Based Cognitive TherapyDistress TolerancePost-intervention3.39 score on a scaleStandard Deviation 0.76
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.

Time frame: 7 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Cognitive TherapyFear of RecurrencePre-intervention13.33 score on a scaleStandard Deviation 3.5
Mindfulness-Based Cognitive TherapyFear of RecurrencePost-intervention11.33 score on a scaleStandard Deviation 3.85
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.

Time frame: 7 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Cognitive TherapyInteroceptive BiasPre-intervention18.25 score on a scaleStandard Deviation 5.28
Mindfulness-Based Cognitive TherapyInteroceptive BiasPost-intervention15.08 score on a scaleStandard Deviation 5.14
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).

Time frame: 7 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Cognitive TherapyIntolerance of UncertaintyPre-intervention33.36 score on a scaleStandard Deviation 14.4
Mindfulness-Based Cognitive TherapyIntolerance of UncertaintyPost-intervention27.63 score on a scaleStandard Deviation 12.91
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).

Time frame: 7 Months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Cognitive TherapyNon-judgmental Body AwarenessPre-intervention8.0 score on a scaleStandard Deviation 5.54
Mindfulness-Based Cognitive TherapyNon-judgmental Body AwarenessPost-intervention8.7 score on a scaleStandard Deviation 4.76
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.

Time frame: 3 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Cognitive TherapySelf-reported Physical ActivityPre-Intervention33.46 hours/weekStandard Deviation 27.11
Mindfulness-Based Cognitive TherapySelf-reported Physical ActivityPost-Intervention59.50 hours/weekStandard Deviation 55.45
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.

Time frame: 3 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness-Based Cognitive TherapySelf-reported Sleep OutcomesPre-Intervention1.83 number of awakenings per nightStandard Deviation 1.11
Mindfulness-Based Cognitive TherapySelf-reported Sleep OutcomesPost-Intervention1.63 number of awakenings per nightStandard Deviation 0.92

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026