Trial Outcomes & Findings for Mind Your Heart Study (NCT NCT03571581)

NCT ID: NCT03571581

Last Updated: 2025-07-14

Results Overview

Percentage of participants retained in the study (n enrolled/n retained X 100)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: 3 months, 6 months
• Results posted on: 2025-07-14

Participant Flow

Participant milestones

Measure	Mindfulness Training (MT) Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 20 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Overall Study STARTED	33
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Mindfulness Training (MT) Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 20 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Overall Study Death	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Mind Your Heart Study

Baseline characteristics by cohort

Measure	Mindfulness Training (MT) n=33 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants were instructed to practice mindfulness techniques for 20 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Age, Continuous	60.3 Years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months, 6 months

Population: 1 participant withdrew from the study and 1 died before the intervention started; these participants were not include in final analyses.

Percentage of participants retained in the study (n enrolled/n retained X 100)

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Retention Rate 3 months	31 Participants
Retention Rate 6 months	29 Participants

PRIMARY outcome

Timeframe: 3 months

Self-reported intervention enjoyment scale (1 = did not enjoy to 5 = enjoyed very much). Scores range from 1 to 5; higher scores mean a better outcome. The metric for this study was the percentage of participants indicating high intervention enjoyment (a score of 5).

Outcome measures

Measure

Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.

Intervention Acceptability

24 Participants

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months

The Voils extent of non-adherence scale ranges from 1-5. Higher scores represent greater non-adherence.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Self-reported Medication Adherence Baseline	2.8 score on a scale Standard Deviation 2.6
Self-reported Medication Adherence 3 months	2.6 score on a scale Standard Deviation 0.6
Self-reported Medication Adherence 6 months	2.6 score on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months

Medication Event Monitoring Systems (MEMS). Proportion of medication taken/medication prescribed x 100, averaged over 30 days. Range is 0-100%. Lower values indicate worse adherence.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Objectively-assessed Medication Adherence Baseline	73 percentage of meds taken/prescrib Standard Deviation 28
Objectively-assessed Medication Adherence 3 months	58 percentage of meds taken/prescrib Standard Deviation 35
Objectively-assessed Medication Adherence 6 months	61 percentage of meds taken/prescrib Standard Deviation 37

SECONDARY outcome

Timeframe: baseline, 3 months, 6 months

6-min walk test (6MWT) distance. The 6 min walk test measures the distance a patient can walk on a level course in 6 min. It is a measure of functional capacity that correlates with peak oxygen uptake and is positively associated with survival in patients with cardiovascular disease. A higher value (in meters) indicates better functional capacity. The 6MWT distance in healthy adults has been reported to range from 400 to 700 meters.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Functional Capacity baseline	350 meters Standard Deviation 93
Functional Capacity 3 months	378 meters Standard Deviation 97
Functional Capacity 6 months	374 meters Standard Deviation 95

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

Cognitive function was assessed using the NIH Toolbox Fluid Cognition Battery. Each neurocognitive test was independently completed by study participants (3-5 minutes each) using a study tablet after a baseline practice trial. For each cognitive measure we report age-adjusted scores, which are automatically generated by the NIH Toolbox software. For all measures, higher scores indicate better cognitive performance.

The Flanker Inhibitory Control and Attention Test is a measure of executive function, attention and inhibitory control. Participants are instructed to focus on a stimulus while inhibiting attention to another stimulus (arrows). Sometimes the middle stimulus points in the same direction as the "flankers" (congruent) and sometimes in the opposite direction (incongruent) over 20 trials.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
The Flanker Inhibitory Control and Attention Test 3 months	93.2 score on a scale Standard Deviation 16.0
The Flanker Inhibitory Control and Attention Test Baseline	87.9 score on a scale Standard Deviation 14.5
The Flanker Inhibitory Control and Attention Test 6 months	92.6 score on a scale Standard Deviation 17.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 months, 6 months

The Dimensional Change Card Sort Test is a measure of cognitive flexibility and attention. Two target pictures are presented that vary along two dimensions (e.g., shape and color). Participants are asked to match a series of bivalent test pictures (e.g., yellow balls and blue trucks) to the target pictures, first according to one dimension (e.g., color) and then, after a number of trials, according to the other dimension (e.g., shape). The relevant dimension for sorting is indicated by a cue word (e.g., "shape" or "color") that appears on the screen for all participants. Age-adjusted scores are calculated automatically by the NIH Toolbox software. Higher scores indicate better function.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
The Dimensional Change Card Sort Test Baseline	101 score on a scale Standard Deviation 19.7
The Dimensional Change Card Sort Test 3 months	100.7 score on a scale Standard Deviation 10.0
The Dimensional Change Card Sort Test 6 months	100.6 score on a scale Standard Deviation 20.1

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

The Oral Symbol digit test is a measure of working memory and processing speed. A key with nine abstract symbols is presented - each paired with a number between 1 and 9. Participants are asked to verbally indicate which numbers go with the symbols that are presented in a long string on the computer screen. The participant is given 120 seconds to call out as many numbers that go with the corresponding symbols as he/she can - in order, without skipping any. Age-adjusted scores were calculated automatically by the NIH Toolbox software. Higher scores indicate better function.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Oral Symbol Digit Test Baseline	58.8 score on a scale Standard Deviation 18.0
Oral Symbol Digit Test 3 months	65.7 score on a scale Standard Deviation 22.0
Oral Symbol Digit Test 6 months	62.8 score on a scale Standard Deviation 23.5

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

The Picture Sequence Memory Test is a measure of episodic memory. Sequences of pictured objects and activities are presented in a particular order. The participants are asked to reproduce the sequence of pictures that is shown on the screen. Participants respond by dragging pictures from the yellow box on the screen into the gray boxes on the screen.

Age-adjusted scores were calculated automatically by the NIH Toolbox software. Higher scores indicate better function.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Picture Sequence Memory Test Baseline	98.2 score on a scale Standard Deviation 15.2
Picture Sequence Memory Test 3 months	102.1 score on a scale Standard Deviation 18.8
Picture Sequence Memory Test 6 months	109.9 score on a scale Standard Deviation 20.0

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

The List Sorting Working Memory Test is a measure of working memory. Pictures of foods and animals are displayed with accompanying audio recording and written text (e.g., "elephant"), and the participant is asked to say the items back in size order from smallest to largest, first within a single dimension (either animals or foods) and then on two dimensions (foods, then animals). Age-adjusted scores were calculated automatically by the NIH Toolbox software. Higher scores indicate better function.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
List Sorting Working Memory Test Baseline	98.2 score on a scale Standard Deviation 13.7
List Sorting Working Memory Test 3 months	101.5 score on a scale Standard Deviation 14.9
List Sorting Working Memory Test 6 months	100.3 score on a scale Standard Deviation 62.8

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

Hospital Anxiety and Depression Scale depression scores. Score range 0-21. Higher scores indicate greater psychological morbidity.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Depressive Symptoms 3 months	4.3 score on a scale Standard Deviation 3.2
Depressive Symptoms 6 months	4.9 score on a scale Standard Deviation 3.6
Depressive Symptoms Baseline	3.6 score on a scale Standard Deviation 3.3

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

Pittsburgh Sleep Quality Index. Self-report measure of sleep quality and quantity. Higher scores indicate better sleep quality and quantity. The overall score range is 0-21.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Sleep Quality baseline	7.2 score on a scale Standard Deviation 3.9
Sleep Quality 3 months	6.9 score on a scale Standard Deviation 3.9
Sleep Quality 6 months	7.6 score on a scale Standard Deviation 4.6

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales.

The theoretical range for the noticing subscale score was 0-20.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Interoceptive Awareness: Noticing Score baseline	12.7 score on a scale Standard Deviation 4.0
Interoceptive Awareness: Noticing Score 3 months	14.5 score on a scale Standard Deviation 4.1
Interoceptive Awareness: Noticing Score 6 months	15.0 score on a scale Standard Deviation 4.0

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales.

The theoretical range for the not distracting subscale score was 0-15.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Interoceptive Awareness: Not Distracting Score 6 months	7.3 score on a scale Standard Deviation 4.0
Interoceptive Awareness: Not Distracting Score baseline	6.6 score on a scale Standard Deviation 3.2
Interoceptive Awareness: Not Distracting Score 3 months	7.2 score on a scale Standard Deviation 3.3

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales.

The theoretical range for the not-worrying subscale was 0-15.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Interoceptive Awareness: Not Worrying Score baseline	8.2 score on a scale Standard Deviation 2.1
Interoceptive Awareness: Not Worrying Score 6 months	7.8 score on a scale Standard Deviation 2.7
Interoceptive Awareness: Not Worrying Score 3 months	8.3 score on a scale Standard Deviation 2.4

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales.

The theoretical range for the attention regulation subscale score was 0-35.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Interoceptive Awareness: Attention Regulation Score baseline	20.1 score on a scale Standard Deviation 7.9
Interoceptive Awareness: Attention Regulation Score 3 months	24.2 score on a scale Standard Deviation 6.5
Interoceptive Awareness: Attention Regulation Score 6 months	23.5 score on a scale Standard Deviation 5.6

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales.

The theoretical range for the emotional awareness score was 0-25.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Interoceptive Awareness: Emotional Awareness Score 3 months	18.3 score on a scale Standard Deviation 5.3
Interoceptive Awareness: Emotional Awareness Score baseline	15.9 score on a scale Standard Deviation 5.2
Interoceptive Awareness: Emotional Awareness Score 6 months	17.9 score on a scale Standard Deviation 5.3

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales.

The theoretical range for the self-regulation score was 0-20.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Interoceptive Awareness: Self-regulation Score baseline	11.7 score on a scale Standard Deviation 5.0
Interoceptive Awareness: Self-regulation Score 3 months	14.7 score on a scale Standard Deviation 3.6
Interoceptive Awareness: Self-regulation Score 6 months	14.5 score on a scale Standard Deviation 3.9

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales.

The theoretical range for the body listening score was 0-15.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Interoceptive Awareness: Body Listening Score 3 months	8.9 score on a scale Standard Deviation 3.4
Interoceptive Awareness: Body Listening Score baseline	7.4 score on a scale Standard Deviation 4.2
Interoceptive Awareness: Body Listening Score 6 months	9.6 score on a scale Standard Deviation 4.0

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 3 months, 6 months

The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales.

The theoretical range for the trusting subscale score was 0-15.

Outcome measures

Measure	Mindfulness Training (MT) n=31 Participants Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Interoceptive Awareness: Trusting Score baseline	9.8 score on a scale Standard Deviation 3.9
Interoceptive Awareness: Trusting Score 6 months	11.3 score on a scale Standard Deviation 3.5
Interoceptive Awareness: Trusting Score 3 months	11.1 score on a scale Standard Deviation 2.8

Adverse Events

Mindfulness Training (MT)

Serious events: 3 serious events

Other events: 8 other events

Deaths: 2 deaths

Serious adverse events

Measure	Mindfulness Training (MT) n=31 participants at risk Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 20 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Cardiac disorders sudden cardiac death	3.2% 1/31 • Number of events 1 • 6 months
Cardiac disorders death	3.2% 1/31 • Number of events 1 • 6 months
Nervous system disorders stroke	3.2% 1/31 • Number of events 1 • 6 months

Other adverse events

Measure	Mindfulness Training (MT) n=31 participants at risk Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 20 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
Infections and infestations influenza	3.2% 1/31 • Number of events 1 • 6 months
Cardiac disorders uncontrolled hypertension	3.2% 1/31 • Number of events 1 • 6 months
Musculoskeletal and connective tissue disorders fall	3.2% 1/31 • Number of events 1 • 6 months
Musculoskeletal and connective tissue disorders Chest pain	3.2% 1/31 • Number of events 1 • 6 months
Surgical and medical procedures Impacted tooth	3.2% 1/31 • Number of events 1 • 6 months
Infections and infestations pneumonia	3.2% 1/31 • Number of events 1 • 6 months
Social circumstances car accident	3.2% 1/31 • Number of events 1 • 6 months
Surgical and medical procedures elective surgery	3.2% 1/31 • Number of events 1 • 6 months

Additional Information

Elena Salmoirago-Blotcher

The Miriam Hospital

Phone: 401-793-8325

Email: Elena_Salmoirago_Blotcher@brown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place