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Mind Your Heart Study

Exploring the Role of Mindfulness Training in the Promotion of Medication Adherence in Heart Failure Outpatients.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03571581
Enrollment
33
Registered
2018-06-27
Start date
2018-10-11
Completion date
2020-08-31
Last updated
2025-07-14

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

Conditions

Medication Non-adherence

Keywords

Medication adherence, Heart failure, Mindfulness interventions

Brief summary

This study investigated the feasibility and acceptability of a phone-delivered mindfulness intervention to improve medication adherence among outpatients with heart failure.

Detailed description

This project seeked to study the role of mindfulness training (MT) in the promotion of medication adherence among patients with chronic heart failure (HF). A prospective pre/post design study was conducted among 50 stable outpatients with HF and sub-optimal self-reported medication adherence. MT sessions (one 30-min session/week over 8 weeks) were phone-delivered by qualified mindfulness instructors. Assessments were conducted at baseline, 3 months (end of the intervention) and 6 months since baseline. The primary outcomes were feasibility and acceptability. We hypothesized we would meet recruitment goals (n=50) within the study timeline, with \< 20% drop out rates by the end of the study and that \> 80% of participants would report high (=grade 5) enjoyment ratings on a self-report intervention enjoyment scale (range:1 to 5). Secondary outcomes were self-reported and objectively assessed medication adherence and functional capacity (a clinical marker of medication adherence. We hypothesized we would observe significant pre-post intervention improvements in medication adherence and functional capacity. Additional outcomes included possible mediators of intervention effect, i.e., cognitive function, mood, sleep quality, and interoceptive awareness.

Interventions

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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
The Miriam 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 * Fluency in English language * A confirmed diagnosis of heart failure * Sub-optimal adherence to medications * Access to a telephone * Ability to understand and speak English

Exclusion criteria

* Unwillingness/inability to provide informed consent * New York Heart Association (NYHA) class IV heart failure or clinically unstable * Severe hearing impairment not allowing phone delivery * Severe depressive symptoms * Acute psychosis * Severe cognitive impairment * Recent hospitalization (\< 6 weeks) * Current (at least once a month) mind/body practice

Design outcomes

Primary

MeasureTime frameDescription
Retention Rate3 months, 6 monthsPercentage of participants retained in the study (n enrolled/n retained X 100)
Intervention Acceptability3 monthsSelf-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).

Secondary

MeasureTime frameDescription
Self-reported Medication Adherencebaseline, 3 months, 6 monthsThe Voils extent of non-adherence scale ranges from 1-5. Higher scores represent greater non-adherence.
Objectively-assessed Medication Adherencebaseline, 3 months, 6 monthsMedication 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.
Functional Capacitybaseline, 3 months, 6 months6-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.

Other

MeasureTime frameDescription
Depressive Symptomsbaseline, 3 months, 6 monthsHospital Anxiety and Depression Scale depression scores. Score range 0-21. Higher scores indicate greater psychological morbidity.
Sleep Qualitybaseline, 3 months, 6 monthsPittsburgh 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.
Interoceptive Awareness: Noticing Scorebaseline, 3 months, 6 monthsThe 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.
Interoceptive Awareness: Not Distracting Scorebaseline, 3 months, 6 monthsThe 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.
Interoceptive Awareness: Not Worrying Scorebaseline, 3 months, 6 monthsThe 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.
The Flanker Inhibitory Control and Attention Testbaseline, 3 months, 6 monthsCognitive 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.
Interoceptive Awareness: Emotional Awareness Scorebaseline, 3 months, 6 monthsThe 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.
Interoceptive Awareness: Self-regulation Scorebaseline, 3 months, 6 monthsThe 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.
Interoceptive Awareness: Body Listening Scorebaseline, 3 months, 6 monthsThe 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.
Interoceptive Awareness: Trusting Scorebaseline, 3 months, 6 monthsThe 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.
Interoceptive Awareness: Attention Regulation Scorebaseline, 3 months, 6 monthsThe 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.
The Dimensional Change Card Sort TestBaseline, 3 months, 6 monthsThe 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.
Oral Symbol Digit Testbaseline, 3 months, 6 monthsThe 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.
Picture Sequence Memory Testbaseline, 3 months, 6 monthsThe 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.
List Sorting Working Memory Testbaseline, 3 months, 6 monthsThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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 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.
33
Total33

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDeath2
Overall StudyWithdrawal by Subject2

Baseline characteristics

CharacteristicMindfulness Training (MT)
Age, Continuous60.3 Years
STANDARD_DEVIATION 10.7
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
Race (NIH/OMB)
White
23 Participants
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
23 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
2 / 31
other
Total, other adverse events
8 / 31
serious
Total, serious adverse events
3 / 31

Outcome results

Primary

Intervention Acceptability

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).

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mindfulness Training (MT)Intervention Acceptability24 Participants
Primary

Retention Rate

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

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Mindfulness Training (MT)Retention Rate3 months31 Participants
Mindfulness Training (MT)Retention Rate6 months29 Participants
Secondary

Functional Capacity

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.

Time frame: baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)Functional Capacitybaseline350 metersStandard Deviation 93
Mindfulness Training (MT)Functional Capacity3 months378 metersStandard Deviation 97
Mindfulness Training (MT)Functional Capacity6 months374 metersStandard Deviation 95
Secondary

Objectively-assessed Medication Adherence

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.

Time frame: baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)Objectively-assessed Medication AdherenceBaseline73 percentage of meds taken/prescribStandard Deviation 28
Mindfulness Training (MT)Objectively-assessed Medication Adherence3 months58 percentage of meds taken/prescribStandard Deviation 35
Mindfulness Training (MT)Objectively-assessed Medication Adherence6 months61 percentage of meds taken/prescribStandard Deviation 37
Secondary

Self-reported Medication Adherence

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

Time frame: baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)Self-reported Medication AdherenceBaseline2.8 score on a scaleStandard Deviation 2.6
Mindfulness Training (MT)Self-reported Medication Adherence3 months2.6 score on a scaleStandard Deviation 0.6
Mindfulness Training (MT)Self-reported Medication Adherence6 months2.6 score on a scaleStandard Deviation 0.3
Other Pre-specified

Depressive Symptoms

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

Time frame: baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)Depressive SymptomsBaseline3.6 score on a scaleStandard Deviation 3.3
Mindfulness Training (MT)Depressive Symptoms3 months4.3 score on a scaleStandard Deviation 3.2
Mindfulness Training (MT)Depressive Symptoms6 months4.9 score on a scaleStandard Deviation 3.6
Other Pre-specified

Interoceptive Awareness: Attention Regulation Score

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.

Time frame: baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)Interoceptive Awareness: Attention Regulation Scorebaseline20.1 score on a scaleStandard Deviation 7.9
Mindfulness Training (MT)Interoceptive Awareness: Attention Regulation Score3 months24.2 score on a scaleStandard Deviation 6.5
Mindfulness Training (MT)Interoceptive Awareness: Attention Regulation Score6 months23.5 score on a scaleStandard Deviation 5.6
Other Pre-specified

Interoceptive Awareness: Body Listening Score

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.

Time frame: baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)Interoceptive Awareness: Body Listening Scorebaseline7.4 score on a scaleStandard Deviation 4.2
Mindfulness Training (MT)Interoceptive Awareness: Body Listening Score3 months8.9 score on a scaleStandard Deviation 3.4
Mindfulness Training (MT)Interoceptive Awareness: Body Listening Score6 months9.6 score on a scaleStandard Deviation 4
Other Pre-specified

Interoceptive Awareness: Emotional Awareness Score

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.

Time frame: baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)Interoceptive Awareness: Emotional Awareness Scorebaseline15.9 score on a scaleStandard Deviation 5.2
Mindfulness Training (MT)Interoceptive Awareness: Emotional Awareness Score3 months18.3 score on a scaleStandard Deviation 5.3
Mindfulness Training (MT)Interoceptive Awareness: Emotional Awareness Score6 months17.9 score on a scaleStandard Deviation 5.3
Other Pre-specified

Interoceptive Awareness: Not Distracting Score

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.

Time frame: baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)Interoceptive Awareness: Not Distracting Scorebaseline6.6 score on a scaleStandard Deviation 3.2
Mindfulness Training (MT)Interoceptive Awareness: Not Distracting Score3 months7.2 score on a scaleStandard Deviation 3.3
Mindfulness Training (MT)Interoceptive Awareness: Not Distracting Score6 months7.3 score on a scaleStandard Deviation 4
Other Pre-specified

Interoceptive Awareness: Noticing Score

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.

Time frame: baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)Interoceptive Awareness: Noticing Scorebaseline12.7 score on a scaleStandard Deviation 4
Mindfulness Training (MT)Interoceptive Awareness: Noticing Score3 months14.5 score on a scaleStandard Deviation 4.1
Mindfulness Training (MT)Interoceptive Awareness: Noticing Score6 months15.0 score on a scaleStandard Deviation 4
Other Pre-specified

Interoceptive Awareness: Not Worrying Score

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.

Time frame: baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)Interoceptive Awareness: Not Worrying Scorebaseline8.2 score on a scaleStandard Deviation 2.1
Mindfulness Training (MT)Interoceptive Awareness: Not Worrying Score3 months8.3 score on a scaleStandard Deviation 2.4
Mindfulness Training (MT)Interoceptive Awareness: Not Worrying Score6 months7.8 score on a scaleStandard Deviation 2.7
Other Pre-specified

Interoceptive Awareness: Self-regulation Score

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.

Time frame: baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)Interoceptive Awareness: Self-regulation Score3 months14.7 score on a scaleStandard Deviation 3.6
Mindfulness Training (MT)Interoceptive Awareness: Self-regulation Score6 months14.5 score on a scaleStandard Deviation 3.9
Mindfulness Training (MT)Interoceptive Awareness: Self-regulation Scorebaseline11.7 score on a scaleStandard Deviation 5
Other Pre-specified

Interoceptive Awareness: Trusting Score

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.

Time frame: baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)Interoceptive Awareness: Trusting Scorebaseline9.8 score on a scaleStandard Deviation 3.9
Mindfulness Training (MT)Interoceptive Awareness: Trusting Score3 months11.1 score on a scaleStandard Deviation 2.8
Mindfulness Training (MT)Interoceptive Awareness: Trusting Score6 months11.3 score on a scaleStandard Deviation 3.5
Other Pre-specified

List Sorting Working Memory Test

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.

Time frame: baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)List Sorting Working Memory TestBaseline98.2 score on a scaleStandard Deviation 13.7
Mindfulness Training (MT)List Sorting Working Memory Test3 months101.5 score on a scaleStandard Deviation 14.9
Mindfulness Training (MT)List Sorting Working Memory Test6 months100.3 score on a scaleStandard Deviation 62.8
Other Pre-specified

Oral Symbol Digit Test

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.

Time frame: baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)Oral Symbol Digit TestBaseline58.8 score on a scaleStandard Deviation 18
Mindfulness Training (MT)Oral Symbol Digit Test3 months65.7 score on a scaleStandard Deviation 22
Mindfulness Training (MT)Oral Symbol Digit Test6 months62.8 score on a scaleStandard Deviation 23.5
Other Pre-specified

Picture Sequence Memory Test

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.

Time frame: baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)Picture Sequence Memory Test6 months109.9 score on a scaleStandard Deviation 20
Mindfulness Training (MT)Picture Sequence Memory TestBaseline98.2 score on a scaleStandard Deviation 15.2
Mindfulness Training (MT)Picture Sequence Memory Test3 months102.1 score on a scaleStandard Deviation 18.8
Other Pre-specified

Sleep Quality

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.

Time frame: baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)Sleep Qualitybaseline7.2 score on a scaleStandard Deviation 3.9
Mindfulness Training (MT)Sleep Quality3 months6.9 score on a scaleStandard Deviation 3.9
Mindfulness Training (MT)Sleep Quality6 months7.6 score on a scaleStandard Deviation 4.6
Other Pre-specified

The Dimensional Change Card Sort Test

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.

Time frame: Baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)The Dimensional Change Card Sort TestBaseline101 score on a scaleStandard Deviation 19.7
Mindfulness Training (MT)The Dimensional Change Card Sort Test3 months100.7 score on a scaleStandard Deviation 10
Mindfulness Training (MT)The Dimensional Change Card Sort Test6 months100.6 score on a scaleStandard Deviation 20.1
Other Pre-specified

The Flanker Inhibitory Control and Attention Test

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.

Time frame: baseline, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Mindfulness Training (MT)The Flanker Inhibitory Control and Attention TestBaseline87.9 score on a scaleStandard Deviation 14.5
Mindfulness Training (MT)The Flanker Inhibitory Control and Attention Test3 months93.2 score on a scaleStandard Deviation 16
Mindfulness Training (MT)The Flanker Inhibitory Control and Attention Test6 months92.6 score on a scaleStandard Deviation 17.6

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026