Medication Non-adherence
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate | 3 months, 6 months | Percentage of participants retained in the study (n enrolled/n retained X 100) |
| Intervention Acceptability | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Medication Adherence | baseline, 3 months, 6 months | The Voils extent of non-adherence scale ranges from 1-5. Higher scores represent greater non-adherence. |
| Objectively-assessed Medication Adherence | 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. |
| Functional Capacity | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | baseline, 3 months, 6 months | Hospital Anxiety and Depression Scale depression scores. Score range 0-21. Higher scores indicate greater psychological morbidity. |
| Sleep Quality | 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. |
| Interoceptive Awareness: Noticing Score | 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. |
| Interoceptive Awareness: Not Distracting Score | 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. |
| Interoceptive Awareness: Not Worrying Score | 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. |
| The Flanker Inhibitory Control and Attention Test | 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. |
| Interoceptive Awareness: Emotional Awareness Score | 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. |
| Interoceptive Awareness: Self-regulation Score | 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. |
| Interoceptive Awareness: Body Listening Score | 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. |
| Interoceptive Awareness: Trusting Score | 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. |
| Interoceptive Awareness: Attention Regulation Score | 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. |
| The Dimensional Change Card Sort Test | 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. |
| Oral Symbol Digit Test | 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. |
| Picture Sequence Memory Test | 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. |
| List Sorting Working Memory Test | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Mindfulness Training (MT) |
|---|---|
| Age, Continuous | 60.3 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 type | EG000 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
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness Training (MT) | Intervention Acceptability | 24 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mindfulness Training (MT) | Retention Rate | 3 months | 31 Participants |
| Mindfulness Training (MT) | Retention Rate | 6 months | 29 Participants |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Functional Capacity | baseline | 350 meters | Standard Deviation 93 |
| Mindfulness Training (MT) | Functional Capacity | 3 months | 378 meters | Standard Deviation 97 |
| Mindfulness Training (MT) | Functional Capacity | 6 months | 374 meters | Standard Deviation 95 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Objectively-assessed Medication Adherence | Baseline | 73 percentage of meds taken/prescrib | Standard Deviation 28 |
| Mindfulness Training (MT) | Objectively-assessed Medication Adherence | 3 months | 58 percentage of meds taken/prescrib | Standard Deviation 35 |
| Mindfulness Training (MT) | Objectively-assessed Medication Adherence | 6 months | 61 percentage of meds taken/prescrib | Standard Deviation 37 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Self-reported Medication Adherence | Baseline | 2.8 score on a scale | Standard Deviation 2.6 |
| Mindfulness Training (MT) | Self-reported Medication Adherence | 3 months | 2.6 score on a scale | Standard Deviation 0.6 |
| Mindfulness Training (MT) | Self-reported Medication Adherence | 6 months | 2.6 score on a scale | Standard Deviation 0.3 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Depressive Symptoms | Baseline | 3.6 score on a scale | Standard Deviation 3.3 |
| Mindfulness Training (MT) | Depressive Symptoms | 3 months | 4.3 score on a scale | Standard Deviation 3.2 |
| Mindfulness Training (MT) | Depressive Symptoms | 6 months | 4.9 score on a scale | Standard Deviation 3.6 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Interoceptive Awareness: Attention Regulation Score | baseline | 20.1 score on a scale | Standard Deviation 7.9 |
| Mindfulness Training (MT) | Interoceptive Awareness: Attention Regulation Score | 3 months | 24.2 score on a scale | Standard Deviation 6.5 |
| Mindfulness Training (MT) | Interoceptive Awareness: Attention Regulation Score | 6 months | 23.5 score on a scale | Standard Deviation 5.6 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Interoceptive Awareness: Body Listening Score | baseline | 7.4 score on a scale | Standard Deviation 4.2 |
| Mindfulness Training (MT) | Interoceptive Awareness: Body Listening Score | 3 months | 8.9 score on a scale | Standard Deviation 3.4 |
| Mindfulness Training (MT) | Interoceptive Awareness: Body Listening Score | 6 months | 9.6 score on a scale | Standard Deviation 4 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Interoceptive Awareness: Emotional Awareness Score | baseline | 15.9 score on a scale | Standard Deviation 5.2 |
| Mindfulness Training (MT) | Interoceptive Awareness: Emotional Awareness Score | 3 months | 18.3 score on a scale | Standard Deviation 5.3 |
| Mindfulness Training (MT) | Interoceptive Awareness: Emotional Awareness Score | 6 months | 17.9 score on a scale | Standard Deviation 5.3 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Interoceptive Awareness: Not Distracting Score | baseline | 6.6 score on a scale | Standard Deviation 3.2 |
| Mindfulness Training (MT) | Interoceptive Awareness: Not Distracting Score | 3 months | 7.2 score on a scale | Standard Deviation 3.3 |
| Mindfulness Training (MT) | Interoceptive Awareness: Not Distracting Score | 6 months | 7.3 score on a scale | Standard Deviation 4 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Interoceptive Awareness: Noticing Score | baseline | 12.7 score on a scale | Standard Deviation 4 |
| Mindfulness Training (MT) | Interoceptive Awareness: Noticing Score | 3 months | 14.5 score on a scale | Standard Deviation 4.1 |
| Mindfulness Training (MT) | Interoceptive Awareness: Noticing Score | 6 months | 15.0 score on a scale | Standard Deviation 4 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Interoceptive Awareness: Not Worrying Score | baseline | 8.2 score on a scale | Standard Deviation 2.1 |
| Mindfulness Training (MT) | Interoceptive Awareness: Not Worrying Score | 3 months | 8.3 score on a scale | Standard Deviation 2.4 |
| Mindfulness Training (MT) | Interoceptive Awareness: Not Worrying Score | 6 months | 7.8 score on a scale | Standard Deviation 2.7 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Interoceptive Awareness: Self-regulation Score | 3 months | 14.7 score on a scale | Standard Deviation 3.6 |
| Mindfulness Training (MT) | Interoceptive Awareness: Self-regulation Score | 6 months | 14.5 score on a scale | Standard Deviation 3.9 |
| Mindfulness Training (MT) | Interoceptive Awareness: Self-regulation Score | baseline | 11.7 score on a scale | Standard Deviation 5 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Interoceptive Awareness: Trusting Score | baseline | 9.8 score on a scale | Standard Deviation 3.9 |
| Mindfulness Training (MT) | Interoceptive Awareness: Trusting Score | 3 months | 11.1 score on a scale | Standard Deviation 2.8 |
| Mindfulness Training (MT) | Interoceptive Awareness: Trusting Score | 6 months | 11.3 score on a scale | Standard Deviation 3.5 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | List Sorting Working Memory Test | Baseline | 98.2 score on a scale | Standard Deviation 13.7 |
| Mindfulness Training (MT) | List Sorting Working Memory Test | 3 months | 101.5 score on a scale | Standard Deviation 14.9 |
| Mindfulness Training (MT) | List Sorting Working Memory Test | 6 months | 100.3 score on a scale | Standard Deviation 62.8 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Oral Symbol Digit Test | Baseline | 58.8 score on a scale | Standard Deviation 18 |
| Mindfulness Training (MT) | Oral Symbol Digit Test | 3 months | 65.7 score on a scale | Standard Deviation 22 |
| Mindfulness Training (MT) | Oral Symbol Digit Test | 6 months | 62.8 score on a scale | Standard Deviation 23.5 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Picture Sequence Memory Test | 6 months | 109.9 score on a scale | Standard Deviation 20 |
| Mindfulness Training (MT) | Picture Sequence Memory Test | Baseline | 98.2 score on a scale | Standard Deviation 15.2 |
| Mindfulness Training (MT) | Picture Sequence Memory Test | 3 months | 102.1 score on a scale | Standard Deviation 18.8 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | Sleep Quality | baseline | 7.2 score on a scale | Standard Deviation 3.9 |
| Mindfulness Training (MT) | Sleep Quality | 3 months | 6.9 score on a scale | Standard Deviation 3.9 |
| Mindfulness Training (MT) | Sleep Quality | 6 months | 7.6 score on a scale | Standard Deviation 4.6 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | The Dimensional Change Card Sort Test | Baseline | 101 score on a scale | Standard Deviation 19.7 |
| Mindfulness Training (MT) | The Dimensional Change Card Sort Test | 3 months | 100.7 score on a scale | Standard Deviation 10 |
| Mindfulness Training (MT) | The Dimensional Change Card Sort Test | 6 months | 100.6 score on a scale | Standard Deviation 20.1 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training (MT) | The Flanker Inhibitory Control and Attention Test | Baseline | 87.9 score on a scale | Standard Deviation 14.5 |
| Mindfulness Training (MT) | The Flanker Inhibitory Control and Attention Test | 3 months | 93.2 score on a scale | Standard Deviation 16 |
| Mindfulness Training (MT) | The Flanker Inhibitory Control and Attention Test | 6 months | 92.6 score on a scale | Standard Deviation 17.6 |