Trial Outcomes & Findings for Healthy Minds Program App Dosage (NCT NCT05229406)

Results Overview

Percentage of those randomized completing ecological momentary assessment (EMA) assessments and activities in the Healthy Minds Program (HMP) app

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

92 participants

Primary outcome timeframe

Baseline to post-test (week 4)

Results posted on

2023-08-01

Participant Flow

Participants were enrolled from February 2022 to June 2022.

Participant milestones

Participant milestones
Measure	5-minute App Usage Participants will be asked to use the HMP app for 5-minutes per day. HMP app: The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage Participants will be asked to use the HMP app for 15-minutes per day. HMP app: The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Overall Study STARTED	46	46
Overall Study COMPLETED	45	44
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	5-minute App Usage Participants will be asked to use the HMP app for 5-minutes per day. HMP app: The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage Participants will be asked to use the HMP app for 15-minutes per day. HMP app: The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Healthy Minds Program App Dosage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	Total n=92 Participants Total of all reporting groups
Age, Continuous	30.72 years STANDARD_DEVIATION 11.48 • n=5 Participants	31.85 years STANDARD_DEVIATION 14.68 • n=7 Participants	31.28 years STANDARD_DEVIATION 13.12 • n=5 Participants
Sex/Gender, Customized Female	41 Participants n=5 Participants	34 Participants n=7 Participants	75 Participants n=5 Participants
Sex/Gender, Customized Male	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Sex/Gender, Customized Other Gender	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic White	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized American Indian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Multiracial	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	29 Participants n=5 Participants	27 Participants n=7 Participants	56 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	46 participants n=7 Participants	92 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to post-test (week 4)

Percentage of those randomized completing ecological momentary assessment (EMA) assessments and activities in the Healthy Minds Program (HMP) app

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Randomization Rate: Number of Participants Who Were Randomized and Completed EMA Assessments and Activities in the HMP App	46 Participants	46 Participants

PRIMARY outcome

Timeframe: Baseline to post-test (week 4)

Number of participants adhering to their assigned dosage greater than or equal to 50 percent of the days. This was assessed directly through the HMP app.

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Dosage Adherence: Number of Participants Adhering to Their Dosage Greater Than or Equal to 50 Percent of the Days	22 Participants	16 Participants

PRIMARY outcome

Timeframe: Baseline to post-test (week 4)

Percentage of EMA assessments that were completed

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Percentage of EMA Completed	82.71 percentage of EMA assessments complete Standard Deviation 32.82	78.61 percentage of EMA assessments complete Standard Deviation 41.00

PRIMARY outcome

Timeframe: Baseline to post-test (week 4)

Percentage of participants completing pre- and post-test measures

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Study Completion Rate	45 Participants	44 Participants

PRIMARY outcome

Timeframe: Baseline to post-test (week 4)

Number of participants completing practices ≥50% of days

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Number of Participants Completing Practices ≥50% of Days	32 Participants	26 Participants

PRIMARY outcome

Timeframe: Post-test (week 4)

Population: 3 participants withdrew from the study

The MSUS is a 10-item questionnaire where participants report their experience of the usability of a product, in this case the HMP app. It is scored on a 1- to 5-point Likert scale where 1 = strongly disagree and 5 = strongly agree. The result was rescaled to range from 0 to 100 with higher scores indicate higher usability.

Outcome measures

Outcome measures
Measure	5-minute App Usage n=45 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=44 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Modified System Usability Scale (MSUS)	84.56 score on a scale Standard Deviation 10.86	83.66 score on a scale Standard Deviation 14.21

PRIMARY outcome

Timeframe: Baseline, and post-test (week 4)

Population: 3 participants withdrew from the study

The ATPOI is a 16-item questionnaire where participants report their perception of psychological online interventions. It is scored on a 1- to 5-point Likert scale where 1 = totally disagree and 5 = totally agree. Mean scores are reported for a total possible range of scores is 1 to 5 where higher scores indicate more positive attitudes towards psychological online interventions.

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Change in Attitudes Towards Psychological Online Interventions (ATPOI) T1 Baseline	3.30 score on a scale Standard Deviation 0.39	3.20 score on a scale Standard Deviation 0.36
Change in Attitudes Towards Psychological Online Interventions (ATPOI) T2 Post-Test Week 4	3.45 score on a scale Standard Deviation 0.50	3.47 score on a scale Standard Deviation 0.64
Change in Attitudes Towards Psychological Online Interventions (ATPOI) Change	0.15 score on a scale Standard Deviation 0.47	0.27 score on a scale Standard Deviation 0.44

PRIMARY outcome

Timeframe: Baseline to post-test (week 4)

Minutes of meditation practice completed

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
HMP App Utilization: Minutes	100.85 minutes Standard Deviation 66.13	201.76 minutes Standard Deviation 144.61

PRIMARY outcome

Timeframe: Baseline to post-test (week 4)

Number of days the app was accessed.

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
HMP App Utilization: Days	17.28 days Standard Deviation 7.00	14.72 days Standard Deviation 7.89

PRIMARY outcome

Timeframe: Baseline to post-test (week 4)

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
HMP App Utilization: Number of Activities	57.65 activities Standard Deviation 32.40	51.43 activities Standard Deviation 44.91

SECONDARY outcome

Timeframe: Baseline, and post-test (week 4)

Population: 3 participants withdrew from the study

Psychological distress will be computed as a composite of the PROMIS Depression and PROMIS Anxiety measures. We will use the computer adaptive version of both measures which have a mean of 50 and a standard deviation of 10. A composite will be computed by average across T-scores. T-scores range from 10 to 90 with higher scores indicating higher depression or anxiety.

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety T1 baseline	60.93 T-score Standard Deviation 5.38	61.08 T-score Standard Deviation 5.24
Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety T2 post-test (week 4)	57.28 T-score Standard Deviation 5.63	56.78 T-score Standard Deviation 6.02
Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety Change	-3.58 T-score Standard Deviation 4.32	-4.44 T-score Standard Deviation 7.07

SECONDARY outcome

Timeframe: Baseline, and post-test (week 4)

Population: 3 participants withdrew from the study

The HM Index assesses qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. There are 4 awareness items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more awareness.

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Change in Healthy Minds Index (HM Index): Awareness T1 Baseline	3.29 score on a scale Standard Deviation 0.53	3.26 score on a scale Standard Deviation 0.67
Change in Healthy Minds Index (HM Index): Awareness T2 Post-Test Week 4	3.42 score on a scale Standard Deviation 0.66	3.40 score on a scale Standard Deviation 0.70
Change in Healthy Minds Index (HM Index): Awareness Change	0.13 score on a scale Standard Deviation 0.65	0.12 score on a scale Standard Deviation 0.77

SECONDARY outcome

Timeframe: Baseline, and post-test (week 4)

Population: 3 participants withdrew from the study

The HM Index assesses qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. There are 6 connection items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more connection.

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Change in Healthy Minds Index (HM Index): Connection T1 Baseline	3.56 score on a scale Standard Deviation 0.58	3.55 score on a scale Standard Deviation 0.55
Change in Healthy Minds Index (HM Index): Connection T2 Post-Test Week 4	3.72 score on a scale Standard Deviation 0.71	3.87 score on a scale Standard Deviation 0.44
Change in Healthy Minds Index (HM Index): Connection Change	0.16 score on a scale Standard Deviation 0.48	0.34 score on a scale Standard Deviation 0.48

SECONDARY outcome

Timeframe: Baseline, and post-test (week 4)

Population: 3 participants withdrew from the study

The HM Index assesses qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. There are 3 insight items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more insight.

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Change in Healthy Minds Index (HM Index): Insight T2 Post-Test Week 4	3.11 score on a scale Standard Deviation 0.76	3.33 score on a scale Standard Deviation 0.65
Change in Healthy Minds Index (HM Index): Insight T1 Baseline	2.86 score on a scale Standard Deviation 0.68	2.77 score on a scale Standard Deviation 0.60
Change in Healthy Minds Index (HM Index): Insight Change	0.27 score on a scale Standard Deviation 0.76	0.56 score on a scale Standard Deviation 0.80

SECONDARY outcome

Timeframe: Baseline, and post-test (week 4)

Population: 3 participants withdrew from the study

The HM Index assesses qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. There are 4 purpose items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more purpose.

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Change in Healthy Minds Index (HM Index): Purpose T1 Baseline	3.43 score on a scale Standard Deviation 0.85	3.49 score on a scale Standard Deviation 0.83
Change in Healthy Minds Index (HM Index): Purpose T2 Post-Test Week 4	3.80 score on a scale Standard Deviation 0.79	3.88 score on a scale Standard Deviation 0.90
Change in Healthy Minds Index (HM Index): Purpose Change	0.38 score on a scale Standard Deviation 0.90	0.40 score on a scale Standard Deviation 0.94

SECONDARY outcome

Timeframe: Baseline, and post-test (week 4)

Population: 3 participants withdrew from the study

Well-being Growth Mindset is a 3-item questionnaire assessing participants' perception of the malleability of wellbeing. It is scored on a 1- to 6-point Likert scale where 1 = strongly disagree and 6 = strongly agree. Total scores range from 3 to 18 where higher scores indicate more of a growth mindset (i.e., wellbeing is malleable).

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Change in Wellbeing Growth Mindset T1 Baseline	13.77 score on a scale Standard Deviation 3.02	13.48 score on a scale Standard Deviation 2.99
Change in Wellbeing Growth Mindset T2 Post-time Week 4	14.60 score on a scale Standard Deviation 2.64	15.11 score on a scale Standard Deviation 2.63
Change in Wellbeing Growth Mindset Change	0.68 score on a scale Standard Deviation 2.15	1.59 score on a scale Standard Deviation 2.38

SECONDARY outcome

Timeframe: Baseline, and post-test (week 4)

Population: 3 participants withdrew from the study

FFMQ Awareness is a 8-item questionnaire assessing mindful awareness. It is scored on a 1- to 5-point Likert scale where 1 = never or very rarely true and 5 = very often or always true. Mean scores are reported with a range from 1 to 5 where higher scores indicate more mindful awareness.

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale T1 Baseline	3.04 score on a scale Standard Deviation 0.59	2.91 score on a scale Standard Deviation 0.91
Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale T2 Post-test Week 4	3.22 score on a scale Standard Deviation 0.71	3.30 score on a scale Standard Deviation 0.74
Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale Change	0.16 score on a scale Standard Deviation 0.63	0.37 score on a scale Standard Deviation 0.81

SECONDARY outcome

Timeframe: Baseline, and post-test (week 4)

Population: 3 participants withdrew from the study

NIH Toolbox Loneliness is a 5-item questionnaire assessing loneliness. It is scored on a 1- to 5-point Likert scale where 1 = never and 5 = always. Mean scores are reported for a range from 1 to 5 where higher scores indicate more loneliness.

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Change in NIH Toolbox Loneliness T1 Baseline	2.76 score on a scale Standard Deviation 0.92	2.82 score on a scale Standard Deviation 1.01
Change in NIH Toolbox Loneliness T2 Post-test Week 4	2.20 score on a scale Standard Deviation 1.02	2.11 score on a scale Standard Deviation 0.87
Change in NIH Toolbox Loneliness Change	-0.54 score on a scale Standard Deviation 0.65	-0.75 score on a scale Standard Deviation 0.99

SECONDARY outcome

Timeframe: Baseline, and post-test (week 4)

Population: 3 participants withdrew from the study

Experiences Questionnaire Decentering is an 11-item questionnaire assessing the psychological capacity of decentering. It is scored on a 1- to 5-point Likert scale where 1 = never and 5 = all the time. Mean scores are reported for a total range from 1 to 5 where higher scores indicate more decentering.

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Change in Experiences Questionnaire (EQ) Decentering Subscale T1 Baseline	2.85 score on a scale Standard Deviation 0.53	3.06 score on a scale Standard Deviation 0.55
Change in Experiences Questionnaire (EQ) Decentering Subscale T2 Post-test Week 4	3.30 score on a scale Standard Deviation 0.68	3.56 score on a scale Standard Deviation 0.63
Change in Experiences Questionnaire (EQ) Decentering Subscale Change	0.46 score on a scale Standard Deviation 0.55	0.52 score on a scale Standard Deviation 0.71

SECONDARY outcome

Timeframe: Baseline, and post-test (week 4)

Population: 3 participants withdrew from the study

MLQ Presence is a 5-item questionnaire assessing the presence of meaning in life. It is scored on a 1- to 7-point Likert scale where 1 = absolutely untrue and 7 = absolutely true. Mean scores are reported for a total range from 1 to 7 where higher scores indicate greater presence of meaning in life.

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Change in Meaning in Life Questionnaire (MLQ) Presence Subscale T1 Baseline	3.58 score on a scale Standard Deviation 147	3.62 score on a scale Standard Deviation 1.50
Change in Meaning in Life Questionnaire (MLQ) Presence Subscale T2 Post-test Week 4	4.27 score on a scale Standard Deviation 1.36	4.53 score on a scale Standard Deviation 1.31
Change in Meaning in Life Questionnaire (MLQ) Presence Subscale Change	0.74 score on a scale Standard Deviation 1.08	0.93 score on a scale Standard Deviation 1.29

SECONDARY outcome

Timeframe: Baseline, and post-test (week 4)

Population: 3 participants withdrew from the study

Sleep disturbance will be assessed using the computer adaptive version of the PROMIS Sleep Disturbance measure. This measure produces scores a T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate greater sleep disturbance.

Outcome measures

Outcome measures
Measure	5-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=46 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Change in PROMIS Sleep Disturbance T1 Baseline	55.56 T-score Standard Deviation 7.04	53.77 T-score Standard Deviation 5.81
Change in PROMIS Sleep Disturbance T2 Post-Test Week 4	50.23 T-score Standard Deviation 8.70	48.84 T-score Standard Deviation 8.19
Change in PROMIS Sleep Disturbance Change	-5.20 T-score Standard Deviation 6.72	-5.04 T-score Standard Deviation 9.31

SECONDARY outcome

Timeframe: up to 4 weeks

Population: 3 participants withdrew from the study prior to the post-test measure, 1 participant did not answer the question

Participants were asked a single survey item to assess their meditation experience. The query was "I had challenging, difficult, or distressing experiences as a result of my meditation during this study." Participants chose from the following responses: Never, Rarely, Occasionally, Regularly, or Frequently. Count of participants in each arm answering each response is reported here.

Outcome measures

Outcome measures
Measure	5-minute App Usage n=44 Participants Participants will be asked to use the HMP app for 5-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.	15-minute App Usage n=44 Participants Participants will be asked to use the HMP app for 15-minutes per day. The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
Count of Participant Responses to Adverse Event Relevant Survey Item Never	30 Participants	33 Participants
Count of Participant Responses to Adverse Event Relevant Survey Item Rarely	9 Participants	5 Participants
Count of Participant Responses to Adverse Event Relevant Survey Item Occasionally	4 Participants	4 Participants
Count of Participant Responses to Adverse Event Relevant Survey Item Regularly	1 Participants	1 Participants
Count of Participant Responses to Adverse Event Relevant Survey Item Frequently	0 Participants	1 Participants

Adverse Events

5-minute App Usage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

15-minute App Usage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Simon B. Goldberg, PhD

Center for Healthy Minds, University of Wisconsin - Madison

Phone: 608-265-8986

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place