Healthy Minds Program App Dosage

Phase 1

Completed

Conditions: Psychological Distress
Anxiety
Depression

Interventions: Behavioral: HMP app

Registration Number: NCT05229406

Lead Sponsor: University of Wisconsin, Madison

Brief Summary: The study will evaluate the effectiveness of the Healthy Minds Program (HMP) meditation app on participants experiencing depression and/or anxiety. Participants will be assigned to use the HMP app 5- or 15-minutes per day for 4 weeks.

Detailed Description: Depression and anxiety are highly common, but access to evidence-based treatments is limited. Meditation training delivered through mobile health (mHealth) technology may increase access to effective strategies. However, the necessary dosage of meditation practice to produce benefits is unknown. This project will investigate the feasibility, acceptability, and preliminary effectiveness of the HMP app for depression and/or anxiety and the feasibility of randomly assigning participants to practice dosages. Further, the project will provide a preliminary evaluation of the linkages between practice dosage and outcomes assessed retrospectively and in-the-moment via ecological momentary assessment (EMA).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 92

Inclusion Criteria

Age 18 or older
Access to a smartphone or device capable of downloading HMP app
Self-reported willingness to complete 1-2 min survey 4 times per day on phone for 4 weeks
Able to speak, read, and write in English
PROMIS Depression or PROMIS Anxiety >55

Exclusion Criteria

Meditation retreat experience
Regular meditation practice (weekly practice for over 1 year OR daily practice within the previous 6 months)
Previous practice under the instruction of a meditation teacher, other than in the context of an introductory course
PROMIS Depression >70
AUDIT C score greater than or equal to 4 for men, and greater than or equal to 3 for non-men (any other genders)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5-minute app usage	HMP app	Participants will be asked to use the HMP app for 5-minutes per day.
15-minute app usage	HMP app	Participants will be asked to use the HMP app for 15-minutes per day.

Primary Outcome Measures

Name	Time	Method
Modified System Usability Scale (MSUS)	Post-test (week 4)	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.
HMP App Utilization: Days	Baseline to post-test (week 4)	Number of days the app was accessed.
Dosage Adherence: Number of Participants Adhering to Their Dosage Greater Than or Equal to 50 Percent of the Days	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.
HMP App Utilization: Minutes	Baseline to post-test (week 4)	Minutes of meditation practice completed
HMP App Utilization: Number of Activities	Baseline to post-test (week 4)
Number of Participants Completing Practices ≥50% of Days	Baseline to post-test (week 4)	Number of participants completing practices ≥50% of days
Percentage of EMA Completed	Baseline to post-test (week 4)	Percentage of EMA assessments that were completed
Change in Attitudes Towards Psychological Online Interventions (ATPOI)	Baseline, and post-test (week 4)	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.
Randomization Rate: Number of Participants Who Were Randomized and Completed EMA Assessments and Activities in the HMP App	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
Study Completion Rate	Baseline to post-test (week 4)	Percentage of participants completing pre- and post-test measures

Secondary Outcome Measures

Name	Time	Method
Change in PROMIS Sleep Disturbance	Baseline, and post-test (week 4)	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.
Change in Experiences Questionnaire (EQ) Decentering Subscale	Baseline, and post-test (week 4)	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.
Change in Healthy Minds Index (HM Index): Awareness	Baseline, and post-test (week 4)	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.
Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale	Baseline, and post-test (week 4)	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.
Change in Healthy Minds Index (HM Index): Insight	Baseline, and post-test (week 4)	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.
Change in Healthy Minds Index (HM Index): Connection	Baseline, and post-test (week 4)	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.
Change in Healthy Minds Index (HM Index): Purpose	Baseline, and post-test (week 4)	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.
Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety	Baseline, and post-test (week 4)	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.
Change in Wellbeing Growth Mindset	Baseline, and post-test (week 4)	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).
Change in NIH Toolbox Loneliness	Baseline, and post-test (week 4)	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.
Change in Meaning in Life Questionnaire (MLQ) Presence Subscale	Baseline, and post-test (week 4)	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.
Count of Participant Responses to Adverse Event Relevant Survey Item	up to 4 weeks	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.