Healthy Minds Program App Dosage

Study Overview
=================
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).

Official Title
-----------------
Healthy Minds Program (HMP) App Dosage Study

Conditions
-----------------
Depression, Anxiety, Psychological Distress

Intervention / Treatment
-----------------
* Behavioral: HMP app


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to two groups in a 1:1 ratio
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5-minute app usage<br>Participants will be asked to use the HMP app for 5-minutes per day. | Behavioral: HMP app<br>* 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.<br>|
| Experimental: 15-minute app usage<br>Participants will be asked to use the HMP app for 15-minutes per day. | Behavioral: HMP app<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, anxiety, behavioral symptoms