Healthy Minds Program App Dosage
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 5-minute app usage Participants will be asked to use the HMP app for 5-minutes per day. |
Behavioral: 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.
|
| Experimental: 15-minute app usage Participants will be asked to use the HMP app for 15-minutes per day. |
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- Randomization rate [Baseline to post-test (week 4)]
Percentage of those randomized completing EMA assessments and activities in the HMP app
- Dosage adherence [Baseline to post-test (week 4)]
Percentage of participants adhering to their assigned dosage
- EMA adherence [Baseline to post-test (week 4)]
Percentage of participants completing EMA assessments
- Study completion rate [Baseline to post-test (week 4)]
Percentage of participants completing pre- and post-test measures
- Practice completion [Baseline to post-test (week 4)]
Percentage of participants completing practices
- 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. A total possible range of scores is 10 to 50 where higher scores indicate higher usability.
- 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. A total possible range of scores is 16 to 80 where higher scores indicate more positive attitudes towards psychological online interventions.
- HMP app utilization [Baseline to post-test (week 4)]
Minutes, days, and activities completed in HMP app
Secondary Outcome Measures
- 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.
- Change in Healthy Minds Index (HM Index) [Baseline, and post-test (week 4)]
The HM Index is a 17-item questionnaire assessing 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. Total scores for the four subscales range as follows: Awareness (0 to 16), Connection (0 to 24), Insight (0 to 12), Purpose (0 to 16) where higher scores indicate more of each quality.
- 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 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. Total scores range from 8 to 40 where higher scores indicate more mindful awareness.
- 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. Total scores range from 5 to 25 where higher scores indicate more loneliness.
- 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. Total scores range from 11 to 55 where higher scores indicate more decentering.
- 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. Total scores range from 5 to 35 where higher scores indicate greater presence of meaning in life.
- 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.
Other Outcome Measures
- Change in EMA-assessed psychological distress (composite of depression and anxiety items) [4 times per day from baseline to post-test (week 4)]
A single item reflecting depression and a single item reflecting anxiety are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.
- Change in EMA-assessed mindfulness of activities [4 times per day from baseline to post-test (week 4)]
A single item mindfulness of activities is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.
- Change in EMA-assessed mindfulness of feelings / emotions [4 times per day from baseline to post-test (week 4)]
A single item assessing awareness of feelings is scored on a 1- to 5-point Likert scale where 1 = not at all aware and 5 = extremely aware.
- Change in EMA-assessed loneliness [4 times per day from baseline to post-test (week 4)]
A single item assessing loneliness is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.
- Change in EMA-assessed connection with others [4 times per day from baseline to post-test (week 4)]
A single item assessing connection with others is scored on a 1- to 5-point Likert scale where 1 = not often at all and 5 = extremely often
- Change in EMA-assessed decentering [4 times per day from baseline to post-test (week 4)]
A single item assessing decentering (i.e., experiencing thoughts more as events than direct reflection of reality) is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.
- Change in EMA-assessed insight [4 times per day from baseline to post-test (week 4)]
A single item assessing insight is scored on a 1- to 5-point Likert scale where 1 = not at all aware and 5 = extremely aware
- Change in EMA-assessed purpose [4 times per day from baseline to post-test (week 4)]
A single item assessing purpose is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much
- Change in EMA-assessed stressor exposure [4 times per day from baseline to post-test (week 4)]
A single item assessing stressor exposure is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.
- Change in EMA-assessed personal values / meaning [4 times per day from baseline to post-test (week 4)]
A single item assessing reflection of personal values in current activity is scored on a 1- to 5-point Likert scale where 1 = not at all reflected and 5 = extremely reflected.
- Change in EMA-assessed rumination [4 times per day from baseline to post-test (week 4)]
A single item assessing rumination is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much
- Change in EMA-assessed informal practice [4 times per day from baseline to post-test (week 4)]
A single item assessing application of meditation techniques in daily life (informal practice) is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.
- Change in pre- and post-practice positive affect [Before and after meditation practices between baseline and post-test (week 4)]
Two items assessing positive affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.
- Change in pre- and post-practice negative affect [Before and after meditation practices between baseline and post-test (week 4)]
Two items assessing negative affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much
- Change in post-practice focus [Before and after meditation practices between baseline and post-test (week 4)]
A single item assessing focus during meditation is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = most of the time
- Digital Working Alliance Inventory (DWAI) [Post-test (week 4)]
The DWAI is a 6-item questionnaire assessing participants' alliance with the HMP app. It is scored on a 1- to 7-point Likert scale where 1 = strongly disagree and 7 = strongly agree. Total scores range from 6 to 42 where higher scores indicate a stronger working alliance.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 or older
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Access to a smartphone or device capable of downloading HMP app
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Self-reported willingness to complete 1-2 min survey 4 times per day on phone for 4 weeks
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Able to speak, read, and write in English
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PROMIS Depression or PROMIS Anxiety >55
Exclusion Criteria:
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Meditation retreat experience
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Regular meditation practice (weekly practice for over 1 year OR daily practice within the previous 6 months)
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Previous practice under the instruction of a meditation teacher, other than in the context of an introductory course
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PROMIS Depression >70
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AUDIT C score greater than or equal to 4 for men, and greater than or equal to 3 for non-men (any other genders)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Wisconsin | Madison | Wisconsin | United States | 53705 |
Sponsors and Collaborators
- University of Wisconsin, Madison
- National Institutes of Health (NIH)
- National Center for Complementary and Integrative Health (NCCIH)
Investigators
- Principal Investigator: Simon Goldberg, PhD, University of Wisconsin, Madison
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-1578
- MSN227550
- 2019-1578
- A171600
- EDUC/COUNSELING PSYCH
- 01/21/2022
- 1K23AT010879-01