University of Wisconsin
Madison, Wisconsin, 53705, United States
NCT Number: NCT05229406
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.
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Notify Me18 year–99 year
All sexes
Interventional
Phase 1
Madison, Wisconsin, 53705, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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
Time frame: 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.
Time frame: Baseline to post-test (week 4)
Percentage of EMA assessments that were completed
Time frame: Baseline to post-test (week 4)
Percentage of participants completing pre- and post-test measures
Time frame: Baseline to post-test (week 4)
Number of participants completing practices ≥50% of days
Time frame: 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.
Time frame: 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.
Time frame: Baseline to post-test (week 4)
Minutes of meditation practice completed
Time frame: Baseline to post-test (week 4)
Number of days the app was accessed.
Time frame: Baseline to post-test (week 4)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
University of Wisconsin, Madison
Other
Healthy Minds Program (HMP) App Dosage Study
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