Healthy Minds Program App Dosage

Depression Clinical Trial

Official title:

Healthy Minds Program (HMP) App Dosage Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05229406
• Other study ID #: 2019-1578
• Secondary ID: MSN2275502019-15
• Status: Completed
• Phase: Phase 1
• Start date: February 21, 2022
• Est. completion date: June 27, 2022

Study information

• Verified date: July 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 27, 2022
• Est. primary completion date: June 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Depression
• Psychological Distress

Intervention

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.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in EMA-assessed Psychological Distress (Composite of Depression and Anxiety Items)	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.	4 times per day from baseline to post-test (week 4)
Other	Change in EMA-assessed Mindfulness of Activities	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.	4 times per day from baseline to post-test (week 4)
Other	Change in EMA-assessed Mindfulness of Feelings / Emotions	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.	4 times per day from baseline to post-test (week 4)
Other	Change in EMA-assessed Loneliness	A single item assessing loneliness is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.	4 times per day from baseline to post-test (week 4)
Other	Change in EMA-assessed Connection With Others	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	4 times per day from baseline to post-test (week 4)
Other	Change in EMA-assessed Decentering	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.	4 times per day from baseline to post-test (week 4)
Other	Change in EMA-assessed Insight	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	4 times per day from baseline to post-test (week 4)
Other	Change in EMA-assessed Purpose	A single item assessing purpose is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much	4 times per day from baseline to post-test (week 4)
Other	Change in EMA-assessed Stressor Exposure	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.	4 times per day from baseline to post-test (week 4)
Other	Change in EMA-assessed Personal Values / Meaning	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.	4 times per day from baseline to post-test (week 4)
Other	Change in EMA-assessed Rumination	A single item assessing rumination is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much	4 times per day from baseline to post-test (week 4)
Other	Change in EMA-assessed Informal Practice	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.	4 times per day from baseline to post-test (week 4)
Other	Change in Pre- and Post-practice Positive Affect	Two items assessing positive affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.	Before and after meditation practices between baseline and post-test (week 4)
Other	Change in Pre- and Post-practice Negative Affect	Two items assessing negative affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much	Before and after meditation practices between baseline and post-test (week 4)
Other	Change in Post-practice Focus	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	Before and after meditation practices between baseline and post-test (week 4)
Other	Digital Working Alliance Inventory (DWAI)	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.	Post-test (week 4)
Primary	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)
Primary	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)
Primary	Percentage of EMA Completed	Percentage of EMA assessments that were completed	Baseline to post-test (week 4)
Primary	Study Completion Rate	Percentage of participants completing pre- and post-test measures	Baseline to post-test (week 4)
Primary	Number of Participants Completing Practices =50% of Days	Number of participants completing practices =50% of days	Baseline to post-test (week 4)
Primary	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)
Primary	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)
Primary	HMP App Utilization: Minutes	Minutes of meditation practice completed	Baseline to post-test (week 4)
Primary	HMP App Utilization: Days	Number of days the app was accessed.	Baseline to post-test (week 4)
Primary	HMP App Utilization: Number of Activities		Baseline to post-test (week 4)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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