DepressionNCT06282523
Healthy Minds Comparison Study
A study testing HMP app and HMRP web app in people with Depression and Anxiety, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal of this clinical trial is to understand the difference between two versions of the Healthy Minds application, a digital well-being program. The main question it aims to answer is the differences between versions of the Healthy Minds application and their effects on well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Depression/Anxiety
- What is being tested?
- HMP app and HMRP web app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 532 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Elevated symptoms of depression and anxiety
- Proficient in English
- Access to a smartphone
Who cannot join
- Prior experience with meditation generally
- Prior use of the Healthy Minds application
- History of psychosis or mania
- Alcohol and/or substance use disorder
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to understand the difference between two versions of the Healthy Minds application, a digital well-being program. The main question it aims to answer is the differences between versions of the Healthy Minds application and their effects on well-being.
Participants will complete an online four-week well-being program and complete surveys sent to their email. Participants can expect to participate in the study for four months.
- Conditions
- Depression, Anxiety, Depression/Anxiety
- Being tested
- HMP app, HMRP web app
- Keywords
- meditation, mindfulness
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMP appBehavioural
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.
HMRP web appBehavioural
The HMRP web app is a meditation-based web-based 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. HMRP provides core content, with instruction administered through a curriculum of guided practices. HMRP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Minds Program (HMP) - Awareness first | Experimental | Participants will be assigned to use the HMP mobile app on symptoms of psychological distress, and will complete the Awareness module first. Receives: Behavioral: HMP app |
| Healthy Minds Research Platform (HMRP) - Awareness first | Experimental | Participants will be assigned to use the HMRP web app on symptoms of psychological distress, and will complete the Awareness module first. Receives: Behavioral: HMRP web app |
| HMP - Connection first | Experimental | Participants will be assigned to use the HMP mobile app on symptoms of psychological distress, and will complete the Connection module first. Receives: Behavioral: HMP app |
| HMRP - Connection first | Experimental | Participants will be assigned to use the HMRP web app on symptoms of psychological distress, and will complete the Connection module first. Receives: Behavioral: HMRP web app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, weeks 1, 2, 3, 4, and 3 months
Secondary outcomes (17)
HMP App Utilization: Days
Number of days the app was accessed.
Measured: Study duration (4 weeks)
HMP App Utilization: Number of Activities
Number of activities completed
Measured: Study duration (4 weeks)
HMP App Utilization: Minutes
Minutes of meditation practice completed
Measured: Study duration (4 weeks)
Change in Healthy Minds Index (HM Index): Awareness
The HM Index assesses qualities trained in the HMP and HMRP 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.
Measured: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Healthy Minds Index (HM Index): Connection
The HM Index assesses qualities trained in the HMP and HMRP 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.
Measured: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Healthy Minds Index (HM Index): Purpose
The HM Index assesses qualities trained in the HMP and HMRP 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.
Measured: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Healthy Minds Index (HM Index): Insight
The HM Index assesses qualities trained in the HMP and HMRP 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.
Measured: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Subjective Happiness Scale
The SHS is a 4-item scale of global subjective happiness. It is scored on a 1- to 7-point Likert scale where 1 = less happy and 7 = more happy. Mean scores are reported for a range from 4 to 28 where higher scores indicate more happiness.
Measured: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Satisfaction with Life Scale (SWLS)
The SWLS is a 5-item scale of subjective satisfaction with life. It is scored on a 1- to 7-point Likert scale where 1 = strongly disagree and 7 = strongly agree. Mean scores are reported for a range from 5 to 35 where higher scores indicate greater satisfaction.
Measured: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Perceived Stress Scale (PSS-10)
The PSS-10 is a 10-item scale assessing perceived stress. It is scored on a 0- to 4-point Likert scale where 0 = never and 4 = very often. Mean scores are reported for a range from 0 to 40 where higher scores indicate greater stress.
Measured: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Flourishing Measure
This is a 12-item questionnaire used to assess various domains of flourishing, or human well-being. It is scored on a 0- to 10-point Likert scale where 0 = poor and 10 = excellent. Mean scores are reported for a range from 0 to 120 where higher scores indicate greater human well-being.
Measured: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Digital Working Alliance Inventory (DWAI)
The DWAI is a 6-item questionnaire assessing participants' alliance with the HMP and HMRP 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.
Measured: Baseline, weeks 1, 2, 3, 4, and 3 months
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.
Measured: Baseline, weeks 1, 2, 3, 4, and 3 months
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.
Measured: Baseline, weeks 1, 2, 3, 4, and 3 months
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.
Measured: Baseline, weeks 1, 2, 3, 4, and 3 months
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).
Measured: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose
PROMIS Meaning and Purpose is a 37-item questionnaire assessing sense of meaning and purpose. It is scored on a 1- to 5-point Likert scale where 1 = not at all and 5 = very much. Mean scores are reported for a range from 37 to 185 where higher scores indicate greater sense of meaning and purpose.
Measured: Baseline, weeks 1, 2, 3, 4, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start19 Jun 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Goldberg, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282523
- Sponsor's protocol ID
- 2023-1773
- Other IDs
- A171600, EDUC/COUNSELING PSYCH, Protocol Version 12/27/23
- Status last verified
- Jan 2025
- First submitted
- 21 Feb 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Minds Comparison Study
- ClinicalTrials.gov ID
- NCT06282523
- Acronym / sponsor ID
- 2023-1773
- Conditions
- Depression, Anxiety, Depression/Anxiety
- Keywords
- meditation, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to understand the difference between two versions of the Healthy Minds application, a digital well-being program. The main question it aims to answer is the differences between versions of the Healthy Minds application and their effects on well-being.
Participants will complete an online four-week well-being program and complete surveys sent to their email. Participants can expect to participate in the study for four months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Minds Program (HMP) - Awareness first | Experimental | Behavioral: HMP appParticipants will be assigned to use the HMP mobile app on symptoms of psychological distress, and will complete the Awareness module first. |
| Healthy Minds Research Platform (HMRP) - Awareness first | Experimental | Behavioral: HMRP web appParticipants will be assigned to use the HMRP web app on symptoms of psychological distress, and will complete the Awareness module first. |
| HMP - Connection first | Experimental | Behavioral: HMP appParticipants will be assigned to use the HMP mobile app on symptoms of psychological distress, and will complete the Connection module first. |
| HMRP - Connection first | Experimental | Behavioral: HMRP web appParticipants will be assigned to use the HMRP web app on symptoms of psychological distress, and will complete the Connection module first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Elevated symptoms of depression and anxiety
- Proficient in English
- Access to a smartphone
Key exclusion criteria (4 listed)
- Prior experience with meditation generally
- Prior use of the Healthy Minds application
- History of psychosis or mania
- Alcohol and/or substance use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMP appThe 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. | Behavioural | HMP - Connection first, Healthy Minds Program (HMP) - Awareness first |
| HMRP web appThe HMRP web app is a meditation-based web-based 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. HMRP provides core content, with instruction administered through a curriculum of guided practices. HMRP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. | Behavioural | HMRP - Connection first, Healthy Minds Research Platform (HMRP) - Awareness first |
Primary outcome
Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety
Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months
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.
17 secondary outcomes
HMP App Utilization: Days
Time frame: Study duration (4 weeks)
HMP App Utilization: Number of Activities
Time frame: Study duration (4 weeks)
HMP App Utilization: Minutes
Time frame: Study duration (4 weeks)
Change in Healthy Minds Index (HM Index): Awareness
Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Healthy Minds Index (HM Index): Connection
Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Healthy Minds Index (HM Index): Purpose
Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Healthy Minds Index (HM Index): Insight
Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Subjective Happiness Scale
Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Satisfaction with Life Scale (SWLS)
Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Perceived Stress Scale (PSS-10)
Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Flourishing Measure
Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Digital Working Alliance Inventory (DWAI)
Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Experiences Questionnaire (EQ) Decentering Subscale
Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale
Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in NIH Toolbox Loneliness
Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Wellbeing Growth Mindset
Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose
Time frame: Baseline, weeks 1, 2, 3, 4, and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Goldberg, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMP app and HMRP web app in people with Depression and Anxiety, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety (time frame: Baseline, weeks 1, 2, 3, 4, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.