DepressionBeWellNCT05183867
Behavior, Biology and Well-Being Study
A study testing Healthy Minds Program in people with Depression and Psychological Distress, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The central aim of this study is to test the efficacy of the Healthy Minds Program (HMP) app, an intervention designed to promote well-being. The investigators plan to conduct a randomized controlled trial (RCT) involving 1100 participants comparing 4-weeks of the HMP app with an active control (Psychoeducation [HMP… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Psychological Distress
- What is being tested?
- Healthy Minds Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,157 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elevated PHQ-8 or PHQ-9 ≥ 5 at screening
- Proficient in English
- Able to provide informed consent
- Have access to a smartphone that can download apps from Google Play or the Apple App Store
- For payment purposes, must be a US citizen or a permanent US resident
Who cannot join
- Regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months
- Attended a meditation retreat or a yoga/body practice retreat with a significant meditation component
- Previous use of Healthy Minds Program app
- Current suicidal intent and/or high self-injury risk (determined from the interview)
- Self-reported history of psychosis
- Self-reported history of mania
Show all 10Show fewer
- Current psychopathology that interferes with study participation as assessed by interview
- Living or traveling outside the US during the whole study participation period (trips outside US after the interview phase is not an exclusion)
- Alcohol Use Disorders Identification Test (AUDIT) score ≥ 13 for women and AUDIT score ≥ 15 for men
- Drug Use Disorders Identification Test (DUDIT) score ≥ 8 for women and men
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Healthy Minds Program With an Active Control and Waitlist Control in Depression
The central aim of this study is to test the efficacy of the Healthy Minds Program (HMP) app, an intervention designed to promote well-being. The investigators plan to conduct a randomized controlled trial (RCT) involving 1100 participants comparing 4-weeks of the HMP app with an active control (Psychoeducation [HMP without meditation practice]), and a waitlist control in a sample of United States adults with elevated depression symptoms.
Read the detailed description
Depression is highly prevalent and associated with extreme personal and societal costs. Meditation training reduces depression symptoms and psychological distress, but access to in-person programs is limited due to associated cost and lack of available services. Research on neurocognitive and biological mechanisms of meditation training in alleviating depression is at a preliminary stage, and an obstacle limiting research progress is over-reliance on retrospective self-report measures, which are vulnerable to a host of biases. This project will use gold-standard behavioral measures and explore novel measures of relevant neurocognitive and behavioral processes, namely pattern separation, self-referential thought, and video-based assessment of emotional well-being. Furthermore, the project will investigate effects on the gut microbiome (with fecal samples) and inflammation (with dried blood spots), which reflect biological systems hypothesized to be mechanistically related to benefits of meditation and well-being training.
- Conditions
- Depression, Psychological Distress
- Being tested
- Healthy Minds Program
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Minds ProgramDevice
Also called HMP
HMP is a 4-week mobile health (mHealth) meditation training program.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Minds Program (HMP) app | Experimental | Participants will receive access to the 4-week HMP Foundations module. 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 is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice. Receives: Device: Healthy Minds Program |
| Psychoeducation app | Active comparator | Participants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices. Receives: Device: Healthy Minds Program |
| Usual Care | No intervention | Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
The PHQ-8 is an 8-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-24 where higher scores indicate more depressive symptoms.
Measured: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Secondary outcomes (22)
Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score
The GAD-7 is a 7-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-21 where higher scores indicate more anxious symptoms.
Measured: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
The PROMIS Sleep Disturbance scale is a computer-adaptive measure where participants report how often in the past 7 days they had various sleep-related experiences (e.g., "my sleep was restful"). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, standard deviation (SD) = 10) where higher scores indicate more sleep disturbance.
Measured: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Flourishing Measured by the Flourishing Index Score
The Flourishing Index is a 10-item questionnaire where participants report their general level of flourishing (e.g., well-being, health, etc.). It is scored on a 0 to 10-point scale, with anchors varying across items. The total score ranges from 0 to 100 with higher scores indicating higher flourishing.
Measured: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score
The Five Facet Mindfulness Questionnaire Acting with Awareness Subscale is a 8-item subscale where participants report on their general ability to focus. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater ability to focus.
Measured: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Connection Measured by NIH Toolbox Loneliness Score
The NIH Toolbox Loneliness is a 5-item questionnaire where participants report how often in the past week they have felt loneliness. It is scored on a 5-point Likert scale where 1 = never to 5 = always. The total possible range of scores is 5-25 where higher scores indicate a greater sense of loneliness.
Measured: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score
The Decentering subscale of the Experience Questionnaire is an 11-item questionnaire where participants report on their ability to decenter from their experience. It is scored on a 5-point Likert scale where 1 = never to 5 = all the time. The total possible range of scores is 11-55 where higher scores indicate a greater ability to decenter from experience.
Measured: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score
The PROMIS / NIH Toolbox Meaning and Purpose is a computer-adaptive measure where participants report how much meaning and purpose they experience in life (e.g., "I understand my life's meaning"). It is scored on a 5-point Likert scale where 1 = strongly disagree to 5 = strongly agree. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more meaning and purpose in life.
Measured: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Pain Intensity Measured by PROMIS Pain Intensity Score
The single-item PROMIS Pain Intensity scale is a 1-item scale where participants report on their pain intensity in the past 7 days. It is scored on an 11-point Likert-scale where 0 = no pain and 10 = worst pain imaginable. Scores range from 0 to 10, with higher scores indicating higher pain intensity
Measured: Baseline, week 4 (of intervention period), and 3 month follow-up
Pain Interference Measured by PROMIS Pain Inference Scale Score
The PROMIS Pain Interference scale is a computer-adaptive measure where participants report how often in the past 7 days they had pain-related interference in their life (e.g., "how much did pain interfere with your enjoyment of life"). It is scored on a 5-point Likert scale where 1 = not at all to 5 = very much. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more pain interference.
Measured: Baseline, week 4 (of intervention period), and 3 month follow-up
Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score
The Five Facet Mindfulness Questionnaire Nonjudgment Subscale is a 8-item subscale where participants report on their nonjudgment of experience in daily life. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater nonjudgment of experience.
Measured: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Climate Change Anxiety Scale
The Climate Change Anxiety Scale is a 13-item scale where participants report their anxiety regarding climate change (e.g., "I have nightmares about climate change"). It is scored on a 5-point Likert scale where 1 = "never" to 5 = "almost always." Total scores range from 13 to 65 where higher scores indicate greater climate change anxiety.
Measured: Baseline, week 4, and 3 month follow up
Wellbeing Growth Mindset
The Wellbeing Growth Mindset scale is a 3-item scale where participants report whether they believe wellbeing is malleable (e.g., "Your well-being is something about you that you can't change very much."). It is scored on a 6-point Likert scale where 1 = "strongly disagree" to 6 = "strongly agree." Total scores range from 3 to 18 where higher scores indicate greater wellbeing growth mindset.
Measured: Baseline, week 4, and 3 month follow up
Healthy Minds Index (HM Index) - Awareness
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 Awareness subscale is 0 to 16 where higher scores indicate more awareness.
Measured: Baseline, week 4, and 3 month follow up
Healthy Minds Index (HM Index) - Connection
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 Connection subscale range from 0 to 24, where higher scores indicate more connection.
Measured: Baseline, week 4, and 3 month follow up
Healthy Minds Index (HM Index) - Insight
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 Insight subscale range from 0 to 12, where higher scores indicate more insight.
Measured: Baseline, week 4, and 3 month follow up
Healthy Minds Index (HM Index) - Purpose
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 Purpose subscale range from 0 to 16, where higher scores indicate more purpose.
Measured: Baseline, week 4, and 3 month follow up
Life Orientation Test - Revised
The Life Orientation Test - Revised is a 6-item scale where participants report their level of optimism (e.g., "In uncertain times, I usually expect the best"). It is scored on a 5-point Likert scale where 0 = "strongly disagree" to 4 = "strongly agree." Total scores range from 0 to 24 where higher scores indicate greater optimism.
Measured: Baseline, week 4, and 3 month follow up
Perceived Stress Scale
The Perceived Stress Scale is a 10-item scale where participants report their level of perceived stress (e.g., "In the last month, how often have you felt nervous and 'stressed'?"). It is scored on a 5-point Likert scale where 0 = "never" to 4 = "very often." Total scores range from 0 to 40 where higher scores indicate greater perceived stress.
Measured: Baseline, week 4, and 3 month follow up
Perseverative Thinking Questionnaire
The Perseverative Thinking Questionnaire is a 15-item scale where participants report their level of repetitive negative thinking (e.g., "My thoughts repeat themselves"). It is scored on a 5-point Likert scale where 0 = "never" to 4 = "almost always." Total scores range from 0 to 60 where higher scores indicate greater perseverative thinking.
Measured: Baseline, week 4, and 3 month follow up
Satisfaction With Life Scale
The Satisfaction with Life Scale is a 5-item scale where participants report their level of satisfaction with life (e.g., "In most ways my life is close to ideal"). It is scored on a 7-point Likert scale where 1 = "strongly disagree" to 7 = "strongly agree." Total scores range from 5 to 35 where higher scores indicate greater satisfaction with life.
Measured: Baseline, week 4, and 3 month follow up
Subjective Happiness Scale
The Subjective Happiness Scale is a 4-item scale where participants report their level of subjective happiness (e.g., "In general, I consider myself [not a very happy person, a very happy person]"). It is scored on a 7-point Likert scale where 1 = less happy to 7 = more happy. Total scores range from 4 to 28 where higher scores indicate greater subjective happiness.
Measured: Baseline, week 4, and 3 month follow up
Problematic and Risky Internet Use Screening Scale (PRIUSS-3)
The PRIUSS-3 is a 3-item scale where participants report their level of problematic internet use. It is scored on a 4-point Likert scale where 0 = never to 4 = very often. Total scores range from 0 to 12, where higher scores indicate more problematic internet use.
Measured: Baseline, week 4, and 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jun 2022
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Model description
- The groups will be randomized to one of three groups in a 2:2:1 ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Hope for Depression Research Foundation, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Simon Goldberg, PhD, Principal investigator, UW-Madison, Center for Healthy Minds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183867
- Sponsor's protocol ID
- 2021-0991
- Other IDs
- Protocol Version 6/29/2023, A487400, 1U24AT011289-01
- Acronym
- BeWell
- Status last verified
- Aug 2026
- First submitted
- 21 Dec 2021
- Last updated
- 21 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Healthy Minds Program With an Active Control and Waitlist Control in Depression
- ClinicalTrials.gov ID
- NCT05183867
- Acronym / sponsor ID
- BeWell / 2021-0991
- Conditions
- Depression, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,157 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Hope for Depression Research Foundation, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Posted 1 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The central aim of this study is to test the efficacy of the Healthy Minds Program (HMP) app, an intervention designed to promote well-being. The investigators plan to conduct a randomized controlled trial (RCT) involving 1100 participants comparing 4-weeks of the HMP app with an active control (Psychoeducation [HMP without meditation practice]), and a waitlist control in a sample of United States adults with elevated depression symptoms.
Detailed description
Depression is highly prevalent and associated with extreme personal and societal costs. Meditation training reduces depression symptoms and psychological distress, but access to in-person programs is limited due to associated cost and lack of available services. Research on neurocognitive and biological mechanisms of meditation training in alleviating depression is at a preliminary stage, and an obstacle limiting research progress is over-reliance on retrospective self-report measures, which are vulnerable to a host of biases. This project will use gold-standard behavioral measures and explore novel measures of relevant neurocognitive and behavioral processes, namely pattern separation, self-referential thought, and video-based assessment of emotional well-being. Furthermore, the project will investigate effects on the gut microbiome (with fecal samples) and inflammation (with dried blood spots), which reflect biological systems hypothesized to be mechanistically related to benefits of meditation and well-being training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The groups will be randomized to one of three groups in a 2:2:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Healthy Minds Program (HMP) app | Experimental | Device: Healthy Minds ProgramParticipants will receive access to the 4-week HMP Foundations module. 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 is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). The full HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. At post-treatment, participants will be given access to additional HMP content to support their continued practice. |
| Psychoeducation app | Active comparator | Device: Healthy Minds ProgramParticipants will receive access to the 4-week HMP Foundations module with guided meditation practices removed. The active control will include only the didactic content included in HMP without the guided meditation practices. |
| Usual Care | No intervention | –Participants will receive access to HMP at the end of the study and will be encouraged to continue with their usual care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elevated PHQ-8 or PHQ-9 ≥ 5 at screening
- Proficient in English
- Able to provide informed consent
- Have access to a smartphone that can download apps from Google Play or the Apple App Store
- For payment purposes, must be a US citizen or a permanent US resident
Key exclusion criteria (10 listed)
- Regular daily meditation practice for past 6 months or regular weekly meditation practice for past 12 months
- Attended a meditation retreat or a yoga/body practice retreat with a significant meditation component
- Current suicidal intent and/or high self-injury risk (determined from the interview)
- Self-reported history of psychosis
- Self-reported history of mania
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 |
|---|---|---|
| Healthy Minds ProgramAlso: HMPHMP is a 4-week mobile health (mHealth) meditation training program. | Device | Healthy Minds Program (HMP) app, Psychoeducation app |
Primary outcome
Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
The PHQ-8 is an 8-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day. The total possible range of scores is 0-24 where higher scores indicate more depressive symptoms.
22 secondary outcomes
Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Flourishing Measured by the Flourishing Index Score
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Awareness Measured by Five Facet Mindfulness Questionnaire Acting With Awareness Subscale Score
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Connection Measured by NIH Toolbox Loneliness Score
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Decentering Measured by Decentering Subscale of Experiencing Questionnaire Scale Score
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Pain Intensity Measured by PROMIS Pain Intensity Score
Time frame: Baseline, week 4 (of intervention period), and 3 month follow-up
Pain Interference Measured by PROMIS Pain Inference Scale Score
Time frame: Baseline, week 4 (of intervention period), and 3 month follow-up
Nonjudgment Measured by Five Facet Mindfulness Questionnaire Nonjudgment Subscale Score
Time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up
Climate Change Anxiety Scale
Time frame: Baseline, week 4, and 3 month follow up
Wellbeing Growth Mindset
Time frame: Baseline, week 4, and 3 month follow up
Healthy Minds Index (HM Index) - Awareness
Time frame: Baseline, week 4, and 3 month follow up
Healthy Minds Index (HM Index) - Connection
Time frame: Baseline, week 4, and 3 month follow up
Healthy Minds Index (HM Index) - Insight
Time frame: Baseline, week 4, and 3 month follow up
Healthy Minds Index (HM Index) - Purpose
Time frame: Baseline, week 4, and 3 month follow up
Life Orientation Test - Revised
Time frame: Baseline, week 4, and 3 month follow up
Perceived Stress Scale
Time frame: Baseline, week 4, and 3 month follow up
Perseverative Thinking Questionnaire
Time frame: Baseline, week 4, and 3 month follow up
Satisfaction With Life Scale
Time frame: Baseline, week 4, and 3 month follow up
Subjective Happiness Scale
Time frame: Baseline, week 4, and 3 month follow up
Problematic and Risky Internet Use Screening Scale (PRIUSS-3)
Time frame: Baseline, week 4, and 3 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
UW-Madison, Center for Healthy Minds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Minds Program in people with Depression and Psychological Distress, 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 5 inclusion and 10 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 21 Sep 2026. 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?
Yes. Results are posted in the registry (first posted 1 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Depression Symptoms Measured by Patient Health Questionnaire - 8 (PHQ-8) Score (time frame: Baseline, week 1, week 2, week 3, week 4 (of intervention period), and 3 month follow-up). 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 21 Sep 2026.