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Depression, AnxietyNCT04741529

Massed and Spaced HMP App Dosage Study

A study testing Healthy Minds Program app in people with Depression, Anxiety and Psychological Distress, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a randomized controlled trial (RCT) of 2 weeks of the Healthy Minds Program (HMP) app Connection module in undergraduate students of a large, midwestern state university in the United States during the spring of 2021. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Healthy Minds Program app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
351 participants
Where
1 siteUnited States
Study dates
9 Mar 2021to 18 May 2021
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

  • 18 years or older
  • Undergraduate at UW-Madison
  • Access to a smartphone or device capable of downloading HMP app
  • PROMIS Depression or PROMIS Anxiety ≥55

Who cannot join

  • Meditation retreat experience
  • Regular meditation practice (i.e., weekly practice for >1 year OR daily practice within previous 6 months)
  • Previous practice under the instruction of a meditation teacher, other than in the context of an introductory course
  • PROMIS Depression ≥70

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53706

Other trials in United States

About this study

Official title: Massed and Spaced Healthy Minds Program App Dosage Study

This study is a randomized controlled trial (RCT) of 2 weeks of the Healthy Minds Program (HMP) app Connection module in undergraduate students of a large, midwestern state university in the United States during the spring of 2021.

Participants will be recruited via email and/or flyers and will first complete an online screen. Eligible participants will complete baseline measures prior to attending an introductory session via web conferencing. During this session, participants will be randomly assigned to condition. Participants in both conditions will be asked to use the HMP app for 20 minutes per either, either split over two 10-minute session (Spaced condition) or in one 20-minute session (Massed condition). Participants will complete daily survey measures during the study and post-test measures after 2 weeks of intervention.

This study is primarily designed to assess feasibility and acceptability of 2 weeks of Connection training and assignment to dosage condition. Study team will investigate self-reported informal practice on the daily diary measure, measures of psychological distress (composite of depression, anxiety) and loneliness.

Being tested
Healthy Minds Program app
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.

  • Healthy Minds Program appBehavioural

    The HMP app was developed by Healthy Minds Innovations at the UW Center for Healthy Minds, and is based on the work of Drs. Richard Davidson and Cortland Dahl. HMP is 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 high-quality 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). HMP has >100 guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.

    Participants in this study will receive 2 weeks of training in the Connection module of HMP.

Study groups in NCT04741529
Study groupRoleWhat they receive
Massed conditionExperimentalParticipant will be asked to use the HMP app for 20 minutes per day in one 20-minute meditation session.
Receives: Behavioral: Healthy Minds Program app
Spaced conditionExperimentalParticipant will be asked to use the HMP app for 20 minutes per day in two 10-minute meditation sessions.
Receives: Behavioral: Healthy Minds Program app

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants who completed the study

    Measured: 2 weeks

  2. Number of meditation sessions per day using the HMP app

    Measured: 2 weeks

  3. Number of minutes of meditation practice using the HMP app

    Measured: 2 weeks

  4. System Usability Scale score

    System usability scale is (SUS) is a 10-item Likert scale questionnaire that provides information on the ease of use (or lack thereof) of websites, software, hardware, mobile devices, and other technological applications. Higher SUS score correlates to better usability of an app, total score range = 0 to 100

    Measured: 2 weeks

Secondary outcomes (10)

  1. Change in the PROMIS (Patient-Reported Outcomes Measurement Information System) Depression score

    Psychological distress computed as composite of 4-item PROMIS Depression measures. Scores range from 4 to 20 with higher scores representing worse symptoms.

    Measured: Baseline and 2 weeks

  2. Change in the PROMIS Anxiety score

    Psychological distress computed as composite of 4-item PROMIS Anxiety measures. Scores range from 4 to 20 with higher scores representing worse symptoms.

    Measured: Baseline and 2 weeks

  3. Change in NIH Toolbox Loneliness score

    NIH toolbox loneliness measures the perceptions that one is alone, lonely, or socially isolated from others. It is a 5-item scale. Total score range = 5 to 25, lower score is better

    Measured: Baseline and 2 weeks

  4. Change in Self-Compassion Short Form score

    This 12-item measure assesses participant's self-compassion ability, total score range = 12 to 60, higher scores correlate to more self-compassion.

    Measured: Baseline and 2 weeks

  5. Change in Fear of Missing Out scale score

    Fear of missing out is a 10 item scale. Total score range = 10 to 50, lower score is better

    Measured: Baseline and 2 weeks

  6. Change in Acceptance and Action Questionnaire - II score

    Acceptance and Action Questionnaire- II measures psychological flexibility Experiential avoidance, total score range = 7 to 49. Higher total scores mean less flexibility, while lower total scores mean more flexibility. Lower score is better.

    Measured: Baseline and 2 weeks

  7. Single item loneliness score

    "How lonely did you feel today?", range = 1 to 7, lower score is better

    Measured: Up to 2 weeks

  8. Highest loading PROMIS Depression and PROMIS Anxiety items score

    Composite of highest loading PROMIS items modified to reference "today," z-transformed to have mean of 0 and standard deviation of 1, lower score is better.

    Measured: Up to 2 weeks

  9. Single item informal meditation practice

    Single item informal meditation practice measure, "As you reflect on today, to what extent did you apply these practices?" Scores range from 0 to 100. A higher score is better.

    Measured: Up to 2 weeks

  10. Digital Working Alliance Inventory score

    The Digital Working Alliance Inventory measures the therapeutic relationship between participant and HMP app. Total score range = 6 to 42, higher score is better.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2021
  2. Study start9 Mar 2021
  3. Primary completion18 May 2021
  4. Study completion18 May 2021

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04741529
Sponsor's protocol ID
2020-1454
Other IDs
A171600, EDUC/COUNSELING PSYCH, Protocol Approval 1/11/2021
Status last verified
Jun 2021
First submitted
29 Jan 2021
Last updated
11 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be de-identified and listed in public data registries (i.e., osf) based on the publication of preregistered study hypotheses on a manuscript by manuscript basis.

Publications

  • Riordan KM, Simonsson O, Frye C, Vack NJ, Sachs J, Fitch D, Goldman RI, Chiang ES, Dahl CJ, Davidson RJ, Goldberg SB. How often should I meditate? A randomized trial examining the role of meditation frequency when total amount of meditation is held constant. J Couns Psychol. 2024 Mar;71(2):104-114. doi: 10.1037/cou0000725.

    PubMed 38376930

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Minds Program app in people with Depression, Anxiety 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 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 11 Jun 2021. 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?

Percentage of participants who completed the study (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04741529, which also lists 1 linked publication.

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 11 Jun 2021.

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