Healthy Minds Program (HMP) App Dosage Study
Phase: PHASE1
Conditions: Depression, Anxiety, Psychological Distress
Sponsor: University of Wisconsin, Madison

 
 
Healthy Minds Program (HMP) App Dosage Study 
Basic Study Information 
 
Simon Goldberg, PhD 
 
NCT05229406 
 
 
 
 
 
 
 
 
 
 
Minimal Risk Research Institutional Review Board 
IRB Approval Date: 10/19/2022 
 
 
 
 
[compiled from the non-protocol based IRB application] 

Healthy Minds Program App Dosage Study 
 
Principal Investigator: Simon Goldberg 
 
Funding: Mindfulness training delivered via mobile health to reduce depression and 
anxiety 
1K23AT010879-01   
 
Overall Purpose 
This study will investigate the impact of dosage of meditation practice delivered via a 
mobile health smartphone application (Healthy Minds Program app) on symptoms of 
depression and anxiety. We will also investigate the feasibility and acceptability of this 
program among individuals with elevated symptoms of depression and/or anxiety at 
baseline. 
 
Study Procedures and Interventions 
We anticipate enrolling 110 participants into the study. Recruitment will take place via 
email, newspaper advertisements, Craigslist, clinics, and flyers. Interested individuals 
will complete a webscreen to determine eligibility. After passing the webscreen, they will 
be provided with an overview of the study and will have the option to enroll via an online 
consent process. 
 
Participants will be asked to complete T1 surveys. After completing T1 surveys, they will 
be contacted by study staff and assigned to a dosage condition (low dosage = 5 
minutes per day, high dosage = 15 minutes per day). Study staff will assist with 
downloading the mobile app, briefly introducing the participant to the meditation 
practices, and answering any questions about the practices and/or study. Participants 
will complete EMA assessments (brief questionnaires delivered as text messages to 
participants' mobile phones) throughout the duration of the study. Four EMA 
questionnaires will be delivered per day at random times interspersed between the 
hours of 9am and 7pm. Participants will complete T2 surveys approximately 4 weeks 

after T1. Participants may be invited to an exit interview after completion of the study in 
order to give feedback on the study. 
 
- Attitudes Towards Psychological Online Interventions (T1, T2) 
- AUDIT C (screening only) 
- Big Five Inventory, Conscientiousness Items (T1 only) 
- Demographics (T1 only) 
- Digital Working Alliance Inventory (T2 only) 
- EMA items (daily throughout study) 
- Experiences Questionnaire decentering subscale (T1, T2) 
- Five Facet Mindfulness Questionnaire awareness subscale (T1, T2) 
- Healthy Minds Index (T1, T2) 
- Marlowe Crowne Social Desirability Scale (T1 only) 
- Meaning in Life Questionnaire presence subscale (T1, T2) 
- Medication and Therapy Questionnaire (T1, T2) 
- Meditation Related Adverse Effects (T2 only) 
- Mindfulness Adherence Questionnaire (T2 only) 
- NIH Toolbox Loneliness (T1, T2) 
- Perseverative Thinking Questionnaire (T1, T2) 
- Pre/Post Practice Items (daily throughout study) 
- PROMIS Anxiety and Depression Scales (screening, T1, T2) 
- PROMIS Sleep Disturbance Scale (T1, T2) 
- System Usability Scale (T2 only) 
- Well-Being Growth Mindset (T1, T2) 
- Qualitative interview questions (T2 only) 
- How heard about the study (screening only) 
 
HMP app: After randomization, participants will be asked to spend either 5 minutes or 
15 minutes per day practicing meditation with guidance through the HMP smartphone 
app. The HMP app was developed by Healthy Minds Innovations at the UW Center for 
Healthy Minds, and is based on the work of Richard Davidson, PhD. It is designed to 

promote psychological well-being through well-being skills training. HMP provides 
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). Participants will be instructed to use practices from the 
Awareness module of the HMP app. These attention skills are associated with a number 
of positive outcomes, including better physical and mental health and increased school 
and job success. Importantly, evidence increasingly suggests that these attention and 
awareness skills, specifically, can improve with meditation training. Within the context of 
the current study, the HMP app is being considered a general wellness device rather 
than a medical treatment. 
 
Usage data: We will collect information on when and for how long participants listen to 
recordings, which recordings, and for how long through the application itself. Usage 
data will be collected through the app itself as well as through EMA questions. 
Information on their device make, model, and operating system is also collected through 
the application for quality assurance purposes. All data collected through the application 
is stored on Amazon Web Services (AWS). All data is encrypted, both at rest (when it is 
in a database) and in transit (e.g., when it is moving between the application and AWS 
services). No identifying information, such as IP address, is stored by the application. 
Data collected through the application will only be identified by study ID numbers. 
 
Potential Benefits to Society 
This program offers an innovative public health approach to reducing the burden of 
depression and anxiety. By investigating the impact of dosage, we will understand the 
amount of practice that may be necessary to produce clinical benefits. 
 
Inclusion Criteria 
1. Elevated symptoms of depression and anxiety. 
2. Age 18 or older. 
3. Proficient in English. 

Exclusion Criteria 
1. Non-elevated symptoms of depression and anxiety or having a t-score greater 
than 70 on the depression scale. 
2. Age 17 or younger. 
3. Significant meditation experience (as defined below): 
- Meditation retreat experience (meditation retreat or yoga/body practice 
retreat with significant meditation component). 
- Regular meditation practice weekly 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. 
4. Elevated scores on the Audit-C (greater than or equal to 4 for men and greater 
than or equal to 3 for women). 
5. No access to a smartphone capable of running the HMP app. 
6. Self-reported unwillingness to complete EMA surveys 4 times per day during 
the 4 week study. 
 
Recruitment Plan 
These are the primary tools we plan to use for recruitment: 
1) Flyers: We intend to post in neighborhood settings (e.g., grocery stores, 
libraries, community centers). We may post at area clinics as well. 
2) Email: We anticipate using DoIT to email members of the UW-Madison 
campus community. We may also email UW-Madison community contacts and 
Madison community contacts directly. 
3) Newspaper: We anticipate posting advertisements for the study in local 
newspapers (e.g., The Isthmus). 
4) Craigslist (under research heading). 
Targeted versions of recruitment materials may be used to increase enrollment from 
underrepresented groups. 
 
 

Sharing of Data 
De-identified data will be made available upon request or shared publicly in an open 
science format, consistent with NIH data sharing guidelines. 
Data that is shared upon request or shared publicly will be completely stripped of HIPAA 
identifiers including dates.