The COMParing App Support Strategies Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Introductory Coaching Session, Introductory Information Session, On-Demand Email Support, Microsupport.
- Who it may be relevant to
- Registry conditions: Depression, Anxiety. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The overall purpose of this study is to help determine how best to incorporate small amounts of human and digital support into a meditation app. The meditation app used is the Healthy Minds Program (HMP) which provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices.
Detailed description
Participants will be randomly assigned to various support conditions that vary across three binary factors,
1. Coaching session vs no coaching 2. On-demand email support (Yes/No) 3. Microsupport messages (Yes/No)
Participants will be screened for eligibility using a web-based screener that assesses inclusion and exclusion criteria. Eligible participants will receive a study overview and will have the option to go through an online consent process. After giving consent, participant will receive a text message to assess their ability to receive text messages and tab on a link embedded in the text message. Those who failed to go through this process will be screened out.
Participants consented will complete a baseline survey consisting of a series of questionnaires and daily check-in assessment sent to their phone. Only those who successfully complete the baseline survey and the first daily check-in survey will advance in the study. Participants will schedule a meeting with our study staff member after completing the baseline survey and first daily check-in survey. They will be assessed through questionnaires at baseline, weekly during the 4-week intervention period, and at 6-month follow-up. They will also complete daily check-in survey twice a day throughout the intervention.
Interventions
- Other Introductory Coaching Session
Participant is randomized to receive a 30-minute meditation coaching session - Other Introductory Information Session
Participant is randomized to receive a 30-minute information session - Other On-Demand Email Support
email support throughout the 4 week intervention period - Other Microsupport
Text message microsupport throughout the 4 week intervention period
Primary outcome measures
- Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) Score [Time frame: baseline, week 1, week 2, week 3, week 4, 6-month follow up]
- Anxiety Measured from Evening Daily Diary Items [Time frame: Daily through the Intervention Period (up to 4 weeks)]
- Depression Measured from Evening Daily Diary Items [Time frame: Daily through the Intervention Period (up to 4 weeks)]
Secondary outcome measures (12)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Depression [Time frame: baseline, week 1, week 2, week 3, week 4, 6-month follow up]
- PROMIS Toolbox Meaning and Purpose Score [Time frame: baseline, week 1, week 2, week 3, week 4, 6-month follow up]
- NIH Toolbox Loneliness Score [Time frame: baseline, week 1, week 2, week 3, week 4, 6-month follow up]
- Beck's Depression Inventory (BDI) Item 9 Score [Time frame: baseline, week 1, week 2, week 3, week 4, 6-month follow up]
- Five Facet Mindfulness Questionnaire (Awareness subscale) Score [Time frame: baseline, week 1, week 2, week 3, week 4, 6-month follow up]
- Experiences Questionnaire Decentering subscale Score [Time frame: baseline, week 1, week 2, week 3, week 4, 6-month follow up]
- Healthy Minds Index (HM Index) - Awareness Score [Time frame: baseline, week 4, 6-month follow up]
- Healthy Minds Index (HM Index) - Connection Score [Time frame: baseline, week 4, 6-month follow up]
- Healthy Minds Index (HM Index) - Insight Score [Time frame: baseline, week 4, 6-month follow up]
- Healthy Minds Index (HM Index) - Purpose Score [Time frame: baseline, week 4, 6-month follow up]
- Growth Mindset Scale Adapted for Well-being Score [Time frame: baseline, week 4, 6-month follow up]
- Digital Working Alliance Inventory (DWAI) Score [Time frame: week 1, week 2, week 3, week 4]
Eligibility criteria
Inclusion criteria
- Elevated symptoms of depression and/or anxiety (PHQ-9 greater than or equal to 10, GAD-7 greater than or equal to 10)
- Proficiency in English
- Access to a smartphone and internet
- Ability to receive text messages
Exclusion criteria
- Non-US citizen or legal resident (green card holder)
- History of psychosis or mania
- Suicidal ideation or thoughts of self-harm indicated by PHQ9 item 9 and BDI item 9
- Individuals who do not provide the information required for GUID generation
- Previous participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Center for Healthy Minds — Madison
Identifiers
NCT: NCT07278466 · 2025-1444 · Protocol Version 4/2/2026 · EDUC/COUNSELING PSYCH · 1R01MH139512-01