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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06244043
Other study ID # 2023-1379
Secondary ID A171600EDUC/COUN
Status Recruiting
Phase N/A
First received
Last updated
Start date March 7, 2024
Est. completion date August 2024

Study information

Verified date March 2024
Source University of Wisconsin, Madison
Contact Zishan Jiwani
Phone 608-265-8986
Email zjiwani@wisc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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. 32 participants will be enrolled and can expect to be on study for up to 4 weeks.


Description:

The overall purpose of this study is to help determine the feasibility and acceptability of incorporating small amounts of human and digital support into a meditation app. Ultimately, the investigators hope this work will help to develop digital tools that can reduce symptoms of depression and/or anxiety. The meditation app of interest is the Healthy Minds Program (HMP). The HMP app provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices. Participants will be randomly assigned to receive or not receive an initial coaching call with a team member. Participants will also be randomly assigned to receive or not receive access to email-based support. All participants with receive text messages encouraging them to engage in the practices taught in the app. Participants will complete a set of questionnaires at baseline and post-test (following the 4-week intervention period). Questionnaires and items will be selected from the set of questionnaires included in this application. The average length of time to complete questionnaires will be within 15 to 30 minutes. Participants will also receive short daily surveys.


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults (age =18) who have recently downloaded the HMP app - Elevated symptoms of depression and/or anxiety - Patient Health Questionnaire - 9 (PHQ-9) = 5 - General Anxiety Disorder - 7 (GAD-7) = 5 Exclusion Criteria: - Current suicidal or self-harm ideation (PHQ-9 item 9 > 0) - Current or past psychotic disorder - Current of past bipolar disorder

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Initial Coaching Call
Participant will receive initial coaching call with a team member. This coaching call will either be interventional (i.e., include content intended to prompt their adherence and benefit from the HMP app) or informational (i.e., include content intended to control for the time and attention of attending a coaching session, but not intended to provide specific benefits).
Email Support
Email-based support throughout study period
Text Messages
All participants with receive text messages encouraging them to engage in the practices taught in the app.

Locations

Country Name City State
United States University of Wisconsin Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison Thrive Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Attitudes Towards Psychological Online Interventions Score 16-item survey scored from 1 - 5 where higher scores indicate more positive attitude in each of 4 domains: skepticism, confidence, threat, anonymity. 4 weeks (post-intervention)
Other Determinants of Meditation Practice Inventory Score 12-item survey scored from 1 - 5 where lower scores indicate lower perceived barriers to meditation practice in each of 4 domains; benefit, knowledge, pragmatic, cultural. baseline (pre-intervention)
Other Patient Health Questionnaire - 9 (PHQ-9) Score 9-item survey scored from 0-27 where higher scores indicate increased depression. baseline (pre-intervention), 4 weeks (post-intervention)
Other PROMIS Meaning and Purpose Score Computer adaptive survey scored from 1-5 where higher scores indicate higher sense of meaning and purpose. baseline (pre-intervention), 4 weeks (post-intervention)
Other Digital Working Alliance Inventory (D-WAI) Score 6-item survey scored from 1-7 where higher scores indicate increased trust in the app in each of three domains: goals, tasks, bond. 4 weeks (post-intervention)
Other Five Facet Mindfulness Questionnaire (FFMQ): Awareness Score 8-item survey scored from 1-5 where higher scores indicate lower levels of awareness. baseline (pre-intervention), 4 weeks (post-intervention)
Other General Anxiety Disorder -7 (GAD-7) Score 7-item survey scored from 0-21 where higher scores indicate increased anxiety. screening, 4 weeks (post-intervention)
Other Mindfulness Adherence Questionnaire: Minutes of meditation per week Minutes of meditation practice completed per week 4 weeks (post-intervention)
Other Mindfulness Adherence Questionnaire Score 10-item survey scored from 0-6 where higher scores indicate higher quality meditation practice in two domains: formal practice, informal practice. 4 weeks (post-intervention)
Other Healthy Minds Index Score 17-item survey scored from 0-4 where higher scores indicate healthier attitude in each of 4 domains: awareness, connection, insight, purpose. baseline (pre-intervention), 4 weeks (post-intervention)
Other NIH Toolbox: Loneliness Score 5-item survey scored from 1-5 where higher scores indicate increased loneliness. baseline (pre-intervention), 4 weeks (post-intervention)
Other Growth Mindset Scale for Well-Being Score 3-item survey scored from 1-6 where higher score lower growth mindset. baseline (pre-intervention), 4 weeks (post-intervention)
Other Experiences Questionnaire Decentering Score 11-item survey scored from 1-5 where higher scores indicate higher levels of decentering. baseline (pre-intervention), 4 weeks (post-intervention)
Other Daily Diary Assessment Question Scores 9-items administered in the morning scored from 1 (not at all) to 5 (very much) for domain: mindfulness, decentering, connection, purpose, depression, anxiety, stress, rumination, motivation.
11-items administered in the evening scored from 1 (not at all) to 5 (very much) for domain: mindfulness, decentering, connection, purpose, depression, anxiety, happy event, stressor exposure item, rumination, informal practice item, formal practice item.
daily from baseline to post-test (week 4)
Primary Study completion rate Percentage of participants completing pre- and post-test measures Baseline to 4 weeks (post-intervention)
Primary Daily diary completion rate Percentage of daily assessments completed Baseline to 4 weeks (post-intervention)
Primary Acceptability of Intervention Score 12-item survey scored from 1 - 5 where higher scores indicate more acceptability. 4 weeks (post-intervention)
Primary Modified System Usability Scale Score 10-item survey scored from 1-5 where higher scores indicate more usability. 4 weeks (post-intervention)
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