Human and Digital Support Study

Depression Clinical Trial

Official title:

Human and Digital Support Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06244043
• Other study ID #: 2023-1379
• Secondary ID: A171600EDUC/COUN
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Depression

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)