Human and Digital Support Study

NCT06244043 | Completed

• 3 other identifiers: 2023-1379A171600EDUC/COUNSELING PSYCH
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Anxiety

Keywords

meditation; app; HMP; Healthy Minds Program

Outcome Measures

Primary Outcomes (4)

• Study completion rate

  Percentage of participants completing pre- and post-test measures

  Baseline to 4 weeks (post-intervention)

• Daily diary completion rate

  Percentage of daily assessments completed

  Baseline to 4 weeks (post-intervention)

• Acceptability of Intervention Score

  12-item survey scored from 1 - 5 where higher scores indicate more acceptability.

  4 weeks (post-intervention)

• Modified System Usability Scale Score

  10-item survey scored from 1-5 where higher scores indicate more usability.

  4 weeks (post-intervention)

Other Outcomes (14)

• Attitudes Towards Psychological Online Interventions Score

  4 weeks (post-intervention)

• Determinants of Meditation Practice Inventory Score

  baseline (pre-intervention)

• Patient Health Questionnaire - 9 (PHQ-9) Score

  baseline (pre-intervention), 4 weeks (post-intervention)

Study Arms (4)

Initial Interventional Coaching Call Plus Email Support

ACTIVE COMPARATOR

Other: Initial Coaching Call; Other: Email Support; Other: Text Messages

Initial Interventional Coaching Call No Email Support

ACTIVE COMPARATOR

Other: Initial Coaching Call; Other: Text Messages

Initial Informational Coaching Call Plus Email Support

ACTIVE COMPARATOR

Other: Email Support; Other: Text Messages

Initial Informational Coaching Call No Email Support

ACTIVE COMPARATOR

Other: Text Messages

Interventions

Initial Coaching Call OTHER

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).

Initial Interventional Coaching Call No Email Support; Initial Interventional Coaching Call Plus Email Support

Email Support OTHER

Email-based support throughout study period

Initial Informational Coaching Call Plus Email Support; Initial Interventional Coaching Call Plus Email Support

Text Messages OTHER

All participants with receive text messages encouraging them to engage in the practices taught in the app.

Initial Informational Coaching Call No Email Support; Initial Informational Coaching Call Plus Email Support; Initial Interventional Coaching Call No Email Support; Initial Interventional Coaching Call Plus Email Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current suicidal or self-harm ideation (PHQ-9 item 9 \> 0)
• Current or past psychotic disorder
• Current of past bipolar disorder

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Thrive Foundation: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Alzheimer Disease

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Officials

• Simon Goldberg, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be informed which version of the introductory coaching session they are receiving.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: March 7, 2024
• Primary Completion: June 2, 2024
• Study Completion: June 2, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)