Human and Digital Support Study

NCT ID: NCT06244043

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-07

Study Completion Date

2024-06-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Participants will not be informed which version of the introductory coaching session they are receiving.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Initial Interventional Coaching Call Plus Email Support

Group Type ACTIVE_COMPARATOR

Initial Coaching Call

Intervention Type 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).

Email Support

Intervention Type OTHER

Email-based support throughout study period

Text Messages

Intervention Type OTHER

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

Initial Interventional Coaching Call No Email Support

Group Type ACTIVE_COMPARATOR

Initial Coaching Call

Intervention Type 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).

Text Messages

Intervention Type OTHER

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

Initial Informational Coaching Call Plus Email Support

Group Type ACTIVE_COMPARATOR

Email Support

Intervention Type OTHER

Email-based support throughout study period

Text Messages

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Text Messages

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type OTHER

Email Support

Email-based support throughout study period

Intervention Type OTHER

Text Messages

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Thrive Foundation

UNKNOWN

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Simon Goldberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A171600

Identifier Type: OTHER

Identifier Source: secondary_id

EDUC/COUNSELING PSYCH

Identifier Type: OTHER

Identifier Source: secondary_id

2023-1379

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Media and Mental Health
NCT07286305 RECRUITING NA