Human and Digital Support Study

University of Wisconsin (UW)

Status: Completed

Conditions: Depression; Anxiety

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06244043

2023-1379

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 4 patient groups

Initial Interventional Coaching Call Plus Email Support

Active Comparator group

Treatment:

Other: Initial Coaching Call

Other: Text Messages

Other: Email Support

Initial Interventional Coaching Call No Email Support

Active Comparator group

Treatment:

Other: Initial Coaching Call

Other: Text Messages

Initial Informational Coaching Call Plus Email Support

Active Comparator group

Treatment:

Other: Text Messages

Other: Email Support

Initial Informational Coaching Call No Email Support

Active Comparator group

Treatment:

Other: Text Messages