Clinical trial NCT06244043: Human and Digital Support Study
Official title: Human and Digital Support Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: meditation
app
HMP
Healthy Minds Program
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Thrive Foundation
First posted: 2024-02-06
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Study completion rate
timeFrame: Baseline to 4 weeks (post-intervention)
measure: Daily diary completion rate
timeFrame: Baseline to 4 weeks (post-intervention)
measure: Acceptability of Intervention Score
timeFrame: 4 weeks (post-intervention)
measure: Modified System Usability Scale Score
timeFrame: 4 weeks (post-intervention)
Secondary outcomes:
Other outcomes:
measure: Attitudes Towards Psychological Online Interventions Score
timeFrame: 4 weeks (post-intervention)
measure: Determinants of Meditation Practice Inventory Score
timeFrame: baseline (pre-intervention)
measure: Patient Health Questionnaire - 9 (PHQ-9) Score
timeFrame: baseline (pre-intervention), 4 weeks (post-intervention)
measure: PROMIS Meaning and Purpose Score
timeFrame: baseline (pre-intervention), 4 weeks (post-intervention)
measure: Digital Working Alliance Inventory (D-WAI) Score
timeFrame: 4 weeks (post-intervention)
measure: Five Facet Mindfulness Questionnaire (FFMQ): Awareness Score
timeFrame: baseline (pre-intervention), 4 weeks (post-intervention)
measure: General Anxiety Disorder -7 (GAD-7) Score
timeFrame: screening, 4 weeks (post-intervention)
measure: Mindfulness Adherence Questionnaire: Minutes of meditation per week
timeFrame: 4 weeks (post-intervention)
measure: Mindfulness Adherence Questionnaire Score
timeFrame: 4 weeks (post-intervention)
measure: Healthy Minds Index Score
timeFrame: baseline (pre-intervention), 4 weeks (post-intervention)
measure: NIH Toolbox: Loneliness Score
timeFrame: baseline (pre-intervention), 4 weeks (post-intervention)
measure: Growth Mindset Scale for Well-Being Score
timeFrame: baseline (pre-intervention), 4 weeks (post-intervention)
measure: Experiences Questionnaire Decentering Score
timeFrame: baseline (pre-intervention), 4 weeks (post-intervention)
measure: Daily Diary Assessment Question Scores
timeFrame: daily from baseline to post-test (week 4)
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Simon Goldberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: