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Massed and Spaced HMP App Dosage Study

Primary Purpose

Depression, Anxiety, Psychological Distress, Loneliness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Minds Program app
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • Undergraduate at UW-Madison
  • Access to a smartphone or device capable of downloading HMP app
  • PROMIS Depression or PROMIS Anxiety ≥55

Exclusion Criteria:

  • Meditation retreat experience
  • Regular meditation practice (i.e., weekly practice for >1 year OR daily practice within previous 6 months)
  • Previous practice under the instruction of a meditation teacher, other than in the context of an introductory course
  • PROMIS Depression ≥70

Sites / Locations

  • University of Wisconsin - Madison

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Massed condition

Spaced condition

Arm Description

Participant will be asked to use the HMP app for 20 minutes per day in one 20-minute meditation session.

Participant will be asked to use the HMP app for 20 minutes per day in two 10-minute meditation sessions.

Outcomes

Primary Outcome Measures

Percentage of participants who completed the study
Number of meditation sessions per day using the HMP app
Number of minutes of meditation practice using the HMP app
System Usability Scale score
System usability scale is (SUS) is a 10-item Likert scale questionnaire that provides information on the ease of use (or lack thereof) of websites, software, hardware, mobile devices, and other technological applications. Higher SUS score correlates to better usability of an app, total score range = 0 to 100

Secondary Outcome Measures

Change in the PROMIS (Patient-Reported Outcomes Measurement Information System) Depression score
Psychological distress computed as composite of 4-item PROMIS Depression measures. Scores range from 4 to 20 with higher scores representing worse symptoms.
Change in the PROMIS Anxiety score
Psychological distress computed as composite of 4-item PROMIS Anxiety measures. Scores range from 4 to 20 with higher scores representing worse symptoms.
Change in NIH Toolbox Loneliness score
NIH toolbox loneliness measures the perceptions that one is alone, lonely, or socially isolated from others. It is a 5-item scale. Total score range = 5 to 25, lower score is better
Change in Self-Compassion Short Form score
This 12-item measure assesses participant's self-compassion ability, total score range = 12 to 60, higher scores correlate to more self-compassion.
Change in Fear of Missing Out scale score
Fear of missing out is a 10 item scale. Total score range = 10 to 50, lower score is better
Change in Acceptance and Action Questionnaire - II score
Acceptance and Action Questionnaire- II measures psychological flexibility Experiential avoidance, total score range = 7 to 49. Higher total scores mean less flexibility, while lower total scores mean more flexibility. Lower score is better.
Single item loneliness score
"How lonely did you feel today?", range = 1 to 7, lower score is better
Highest loading PROMIS Depression and PROMIS Anxiety items score
Composite of highest loading PROMIS items modified to reference "today," z-transformed to have mean of 0 and standard deviation of 1, lower score is better.
Single item informal meditation practice
Single item informal meditation practice measure, "As you reflect on today, to what extent did you apply these practices?" Scores range from 0 to 100. A higher score is better.
Digital Working Alliance Inventory score
The Digital Working Alliance Inventory measures the therapeutic relationship between participant and HMP app. Total score range = 6 to 42, higher score is better.

Full Information

First Posted
January 29, 2021
Last Updated
June 10, 2021
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT04741529
Brief Title
Massed and Spaced HMP App Dosage Study
Official Title
Massed and Spaced Healthy Minds Program App Dosage Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
May 18, 2021 (Actual)
Study Completion Date
May 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a randomized controlled trial (RCT) of 2 weeks of the Healthy Minds Program (HMP) app Connection module in undergraduate students of a large, midwestern state university in the United States during the spring of 2021. Participants will be recruited via email and/or flyers and will first complete an online screen. Eligible participants will complete baseline measures prior to attending an introductory session via web conferencing. During this session, participants will be randomly assigned to condition. Participants in both conditions will be asked to use the HMP app for 20 minutes per either, either split over two 10-minute session (Spaced condition) or in one 20-minute session (Massed condition). Participants will complete daily survey measures during the study and post-test measures after 2 weeks of intervention. This study is primarily designed to assess feasibility and acceptability of 2 weeks of Connection training and assignment to dosage condition. Study team will investigate self-reported informal practice on the daily diary measure, measures of psychological distress (composite of depression, anxiety) and loneliness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Psychological Distress, Loneliness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
351 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Massed condition
Arm Type
Experimental
Arm Description
Participant will be asked to use the HMP app for 20 minutes per day in one 20-minute meditation session.
Arm Title
Spaced condition
Arm Type
Experimental
Arm Description
Participant will be asked to use the HMP app for 20 minutes per day in two 10-minute meditation sessions.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Minds Program app
Intervention Description
The HMP app was developed by Healthy Minds Innovations at the UW Center for Healthy Minds, and is based on the work of Drs. Richard Davidson and Cortland Dahl. HMP is designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of high-quality guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). HMP has >100 guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. Participants in this study will receive 2 weeks of training in the Connection module of HMP.
Primary Outcome Measure Information:
Title
Percentage of participants who completed the study
Time Frame
2 weeks
Title
Number of meditation sessions per day using the HMP app
Time Frame
2 weeks
Title
Number of minutes of meditation practice using the HMP app
Time Frame
2 weeks
Title
System Usability Scale score
Description
System usability scale is (SUS) is a 10-item Likert scale questionnaire that provides information on the ease of use (or lack thereof) of websites, software, hardware, mobile devices, and other technological applications. Higher SUS score correlates to better usability of an app, total score range = 0 to 100
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Change in the PROMIS (Patient-Reported Outcomes Measurement Information System) Depression score
Description
Psychological distress computed as composite of 4-item PROMIS Depression measures. Scores range from 4 to 20 with higher scores representing worse symptoms.
Time Frame
Baseline and 2 weeks
Title
Change in the PROMIS Anxiety score
Description
Psychological distress computed as composite of 4-item PROMIS Anxiety measures. Scores range from 4 to 20 with higher scores representing worse symptoms.
Time Frame
Baseline and 2 weeks
Title
Change in NIH Toolbox Loneliness score
Description
NIH toolbox loneliness measures the perceptions that one is alone, lonely, or socially isolated from others. It is a 5-item scale. Total score range = 5 to 25, lower score is better
Time Frame
Baseline and 2 weeks
Title
Change in Self-Compassion Short Form score
Description
This 12-item measure assesses participant's self-compassion ability, total score range = 12 to 60, higher scores correlate to more self-compassion.
Time Frame
Baseline and 2 weeks
Title
Change in Fear of Missing Out scale score
Description
Fear of missing out is a 10 item scale. Total score range = 10 to 50, lower score is better
Time Frame
Baseline and 2 weeks
Title
Change in Acceptance and Action Questionnaire - II score
Description
Acceptance and Action Questionnaire- II measures psychological flexibility Experiential avoidance, total score range = 7 to 49. Higher total scores mean less flexibility, while lower total scores mean more flexibility. Lower score is better.
Time Frame
Baseline and 2 weeks
Title
Single item loneliness score
Description
"How lonely did you feel today?", range = 1 to 7, lower score is better
Time Frame
Up to 2 weeks
Title
Highest loading PROMIS Depression and PROMIS Anxiety items score
Description
Composite of highest loading PROMIS items modified to reference "today," z-transformed to have mean of 0 and standard deviation of 1, lower score is better.
Time Frame
Up to 2 weeks
Title
Single item informal meditation practice
Description
Single item informal meditation practice measure, "As you reflect on today, to what extent did you apply these practices?" Scores range from 0 to 100. A higher score is better.
Time Frame
Up to 2 weeks
Title
Digital Working Alliance Inventory score
Description
The Digital Working Alliance Inventory measures the therapeutic relationship between participant and HMP app. Total score range = 6 to 42, higher score is better.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Undergraduate at UW-Madison Access to a smartphone or device capable of downloading HMP app PROMIS Depression or PROMIS Anxiety ≥55 Exclusion Criteria: Meditation retreat experience Regular meditation practice (i.e., weekly practice for >1 year OR daily practice within previous 6 months) Previous practice under the instruction of a meditation teacher, other than in the context of an introductory course PROMIS Depression ≥70
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon B Goldberg, PhD
Organizational Affiliation
UW-Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be de-identified and listed in public data registries (i.e., osf) based on the publication of preregistered study hypotheses on a manuscript by manuscript basis.
IPD Sharing Time Frame
Data may be shared following analysis and publication or upon request.

Learn more about this trial

Massed and Spaced HMP App Dosage Study

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