Massed and Spaced HMP App Dosage Study

Psychological Distress Clinical Trial

Official title:

Massed and Spaced Healthy Minds Program App Dosage Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04741529
• Other study ID #: 2020-1454
• Secondary ID: A171600EDUC/COUN
• Status: Completed
• Phase: N/A
• Start date: March 9, 2021
• Est. completion date: May 18, 2021

Study information

• Verified date: June 2021
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: May 18, 2021
• Est. primary completion date: May 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• Loneliness
• Psychological Distress

Intervention

Behavioral:
• Healthy Minds Program app
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.

Locations

Country	Name	City	State
United States	University of Wisconsin - Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who completed the study		2 weeks
Primary	Number of meditation sessions per day using the HMP app		2 weeks
Primary	Number of minutes of meditation practice using the HMP app		2 weeks
Primary	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	2 weeks
Secondary	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.	Baseline and 2 weeks
Secondary	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.	Baseline and 2 weeks
Secondary	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	Baseline and 2 weeks
Secondary	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.	Baseline and 2 weeks
Secondary	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	Baseline and 2 weeks
Secondary	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.	Baseline and 2 weeks
Secondary	Single item loneliness score	"How lonely did you feel today?", range = 1 to 7, lower score is better	Up to 2 weeks
Secondary	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.	Up to 2 weeks
Secondary	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.	Up to 2 weeks
Secondary	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.	2 weeks