Massed and Spaced HMP App Dosage Study
- Conditions
- LonelinessPsychological DistressDepression, Anxiety
- Interventions
- Behavioral: Healthy Minds Program app
- Registration Number
- NCT04741529
- Lead Sponsor
- University of Wisconsin, Madison
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 351
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Massed condition Healthy Minds Program app Participant will be asked to use the HMP app for 20 minutes per day in one 20-minute meditation session. Spaced condition Healthy Minds Program app Participant will be asked to use the HMP app for 20 minutes per day in two 10-minute meditation sessions.
- Primary Outcome Measures
Name Time Method Percentage of participants who completed the study 2 weeks Number of meditation sessions per day using the HMP app 2 weeks Number of minutes of meditation practice using the HMP app 2 weeks System Usability Scale score 2 weeks 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
Name Time Method Highest loading PROMIS Depression and PROMIS Anxiety items score Up to 2 weeks 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.
Change in Acceptance and Action Questionnaire - II score Baseline and 2 weeks 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.
Change in the PROMIS (Patient-Reported Outcomes Measurement Information System) Depression score Baseline and 2 weeks 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 NIH Toolbox Loneliness score Baseline and 2 weeks 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
Single item loneliness score Up to 2 weeks "How lonely did you feel today?", range = 1 to 7, lower score is better
Single item informal meditation practice Up to 2 weeks 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.
Change in the PROMIS Anxiety score Baseline and 2 weeks 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 Fear of Missing Out scale score Baseline and 2 weeks Fear of missing out is a 10 item scale. Total score range = 10 to 50, lower score is better
Digital Working Alliance Inventory score 2 weeks The Digital Working Alliance Inventory measures the therapeutic relationship between participant and HMP app. Total score range = 6 to 42, higher score is better.
Change in Self-Compassion Short Form score Baseline and 2 weeks This 12-item measure assesses participant's self-compassion ability, total score range = 12 to 60, higher scores correlate to more self-compassion.
Trial Locations
- Locations (1)
University of Wisconsin - Madison
🇺🇸Madison, Wisconsin, United States