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Meditation Group for Psychological Distress

Phase 3
Waitlist Available
Led By Matthew J Zawadzki, PhD
Research Sponsored by University of California, Merced
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline physical activity at 8 weeks
Awards & highlights

Study Summary

The aim of this study is to investigate the effects of the app-based mindfulness intervention (i.e., the commercially available application Headspace) on overall physical and psychological health. Secondly, this study examines potential mindfulness mechanisms that may be driving these effects (i.e., decentering, attention regulation, acceptance, self-compassion, reactivity, exposure). This study will randomize UC Merced employees to 8-weeks of either a digital mindfulness intervention (Headspace) or a waitlist control condition. Participants assigned to the intervention group will be asked to download and use the Headspace mobile application for 10 minutes per day for 8 weeks. They will be asked to fill out questionnaires at baseline, week 4, week 8 (post intervention), 4-month, and 12-month follow up period (20-30 minutes each time). In addition, participants will be asked to complete surveys on their phone as a part of everyday life assessments (4 days per week during baseline, 2 weeks, 5 weeks, 8 weeks, up to 5-10 minutes a day). Participants will also wear a fitness watch, Fitbit, to assess their activity, sleep, and heart rate data. For the everyday life assessment part, participants will be asked to participate in one of our 60 minutes orientation sessions where you will receive training on using the mobile app and receive a fitness watch that will be collected upon the completion of the study.

Eligible Conditions
  • Psychological Distress
  • Stress

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline resting heart rate at 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline resting heart rate at 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
10-Item Measure of Stress Perceptions
Secondary outcome measures
1-Item Measure of Leisure Physical Activity
12-Item Subjective Mental and Physical Well-Being Ratings
15-Item Measure of Mindfulness - a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Meditation GroupExperimental Treatment1 Intervention
Headspace application: Participants in the intervention group will use a digitally-based mindfulness intervention Headspace app (Basics + Stress packs) will be used for 10 minutes a day over the course of 8 weeks.
Group II: No intervention, control groupActive Control1 Intervention
Control group participants will continue their normal activities and not add any form of meditation during the study period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Meditation
2021
Completed Phase 3
~2740

Find a Location

Who is running the clinical trial?

University of California, MercedLead Sponsor
17 Previous Clinical Trials
5,921 Total Patients Enrolled
Healthy Campus Network, University of California, Office of the PresidentUNKNOWN
Headspace Meditation LimitedIndustry Sponsor
4 Previous Clinical Trials
1,328 Total Patients Enrolled

Frequently Asked Questions

~30 spots leftby Apr 2025