NCT03707197

Brief Summary

The aim of this study is to test the effects of a digital meditation intervention in a sample of UCLA employees who report mild to moderate stress. We will randomize University of California Los Angeles employees to either 8-weeks of a digital meditation intervention (using the commercially available application Headspace) or a waitlist control condition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
943

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2020

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

October 9, 2018

Last Update Submit

November 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reductions in perceived stress as measured by the Perceived Stress Scale

    Changes in the Perceived Stress Scale (range: 1-40; Cohen, Kamarck, \& Mermelstein, 1988). Higher scores indicate greater psychological distress.

    Baseline to post-intervention (8 weeks from baseline)

Secondary Outcomes (2)

  • Reductions in stress-induced eating as measured by the Palatable Eating Motives Scale

    Baseline to post-intervention (8 weeks from baseline)

  • Reductions in reward-based eating as measured by the Reward-based Eating Drive

    Baseline to post-intervention (8 weeks from baseline)

Study Arms (2)

Meditation Group

EXPERIMENTAL

The intervention group will be assigned to a digitally-based meditation intervention (Headspace app- Basic + Stress packs) and asked to use this for at least 10 minutes a day over the course of 8 weeks

Behavioral: Meditation

Wait-list Control Group

NO INTERVENTION

Wait-list control group participants will continue their normal activities and not engage in any form of meditation during the study period

Interventions

MeditationBEHAVIORAL

Ten minutes of meditation per day for 8 weeks using a mobile application

Meditation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have access to a smartphone or computer everyday
  • Are fluent in English
  • Are a University of California, Los Angeles employee
  • Report mild to moderate levels of stress
  • Consent: demonstrate understanding of the study and willingness to participate as evidenced by voluntary informed consent and has received a signed and dated copy of the informed consent
  • Are at least 18 years of age

You may not qualify if:

  • You may not join if you are an experienced meditator or have participated in a formal meditation practice in the last 6 months (defined as once or more per week for a duration of 20 minutes or more at each practice)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

MeSH Terms

Interventions

Meditation

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Janet Tomiyama, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Investigator will be blind to condition throughout data accrual.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomization to either digital meditation condition or waitlist-control condition
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 16, 2018

Study Start

October 15, 2018

Primary Completion

September 11, 2020

Study Completion

September 11, 2020

Last Updated

November 9, 2020

Record last verified: 2020-11

Locations