NCT05605041

Brief Summary

Headspace, a smartphone application that provides guided meditation, mindfulness and sleep exercises, will be used as the intervention in improving sleep, anxiety, depression and burnout in all participating individuals selected from the University of Arizona College of Medicine-Tucson residents and fellows.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Status
withdrawn

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

June 1, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

August 3, 2025

Status Verified

July 1, 2022

Enrollment Period

Same day

First QC Date

June 1, 2022

Last Update Submit

July 30, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • The Effects on Burnout

    The intervention group will be asked to fill out the Maslachs Burnout Inventory (MBI) survey prior to intervention starting, 30 days after start of intervention and then again at 90 days after start of intervention). the MBI is a measure of three independent constructs - emotional exhaustion, depersonalization, and personal accomplishment. Lower scores will indicate less of an impact on those constructs. Higher scores indicate a stronger impact on those constructs. A score for emotional exhaustion includes anything \<27, a low score is 0-18. For Depersonalisation a high score is anything \>10 and a low score is 0-5. For Personal accomplishment a high score is 0-33 and low score is anything \>40

    30-90 days

  • The Effects on Sleep

    The intervention group will be asked to fill out the Epworth Sleepiness Scale survey prior to intervention starting, 30 days after start of intervention and then again at 90 days after start of intervention). The scores will be analyzed to determine impact on sleep. Lower scores indicate a normal range of sleepiness, higher scores (18-24) will be indicative of severe sleepiness. Lower scores of 0-10 will be indicative of a normal range of sleepiness in healthy adults.

    30-90 days

  • The effects on Anxiety and Depression

    The intervention group will be asked to fill out the GAD-7 (Generalized Anxiety Disorder) questionnaire prior to intervention starting, 30 days after start of intervention and then again at 90 days after start of intervention. The scores will be analyzed to determine impact on anxiety and depression. Lower versus higher scores will be proportional to how much anxiety and depression that person is facing. A score of 0-4 is indicative of minimal anxiety and a score of \> 15 is indicative of severe anxiety.

    30-90 days

Study Arms (2)

Did Not Use Headspace

NO INTERVENTION

Those that did not use headspace during the time the study is conducted

Did Use Headspace

EXPERIMENTAL

Those that were randomized into the group and used Headspace at least once during the study period

Device: Headspace

Interventions

HeadspaceDEVICE

Headspace is an app that allows users to practice mindfulness through guided meditation

Did Use Headspace

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • University of Arizona resident or fellow

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Burnout, PsychologicalAnxiety Disorders

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorMental Disorders
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2022

First Posted

November 4, 2022

Study Start

December 1, 2022

Primary Completion

December 1, 2022

Study Completion

February 1, 2023

Last Updated

August 3, 2025

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share