StressNCT03624348
The Impact of 8 Weeks of a Digital Meditation Application on Work Stress
A study testing meditation in people with Stress and Psychological, run by University of California, Irvine at 1 site in United States.
Trial summary
The aim of this study is to test the effects of a digital meditation intervention in a sample University of California, Irvine (UCI) employees who report mild to moderate stress. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Behavioral Symptoms
- What is being tested?
- meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2018to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- You may join if you:
- Have access to a smartphone or computer every day
- Are fluent in English
- Are a UCSF 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California Irvine
Irvine, California, 92697
John F Hunter, MA, 657-229-3138, stressfreeuci@gmail.com
Sarah D Pressman, PhD
About this study
Official title: The Impact of 8 Weeks of a Digital Meditation Application on Stress and Job Strain in a Heterogeneous University Employee Cohort
The aim of this study is to test the effects of a digital meditation intervention in a sample University of California, Irvine (UCI) employees who report mild to moderate stress. UCI employees will be randomized to either 8-weeks of a digital meditation intervention (using the commercially available application Headspace) or a waitlist control condition.
Read the detailed description
The aim of this study is to test the effects of a digital meditation intervention in a sample UCI employees who report moderate to high stress. UCI employees will be randomized to either 8-weeks of a digital meditation intervention (using the commercially available application Headspace) or a waitlist control condition.
Participants assigned to the intervention group will be asked to download and use the Headspace mobile application for at least 10 minutes per day for 8 weeks. All study participants will be asked to fill out short (no longer than 25 minutes) questionnaires at baseline, week 4, week 8 (post intervention), and a 4-month follow up period. Among participants who are randomized to the digital meditation intervention, they will also take part in a 1-year follow up. All activities will take place online (via computer or smartphone).
Prior to randomization, participants will go through an eligibility screening and complete the baseline questionnaire battery. The entirety of the study is digital and there are no in-person assessments. Adherence will be tracked remotely. The goal is to recruit as many as 2000 participants (1000 per condition).
- Conditions
- Stress, Psychological, Behavioral Symptoms
- Being tested
- meditation
- Keywords
- stress, mindfulness, work related stress, health, meditation
- Medical subject headings
- Behavioral Symptoms, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meditationBehavioural
10 minute per day, 8 week digital meditation
| Study group | Role | What they receive |
|---|---|---|
| Meditation Group | Experimental | Participants in the intervention group will assigned to a digitally-based meditation intervention (Headspace app- Basics + Stress packs) and asked to use this for at least 10 minutes a day over the course of 8 weeks Receives: Behavioral: meditation |
| Wait list control group | No intervention | Waitlist control group participants will continue their normal activities and not add any form of meditation during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived stress score, as determined by the total score on the Perceived Stress Scale
The Perceived Stress Scale has a total score scale range of 0 to 40, with higher values indicating more perceived stress
Measured: Baseline to post-intervention, an anticipated average of 8 weeks
Secondary outcomes (5)
Change in job strain, as determined by Siegrist Job Strain Scale
The job strain measure is a comprised of two sub scales, effort (5 items) and reward (11 items), each ranging from 1 to 4. The job strain score is calculated as the ratio of demand to reward, with a higher ratio reflecting more job strain.
Measured: Baseline to post-intervention, an anticipated average of 8 weeks
Change in job overcommitment, as as determined by Siegrist Job Strain Scale
The job overcommitment subscale of the Siegrist Job Strain Scale is comprised of 4 items providing a total score range from 4 to16. A higher total score reflects more job overcommitment.
Measured: Baseline to post-intervention, an anticipated average of 8 weeks
Change in burnout, as determined by the Bergen Burnout Inventory
The Bergen Burnout Inventory is comprised of 9 items, ranging from 1 to 6. The total score range is from 9 to 54 with a higher score reflecting higher burnout.
Measured: Baseline to post-intervention, an anticipated average of 8 weeks
Change in subjective mindfulness, as determined by total score on Mindful Attention Awareness Scale
The Mindful Attention Awareness Scale is a 15-item measure with each item ranging from a score of 1 to 6. To score the scale, we compute the average score across items, with a higher score reflecting higher levels of mindfulness.
Measured: Baseline to post-intervention, an anticipated average of 8 weeks
Change in work engagement, as determined by the Utrecht Work Engagement Scale
The Utrecht Work Engagement scale is comprised of 9 items, with a total score ranging from 0 to 54, with higher scores indicating more work engagement.
Measured: Baseline to post-intervention, an anticipated average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start20 Sep 2018
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to either digital meditation condition or wait-list control.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624348
- Sponsor's protocol ID
- HS#2018-4252
- Status last verified
- Apr 2021
- First submitted
- 7 Aug 2018
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of 8 Weeks of a Digital Meditation Application on Stress and Job Strain in a Heterogeneous University Employee Cohort
- ClinicalTrials.gov ID
- NCT03624348
- Acronym / sponsor ID
- HS#2018-4252
- Conditions
- Stress, Psychological, Behavioral Symptoms
- Keywords
- stress, mindfulness, work related stress, health, meditation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to test the effects of a digital meditation intervention in a sample University of California, Irvine (UCI) employees who report mild to moderate stress. UCI employees will be randomized to either 8-weeks of a digital meditation intervention (using the commercially available application Headspace) or a waitlist control condition.
Detailed description
The aim of this study is to test the effects of a digital meditation intervention in a sample UCI employees who report moderate to high stress. UCI employees will be randomized to either 8-weeks of a digital meditation intervention (using the commercially available application Headspace) or a waitlist control condition.
Participants assigned to the intervention group will be asked to download and use the Headspace mobile application for at least 10 minutes per day for 8 weeks. All study participants will be asked to fill out short (no longer than 25 minutes) questionnaires at baseline, week 4, week 8 (post intervention), and a 4-month follow up period. Among participants who are randomized to the digital meditation intervention, they will also take part in a 1-year follow up. All activities will take place online (via computer or smartphone).
Prior to randomization, participants will go through an eligibility screening and complete the baseline questionnaire battery. The entirety of the study is digital and there are no in-person assessments. Adherence will be tracked remotely. The goal is to recruit as many as 2000 participants (1000 per condition).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomization to either digital meditation condition or wait-list control.
| Arm | Type | Receives |
|---|---|---|
| Meditation Group | Experimental | Behavioral: meditationParticipants in the intervention group will assigned to a digitally-based meditation intervention (Headspace app- Basics + Stress packs) and asked to use this for at least 10 minutes a day over the course of 8 weeks |
| Wait list control group | No intervention | –Waitlist control group participants will continue their normal activities and not add any form of meditation during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have access to a smartphone or computer every day
- Are fluent in English
- Are a UCSF 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| meditation10 minute per day, 8 week digital meditation | Behavioural | Meditation Group |
Primary outcome
Change in perceived stress score, as determined by the total score on the Perceived Stress Scale
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
The Perceived Stress Scale has a total score scale range of 0 to 40, with higher values indicating more perceived stress
5 secondary outcomes
Change in job strain, as determined by Siegrist Job Strain Scale
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
Change in job overcommitment, as as determined by Siegrist Job Strain Scale
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
Change in burnout, as determined by the Bergen Burnout Inventory
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
Change in subjective mindfulness, as determined by total score on Mindful Attention Awareness Scale
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
Change in work engagement, as determined by the Utrecht Work Engagement Scale
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing meditation in people with Stress and Psychological, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived stress score, as determined by the total score on the Perceived Stress Scale (time frame: Baseline to post-intervention, an anticipated average of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.