StressPhase 3NCT03652168
Stress Free UC Merced: The Effect of 8 Weeks of Mindfulness App Headspace on Stress in a Sample of University Employees
A Phase 3 study testing Meditation in people with Stress and Psychological Distress, run by University of California, Merced at 1 site in United States.
Trial 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. 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 Distress
- 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
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 31 Aug 2020
- Phase
- Phase 3
- 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
- Have access to a smartphone or computer with internet every day
- Are fluent in English
- Are a UC Merced employee
- 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
- Individuals may not join if they are experienced meditators or have participated in a sitting meditation practice more than twice a week (for 10 minutes or greater) over the last three months.
Trial locations and contacts
1 site in 1 country.
Larisa Gavrilova, BA contact
United States1 site
University of California, Merced
Merced, California, 95343
About this study
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.
Read the detailed description
Stress at work has shown to be an important health risk for employees. It is associated with poor mental and physical health including anxiety, depression, sleep disturbances, gastrointestinal problems, type 2 diabetes, and cardiovascular disease. Work stress also has major implications for employers as evidence suggests that high levels of work stress predict employee burnout, turnover intent, absenteeism, and poor job performance.
Mindfulness and its positive effects on a variety of outcomes, including stress reduction, have been documented in many studies. The most common definition of mindfulness is as the state of being attentive to and aware of the present moment with an attitude of openness and acceptance. Several mechanisms by which mindfulness exerts its positive effects have been proposed in the literature including cultivating the attitude of non-judgement and acceptance, ability to observe one's experiences objectively without reacting to them, and ability to be more patient and kind toward oneself. Recent evidence suggests that teaching mindfulness in the workplace not only reduces stress but also improve psychological well-being.
With advances in technology, technology-based delivery of many interventions has become popular. App-based treatments for improving psychological health are becoming increasingly important due to high accessibility and cost-effectiveness of smartphone technology. Despite a great number of app-based interventions, there has been little research evaluating their efficacy. Support for the use of smartphone app-based mindfulness interventions comes from a few small studies that found these interventions to produce benefits comparable to traditional delivery methods. While app-based interventions offer a convenient alternative to traditional delivery methods as well as promising initial empirical evidence, more research is needed in order to further evaluate and promote these interventions.
The proposed study has several goals. The first goal is to investigate the effects of the app-based mindfulness intervention on overall physical and psychological health (e.g., perceived stress, mindfulness, sleep quality, self-reported health, anxiety symptoms). The second goal is to examine the effect of the intervention on a variety of work-related outcomes (e.g., work stress, job satisfaction, work-related burnout). Further, the study will examine potential mindfulness mechanisms that may drive these effects (e.g., acceptance, reactivity, decentering).
- Conditions
- Stress, Psychological Distress
- Being tested
- Meditation
- Keywords
- stress, health, mindfulness, employees
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
10 minute a day, 8 week digital meditation
| Study group | Role | What they receive |
|---|---|---|
| Meditation Group | Experimental | 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. Receives: Behavioral: Meditation |
| No intervention, control group | No intervention | 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.
10-Item Measure of Stress Perceptions
Self-reported stress perceptions over the over the past month. Each item is scored using a 0 (never) and 4 (very often) scale. Items are averaged together such that scores can range from 0 to 40; higher scores indicate higher perceived stress. Total score ranging from 0-13 would be considered low stress. Score ranging from 14-26 would be considered moderate stress. Score ranging from 27-40 would be considered high perceived stress.
Measured: Change from Baseline Stress Perceptions at 12 months
Secondary outcomes (9)
9-Item Measure of Symptoms of Depression and Distress
Self-reported symptoms of depression and distress over the last two weeks. Answers range from 0 (not at all) to 4 (nearly every day). Scores are added across columns to get a total score. Scores can range from 0 to 36, the lowest score of 1- 4 indicate minimal depression; higher scores 20-27 indicating severe depression.
Measured: Change from Baseline Depression at 12 months
7-Item Measure of Symptoms of Anxiety
Self-reported symptoms of anxiety over the last two weeks. Answers range from 0 (not at all) to 4 (nearly every day). Scores are added across columns to get a total score. Scores can range from 0 to 28 and scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Measured: Change from Baseline Anxiety at 12 months
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
Self-reported mindfulness ratings participants report on average each day. Answers are given on a 1 (almost always) to 6 (almost never) scale. Total score is calculated by computing a mean of the 15 items. Scores can range from 15 to 90 with higher scores reflect higher levels of dispositional mindfulness.
Measured: Change from Baseline Mindfulness at 12 months
19-Item Measure of Sleep Quality
Self-reported measure of sleep quality over the last month. The self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a total score of "0" indicates no difficulty and "21" indicating severe difficulties in all areas.
Measured: Change from Baseline Sleep Quality at 8 weeks
1-Item Measure of Leisure Physical Activity
Self-reported measure of physical activity performed on average during leisure activity over the past month. Item is scored on a 0 (no physical activity) to 4 (vigorous activity at least 3 times a week) scale
Measured: Change from Baseline Physical Activity at 8 weeks
Resting Heart Rate
The Fitbit watch worn during the intervention will assess resting heart rate levels each day.
Measured: Change from Baseline Resting Heart Rate at 8 weeks
12-Item Subjective Mental and Physical Well-Being Ratings
Self-reported measure of views about mental and physical well-being on average. The items are scored on a 0 to 100 and averaged, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Measured: Change from Baseline Self-reported health at 8 weeks
3-Item Job Satisfaction Measure
Self-reported assessment of average levels of job satisfaction. Items are scored on a 1 (Disagree very much) to 6 (Agree very much) with an average total score across items ranging from 3 to 18.
Measured: Change from Job Satisfaction at 12 months
5-Item Work-Family Balance Measure of emotional, behavioral and time demands of both paid work and family (if relevant) or personal duties.
Self-reported measure of work-family balance on average. Items are scores on a 1 (strongly disagree) to 7 (strongly agree) scale. Items are averaged together with the total score ranging from 5 to 35.
Measured: Change from Baseline Work-family Balance at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Merced
- Sponsor type
- University, hospital or other
- Collaborators
- The University of California's Healthy Campus Network, Headspace Meditation Limited
- Responsible party
- Principal investigator, Matthew Zawadzki, University of California, Merced
- Investigators
- Matthew J Zawadzki, PhD, Principal investigator, UC Merced
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652168
- Sponsor's protocol ID
- UCM2018-9
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bishop, S. R., Lau, M., Shapiro, S., Carlson, L., Anderson, N. D., Carmody, J., ... & Devins, G. (2004). Mindfulness: A proposed operational definition. Clinical psychology: Science and practice, 11(3), 230-241.
Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
PubMed 12703651Ganster, D. C., & Rosen, C. C. (2013). Work stress and employee health: A multidisciplinary review. Journal of Management, 39(5), 1085-1122.
Goedhard, R. G., & Goedhard, W. J. (2005, June). Work ability and perceived work stress. In International Congress Series(Vol. 1280, pp. 79-83). Elsevier.
Jamieson SD, Tuckey MR. Mindfulness interventions in the workplace: A critique of the current state of the literature. J Occup Health Psychol. 2017 Apr;22(2):180-193. doi: 10.1037/ocp0000048. Epub 2016 Sep 19.
PubMed 27643606Fairburn CG, Patel V. The impact of digital technology on psychological treatments and their dissemination. Behav Res Ther. 2017 Jan;88:19-25. doi: 10.1016/j.brat.2016.08.012.
PubMed 28110672Howells, A., Ivtzan, I., & Eiroa-Orosa, F. J. (2016). Putting the 'app'in happiness: a randomised controlled trial of a smartphone-based mindfulness intervention to enhance wellbeing. Journal of Happiness Studies, 17(1), 163-185.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Free UC Merced: The Effect of 8 Weeks of Mindfulness App Headspace on Stress in a Sample of University Employees
- ClinicalTrials.gov ID
- NCT03652168
- Acronym / sponsor ID
- UCM2018-9
- Conditions
- Stress, Psychological Distress
- Keywords
- stress, health, mindfulness, employees
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, MercedUniversity, hospital or other
- Collaborators
- The University of California's Healthy Campus Network, Headspace Meditation Limited
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 29 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 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.
Detailed description
Stress at work has shown to be an important health risk for employees. It is associated with poor mental and physical health including anxiety, depression, sleep disturbances, gastrointestinal problems, type 2 diabetes, and cardiovascular disease. Work stress also has major implications for employers as evidence suggests that high levels of work stress predict employee burnout, turnover intent, absenteeism, and poor job performance.
Mindfulness and its positive effects on a variety of outcomes, including stress reduction, have been documented in many studies. The most common definition of mindfulness is as the state of being attentive to and aware of the present moment with an attitude of openness and acceptance. Several mechanisms by which mindfulness exerts its positive effects have been proposed in the literature including cultivating the attitude of non-judgement and acceptance, ability to observe one's experiences objectively without reacting to them, and ability to be more patient and kind toward oneself. Recent evidence suggests that teaching mindfulness in the workplace not only reduces stress but also improve psychological well-being.
With advances in technology, technology-based delivery of many interventions has become popular. App-based treatments for improving psychological health are becoming increasingly important due to high accessibility and cost-effectiveness of smartphone technology. Despite a great number of app-based interventions, there has been little research evaluating their efficacy. Support for the use of smartphone app-based mindfulness interventions comes from a few small studies that found these interventions to produce benefits comparable to traditional delivery methods. While app-based interventions offer a convenient alternative to traditional delivery methods as well as promising initial empirical evidence, more research is needed in order to further evaluate and promote these interventions.
The proposed study has several goals. The first goal is to investigate the effects of the app-based mindfulness intervention on overall physical and psychological health (e.g., perceived stress, mindfulness, sleep quality, self-reported health, anxiety symptoms). The second goal is to examine the effect of the intervention on a variety of work-related outcomes (e.g., work stress, job satisfaction, work-related burnout). Further, the study will examine potential mindfulness mechanisms that may drive these effects (e.g., acceptance, reactivity, decentering).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation Group | Experimental | Behavioral: MeditationHeadspace 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. |
| No intervention, control group | No intervention | –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 (5 listed)
- Have access to a smartphone or computer with internet every day
- Are fluent in English
- Are a UC Merced employee
- 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
Key exclusion criteria (1 listed)
- Individuals may not join if they are experienced meditators or have participated in a sitting meditation practice more than twice a week (for 10 minutes or greater) over the last three months.
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 a day, 8 week digital meditation | Behavioural | Meditation Group |
Primary outcome
10-Item Measure of Stress Perceptions
Time frame: Change from Baseline Stress Perceptions at 12 months
Self-reported stress perceptions over the over the past month. Each item is scored using a 0 (never) and 4 (very often) scale. Items are averaged together such that scores can range from 0 to 40; higher scores indicate higher perceived stress. Total score ranging from 0-13 would be considered low stress. Score ranging from 14-26 would be considered moderate stress. Score ranging from 27-40 would be considered high perceived stress.
9 secondary outcomes
9-Item Measure of Symptoms of Depression and Distress
Time frame: Change from Baseline Depression at 12 months
7-Item Measure of Symptoms of Anxiety
Time frame: Change from Baseline Anxiety at 12 months
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
Time frame: Change from Baseline Mindfulness at 12 months
19-Item Measure of Sleep Quality
Time frame: Change from Baseline Sleep Quality at 8 weeks
1-Item Measure of Leisure Physical Activity
Time frame: Change from Baseline Physical Activity at 8 weeks
Resting Heart Rate
Time frame: Change from Baseline Resting Heart Rate at 8 weeks
12-Item Subjective Mental and Physical Well-Being Ratings
Time frame: Change from Baseline Self-reported health at 8 weeks
3-Item Job Satisfaction Measure
Time frame: Change from Job Satisfaction at 12 months
5-Item Work-Family Balance Measure of emotional, behavioral and time demands of both paid work and family (if relevant) or personal duties.
Time frame: Change from Baseline Work-family Balance at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- BackgroundBishop, S. R., Lau, M., Shapiro, S., Carlson, L., Anderson, N. D., Carmody, J., ... & Devins, G. (2004). Mindfulness: A proposed operational definition. Clinical psychology: Science and practice, 11(3), 230-241.
- Background: PubMed 12703651Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
- BackgroundGanster, D. C., & Rosen, C. C. (2013). Work stress and employee health: A multidisciplinary review. Journal of Management, 39(5), 1085-1122.
- BackgroundGoedhard, R. G., & Goedhard, W. J. (2005, June). Work ability and perceived work stress. In International Congress Series(Vol. 1280, pp. 79-83). Elsevier.
- Background: PubMed 27643606Jamieson SD, Tuckey MR. Mindfulness interventions in the workplace: A critique of the current state of the literature. J Occup Health Psychol. 2017 Apr;22(2):180-193. doi: 10.1037/ocp0000048. Epub 2016 Sep 19.
- Background: PubMed 28110672Fairburn CG, Patel V. The impact of digital technology on psychological treatments and their dissemination. Behav Res Ther. 2017 Jan;88:19-25. doi: 10.1016/j.brat.2016.08.012.
- BackgroundHowells, A., Ivtzan, I., & Eiroa-Orosa, F. J. (2016). Putting the 'app'in happiness: a randomised controlled trial of a smartphone-based mindfulness intervention to enhance wellbeing. Journal of Happiness Studies, 17(1), 163-185.
- 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.
Larisa Gavrilova, BA contact
Matthew J Zawadzki, PhD principal investigator
UC Merced
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meditation in people with Stress and Psychological Distress, run by University of California, Merced 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 5 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 29 Aug 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Matthew J Zawadzki, PhD ((209) 228-4787, mzawadzki@ucmerced.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-Item Measure of Stress Perceptions (time frame: Change from Baseline Stress Perceptions at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03652168, which also lists 7 linked publications.
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 29 Aug 2018.