An interventional study of meditation in Stress, Psychological and Behavioral Symptoms, sponsored by University of California, Irvine. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Treatment
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.
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).
90 studies on the registry are indexed under Behavioral Symptoms; 18 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 84 across 75 interventional studies indexed under Behavioral Symptoms.
Browse Behavioral Symptoms studies →University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
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Exclusion Criteria:
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
Behavioral: meditation
Waitlist control group participants will continue their normal activities and not add any form of meditation during the study period.
10 minute per day, 8 week digital meditation
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
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University of California, Irvine