An interventional study of Stress Free Now online program and Group support session in Psychological Stress, Anxiety and Depression, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-11.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Other
Mindful meditation sessions have been associated with an improvement in mindfulness, perceived stress, psychological well-being, anxiety, hostility, and depression. Meditation has been associated with a decrease in autonomic sympathetic activity, heart rate, oxygen consumption and energy expenditure. Randomized controlled trials of online mindfulness and relaxation programs have been studied in patients with conditions such as irritable bowel syndrome, headache, depression, fibromyalgia, and insomnia. Nurses may benefit from such programs given levels of job stress. This study will determine whether an online stress reduction program that incorporates meditation with and without concomitant group support reduces burnout among nurses, including emotional exhaustion and depersonalization. The proposed research study will utilize Stress Free Now, an online stress reduction program developed by Cleveland Clinic Wellness Institute.
This is a randomized, controlled, single-center research study of an online intervention with peer group support to reduce stress in nurses. All participants will be assigned to the intervention or control groups by random number allocation. The duration of the intervention is 6 weeks; follow-up is at 6 and 24 weeks; the duration of the study is 6 months (24 weeks). Total individual participant time commitment will depend on particular intervention or control group assignment. Both intervention and control groups will be requested to complete a set of questionnaires at weeks 0, 6, and 24. The questionnaires will take an estimated 45 minutes to complete.
806 studies on the registry are indexed under Stress, Psychological; 131 are open to participants now.
This study's enrollment of 360 is above the median of 84 across 651 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
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Exclusion Criteria:
Randomized participants have access to online stress reduction program, Stress Free Now. Participants will log in to online program, read daily lessons and practice therapeutic exercises. They will also attend weekly group support session during 6-week program
Behavioral: Stress Free Now online program · Behavioral: Group support session
Randomized participants have access to online stress reduction program, Stress Free Now, for 6 weeks. Participants will log into online program, read daily lessons and practice therapeutic exercises.
Behavioral: Stress Free Now online program
Randomized participants do not have access to online stress reduction program, Stress Free Now, nor do they attend weekly group support sessions.
Stress Free Now is an online stress reduction program. Participants will log into online program, read and practice daily and weekly activities.
Participants will meet weekly for group support session to review online lessons and relaxation therapies.
Burnout
Measured by Maslach Burnout Inventory Human Services Survey
Time frame: 24 weeks
Perceived stress
Measured by Perceived Stress Scale
Time frame: 24 weeks
Self-reported BMI
Time frame: 24 weeks
Emotional well-being
Measured by RAND Short-Form (SF)-36
Time frame: 24 weeks
Insomnia
Time frame: 24 weeks
Psychosomatic symptoms
Measured by Psychosomatic Symptoms Checklist
Time frame: 24 weeks
Mindfulness
Measured by Five Factor Mindfulness Questionnaire
Time frame: 24 weeks
Intent to leave nursing
Time frame: 24 weeks
The record gives a start of Feb 2013, a primary completion of Aug 2014 and a completion of Aug 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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