Stress Free Now, a Mind-body Reduction Program for Nurses

Not Applicable

Completed

• Conditions: Psychological Stress; Anxiety; Depression

• Registration Number: NCT01796054
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-15
• Study First Submitted QC: 2013-02-19
• Study First Posted: 2013-02-21
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• be at least 18 years of age
• work as a full-time or part-time nurse at Cleveland Clinic
• have regular internet and email access and be willing and able to attend group support sessions
• work at least one weekday during the week in order to attend orientation and/or group support sessions

Exclusion Criteria

• participating in another stress reduction research study
• pregnant, lactating, or planning to be pregnant in the next 6 months
• hospitalized for depression in past 12 months
• vacation time away from work for more than 1 week during the first 2 months of the study
• current diagnosis of schizophrenia, other psychotic or bipolar disorder
• other medial, psychiatric, or behavioral limitations that may interfere with study participation or the ability to follow the intervention protocol
• unwilling or uninterested in participating in group sessions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Burnout	24 weeks	Measured by Maslach Burnout Inventory Human Services Survey

Secondary Outcome Measures

Name	Time	Method
Emotional well-being	24 weeks	Measured by RAND Short-Form (SF)-36
Insomnia	24 weeks
Mindfulness	24 weeks	Measured by Five Factor Mindfulness Questionnaire
Intent to leave nursing	24 weeks
Perceived stress	24 weeks	Measured by Perceived Stress Scale
Self-reported BMI	24 weeks
Psychosomatic symptoms	24 weeks	Measured by Psychosomatic Symptoms Checklist

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States