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

Study Overview
=================
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.

Official Title
-----------------
Effectiveness of a Mind-body Stress Reduction Program for Nurses: A Randomized Controlled Study

Conditions
-----------------
Anxiety, Psychological Stress, Depression

Intervention / Treatment
-----------------
* Behavioral: Stress Free Now online program
* Behavioral: Group support session


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress Free Now with group support<br>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<br>* Stress Free Now is an online stress reduction program. Participants will log into online program, read and practice daily and weekly activities.<br>Behavioral: Group support session<br>* Participants will meet weekly for group support session to review online lessons and relaxation therapies.<br>|
| Experimental: Stress Free Now<br>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<br>* Stress Free Now is an online stress reduction program. Participants will log into online program, read and practice daily and weekly activities.<br>|
| No Intervention: Control<br>Randomized participants do not have access to online stress reduction program, Stress Free Now, nor do they attend weekly group support sessions. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burnout | Measured by Maslach Burnout Inventory Human Services Survey | 24 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perceived stress, Burnout, Mindfulness, Intent to leave nursing