Clinical trial NCT01796054: Stress Free Now, a Mind-body Reduction Program for Nurses
Official title: Effectiveness of a Mind-body Stress Reduction Program for Nurses: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Anxiety
Depression
Keywords: Perceived stress
Burnout
Mindfulness
Intent to leave nursing
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2013-02-21
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Burnout
timeFrame: 24 weeks
Secondary outcomes:
measure: Perceived stress
timeFrame: 24 weeks
measure: Self-reported BMI
timeFrame: 24 weeks
measure: Emotional well-being
timeFrame: 24 weeks
measure: Insomnia
timeFrame: 24 weeks
measure: Psychosomatic symptoms
timeFrame: 24 weeks
measure: Mindfulness
timeFrame: 24 weeks
measure: Intent to leave nursing
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Adam Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
References: