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

Depression Clinical Trial

— SFN-Nurses  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796054
• Other study ID #: 12-1398
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: August 2014

Study information

• Verified date: May 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Psychological Stress
• Stress, Psychological

Intervention

Behavioral:
• Stress Free Now online program
Stress Free Now is an online stress reduction program. Participants will log into online program, read and practice daily and weekly activities.
• Group support session
Participants will meet weekly for group support session to review online lessons and relaxation therapies.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Burnout	Measured by Maslach Burnout Inventory Human Services Survey	24 weeks
Secondary	Perceived stress	Measured by Perceived Stress Scale	24 weeks
Secondary	Self-reported BMI		24 weeks
Secondary	Emotional well-being	Measured by RAND Short-Form (SF)-36	24 weeks
Secondary	Insomnia		24 weeks
Secondary	Psychosomatic symptoms	Measured by Psychosomatic Symptoms Checklist	24 weeks
Secondary	Mindfulness	Measured by Five Factor Mindfulness Questionnaire	24 weeks
Secondary	Intent to leave nursing		24 weeks