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

May 6, 2022 updated by: Linda Libertini, The Cleveland Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Stress Free Now with group support
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
Stress Free Now is an online stress reduction program. Participants will log into online program, read and practice daily and weekly activities.
Behavioral: Group support session
Participants will meet weekly for group support session to review online lessons and relaxation therapies.
EXPERIMENTAL: Stress Free Now
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
Stress Free Now is an online stress reduction program. Participants will log into online program, read and practice daily and weekly activities.
NO_INTERVENTION: Control
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
Time Frame: 24 weeks
Measured by Maslach Burnout Inventory Human Services Survey
24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

February 15, 2013

First Submitted That Met QC Criteria

February 19, 2013

First Posted (ESTIMATE)

February 21, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-1398

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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