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

Primary Purpose

Psychological Stress, Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress Free Now online program
Group support session
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Psychological Stress focused on measuring Perceived stress, Burnout, Mindfulness, Intent to leave nursing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Stress Free Now with group support

Stress Free Now

Control

Arm Description

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

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.

Randomized participants do not have access to online stress reduction program, Stress Free Now, nor do they attend weekly group support sessions.

Outcomes

Primary Outcome Measures

Burnout
Measured by Maslach Burnout Inventory Human Services Survey

Secondary Outcome Measures

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

Full Information

First Posted
February 15, 2013
Last Updated
May 6, 2022
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01796054
Brief Title
Stress Free Now, a Mind-body Reduction Program for Nurses
Acronym
SFN-Nurses
Official Title
Effectiveness of a Mind-body Stress Reduction Program for Nurses: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress, Anxiety, Depression
Keywords
Perceived stress, Burnout, Mindfulness, Intent to leave nursing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stress Free Now with group support
Arm Type
Experimental
Arm Description
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
Arm Title
Stress Free Now
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Randomized participants do not have access to online stress reduction program, Stress Free Now, nor do they attend weekly group support sessions.
Intervention Type
Behavioral
Intervention Name(s)
Stress Free Now online program
Intervention Description
Stress Free Now is an online stress reduction program. Participants will log into online program, read and practice daily and weekly activities.
Intervention Type
Behavioral
Intervention Name(s)
Group support session
Intervention Description
Participants will meet weekly for group support session to review online lessons and relaxation therapies.
Primary Outcome Measure Information:
Title
Burnout
Description
Measured by Maslach Burnout Inventory Human Services Survey
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Perceived stress
Description
Measured by Perceived Stress Scale
Time Frame
24 weeks
Title
Self-reported BMI
Time Frame
24 weeks
Title
Emotional well-being
Description
Measured by RAND Short-Form (SF)-36
Time Frame
24 weeks
Title
Insomnia
Time Frame
24 weeks
Title
Psychosomatic symptoms
Description
Measured by Psychosomatic Symptoms Checklist
Time Frame
24 weeks
Title
Mindfulness
Description
Measured by Five Factor Mindfulness Questionnaire
Time Frame
24 weeks
Title
Intent to leave nursing
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Bernstein, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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

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