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Completed

NCT Number: NCT01796054

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

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.

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Key information

Conditions

Psychological Stress Anxiety Anxiety Disorders Behavior Behavioral Symptoms Burnout, Psychological Depression Mental Disorders Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stress Free Now online program

Behavioral

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

Behavioral

Participants will meet weekly for group support session to review online lessons and relaxation therapies.

Primary outcomes

  1. Burnout

    Time frame: 24 weeks

    Measured by Maslach Burnout Inventory Human Services Survey

Secondary outcomes

  1. Perceived stress

    Time frame: 24 weeks

    Measured by Perceived Stress Scale

  2. Self-reported BMI

    Time frame: 24 weeks

  3. Emotional well-being

    Time frame: 24 weeks

    Measured by RAND Short-Form (SF)-36

  4. Insomnia

    Time frame: 24 weeks

  5. Psychosomatic symptoms

    Time frame: 24 weeks

    Measured by Psychosomatic Symptoms Checklist

  6. Mindfulness

    Time frame: 24 weeks

    Measured by Five Factor Mindfulness Questionnaire

  7. Intent to leave nursing

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Acronym: SFN-Nurses

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 21, 2013
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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