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

NCT ID: NCT01796054

Last Updated: 2022-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-08-31

Brief Summary

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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

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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.

Conditions

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Psychological Stress Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Stress Free Now online program

Intervention Type 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

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Stress Free Now online program

Intervention Type BEHAVIORAL

Stress Free Now is an online stress reduction program. Participants will log into online program, read and practice daily and weekly activities.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Group support session

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Linda Libertini

Research Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam Bernstein, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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12-1398

Identifier Type: -

Identifier Source: org_study_id

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