NCT01796054

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 21, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

February 15, 2013

Last Update Submit

May 6, 2022

Conditions

Psychological StressAnxietyDepression

Keywords

Perceived stressBurnoutMindfulnessIntent to leave nursing

Outcome Measures

Primary Outcomes (1)

  • Burnout

    Measured by Maslach Burnout Inventory Human Services Survey

    24 weeks

Secondary Outcomes (7)

  • Perceived stress

    24 weeks

  • Self-reported BMI

    24 weeks

  • Emotional well-being

    24 weeks

  • Insomnia

    24 weeks

  • Psychosomatic symptoms

    24 weeks

  • +2 more secondary outcomes

Study Arms (3)

Stress Free Now with group support

EXPERIMENTAL

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 programBehavioral: Group support session

Stress Free Now

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Stress Free Now online programBEHAVIORAL

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

Stress Free NowStress Free Now with group support
Group support sessionBEHAVIORAL

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

Stress Free Now with group support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Stress, PsychologicalAnxiety DisordersDepressionBurnout, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Adam Bernstein, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator

Study Record Dates

First Submitted

February 15, 2013

First Posted

February 21, 2013

Study Start

February 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

May 11, 2022

Record last verified: 2022-05

Locations

US(1)