- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02087891
Stress Free Now in a Corporate Call Center (SFN)
May 6, 2022 updated by: Linda Libertini, The Cleveland Clinic
Psychosocial stress increases the risk for a multitude of diseases, including obesity, hypertension, and cardiovascular disease.
Stress may also result in increased utilization of health care services.
In the workplace, stress leads to emotional exhaustion, job dissatisfaction, lower productivity and impaired performance.
Stress management programs and those based on mindfulness meditation have gained popularity in recent years.
The purpose of this study is to evaluate the feasibility of an 8-week web-based mindfulness stress reduction program and its effectiveness in reducing work related stress and improving well-being in a large corporate call center.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
161
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
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Frontline employee of large corporate call center
- Internet access
Exclusion Criteria:
- Manager or supervisor of large corporate call center
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: CTL
Wait-list control, no intervention.
Intervention offered after week 16 and outcomes are collected.
|
|
|
Experimental: Web-based stress management (WSM)
Subjects randomized to this group will receive access to the WSM program to complete on their own time.
|
The intervention, developed by the Cleveland Clinic, is an 8-week online, interactive, educational program based on mindfulness meditation.
Briefly, each week subjects are introduced to the (1) weekly audio introduction to the mindfulness theme or particular meditation technique of the week, (2) weekly audio meditation techniques for relaxation, (3) daily articles providing scientific evidence and merits of meditation, and (4) bi-weekly email reminders.
The introductory talks and meditation exercises were also provided on compact discs (CD) in mp3 format.
Other Names:
|
|
Experimental: WSMg1
Subjects randomized to this group will receive access to WSM with group support.
They will meet once per week for 1 hour.
Meeting will be led by one of their peers who is a non-expert facilitator.
|
The intervention, developed by the Cleveland Clinic, is an 8-week online, interactive, educational program based on mindfulness meditation.
Briefly, each week subjects are introduced to the (1) weekly audio introduction to the mindfulness theme or particular meditation technique of the week, (2) weekly audio meditation techniques for relaxation, (3) daily articles providing scientific evidence and merits of meditation, and (4) bi-weekly email reminders.
The introductory talks and meditation exercises were also provided on compact discs (CD) in mp3 format.
Other Names:
Subjects will meet once per week for 1 hour during the 8-week duration and practice 2-minutes of deep breathing exercises, listen to 10-minutes audio recording of the weekly lesson and practice 20-30 minutes guided meditation exercise.
The remainder of the time will be used to foster sharing experiences and answering specific questions related to the weekly lesson.
|
|
Experimental: WSMg2
Subjects randomized to this group will receive access to WSM and group support and clinical expert support.
They will attend 4 weekly support groups led by a peer non-expert facilitator and 4 weekly support groups led by a clinical psychologist.
|
The intervention, developed by the Cleveland Clinic, is an 8-week online, interactive, educational program based on mindfulness meditation.
Briefly, each week subjects are introduced to the (1) weekly audio introduction to the mindfulness theme or particular meditation technique of the week, (2) weekly audio meditation techniques for relaxation, (3) daily articles providing scientific evidence and merits of meditation, and (4) bi-weekly email reminders.
The introductory talks and meditation exercises were also provided on compact discs (CD) in mp3 format.
Other Names:
Subjects will meet once per week for 1 hour during the 8-week duration and practice 2-minutes of deep breathing exercises, listen to 10-minutes audio recording of the weekly lesson and practice 20-30 minutes guided meditation exercise.
The remainder of the time will be used to foster sharing experiences and answering specific questions related to the weekly lesson.
A clinical psychologist will replace the non-expert facilitator during 4 group support sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess whether an 8-week mindfulness stress reduction online program is effective in improving mindfulness.
Time Frame: 8 weeks
|
Outcome measured using Mindful Attention Awareness Scale (MAAS) questionnaire.
|
8 weeks
|
|
Assess whether an 8-week mindfulness stress reduction online program is effective in reducing stress mindfulness.
Time Frame: 8 weeks
|
Outcome measured using the Perceived Stress Scale (PSS10) questionnaire.
|
8 weeks
|
|
Assess whether an 8-week mindfulness stress reduction online program is effective in decreasing burnout mindfulness.
Time Frame: 8 weeks
|
Outcome measured using the Maslach Burnout Inventory (MBI).
|
8 weeks
|
|
To see whether a one-hour weekly group at work enhances amount of meditation practice.
Time Frame: 8 weeks
|
Outcome measured by self-reported average amount of weekly meditation practice.
|
8 weeks
|
|
To see whether a one-hour weekly group at work improves mindfulness.
Time Frame: 8 week
|
Outcome measured using Mindful Attention Awareness Scale (MASS) questionnaire.
|
8 week
|
|
To see whether a one-hour weekly group at work reduces stress.
Time Frame: 8 weeks
|
Outcome measured using the Perceived Stress Scale (PSS10) questionnaire.
|
8 weeks
|
|
To see whether a one-hour weekly group at work decreases burnout.
Time Frame: 8 weeks
|
Outcome measured using Maslach Burnout Inventory (MBI) questionnaire.
|
8 weeks
|
|
To see whether a one-hour weekly group at work enhances engagement.
Time Frame: 8 weeks
|
Engagement assessed by measuring number of weeks participants actively accessed the intervention website.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess if the program is effective at increasing emotional well-being.
Time Frame: 8 weeks, 16 weeks, and 1 year
|
Outcome measured using emotional well-being subscale of the RAND Corporation's Medical Outcomes Study Short Form-36 (SF36).
|
8 weeks, 16 weeks, and 1 year
|
|
Assess whether the program leads to an increase in work productivity.
Time Frame: 8 weeks, 16 weeks, and 1 year
|
Productivity assessed using the call center composite measure of productivity computed monthly for each call service associate.
|
8 weeks, 16 weeks, and 1 year
|
|
Assess if the program is effective at increasing vitality.
Time Frame: 8 weeks, 16 weeks, 1 year
|
Outcome measured using vitality subscale of the RAND Corporation's Medical Outcomes Study Short Form-36 (SF36).
|
8 weeks, 16 weeks, 1 year
|
|
Assess if the program is effective at increasing emotional role functioning.
Time Frame: 8 weeks, 16 weeks, 1 year
|
Outcome measured using emotional role functioning subscale of the RAND Corporation's Medical Outcomes Study Short Form-36 (SF36).
|
8 weeks, 16 weeks, 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Didier Allexandre, PhD, The Cleveland Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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
May 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
February 26, 2014
First Submitted That Met QC Criteria
March 12, 2014
First Posted (Estimate)
March 14, 2014
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB# 11-254
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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