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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Web-based Stress Management Program (WSM)
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:
  • Stress Free Now
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.
Behavioral: Web-based Stress Management Program (WSM)
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:
  • Stress Free Now
Behavioral: Group Support (WSMg1)
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.
Behavioral: Web-based Stress Management Program (WSM)
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:
  • Stress Free Now
Behavioral: Group Support (WSMg1)
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.
Behavioral: Clinical Expert Support (WSMg2)
A clinical psychologist will replace the non-expert facilitator during 4 group support sessions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Cleveland Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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