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Stress Free Now in a Corporate Call Center (SFN)

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-based Stress Management Program (WSM)
Group Support (WSMg1)
Clinical Expert Support (WSMg2)
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Frontline employee of large corporate call center
  • Internet access

Exclusion Criteria:

  • Manager or supervisor of large corporate call center

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

CTL

Web-based stress management (WSM)

WSMg1

WSMg2

Arm Description

Wait-list control, no intervention. Intervention offered after week 16 and outcomes are collected.

Subjects randomized to this group will receive access to the WSM program to complete on their own time.

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.

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.

Outcomes

Primary Outcome Measures

Assess whether an 8-week mindfulness stress reduction online program is effective in improving mindfulness.
Outcome measured using Mindful Attention Awareness Scale (MAAS) questionnaire.
Assess whether an 8-week mindfulness stress reduction online program is effective in reducing stress mindfulness.
Outcome measured using the Perceived Stress Scale (PSS10) questionnaire.
Assess whether an 8-week mindfulness stress reduction online program is effective in decreasing burnout mindfulness.
Outcome measured using the Maslach Burnout Inventory (MBI).
To see whether a one-hour weekly group at work enhances amount of meditation practice.
Outcome measured by self-reported average amount of weekly meditation practice.
To see whether a one-hour weekly group at work improves mindfulness.
Outcome measured using Mindful Attention Awareness Scale (MASS) questionnaire.
To see whether a one-hour weekly group at work reduces stress.
Outcome measured using the Perceived Stress Scale (PSS10) questionnaire.
To see whether a one-hour weekly group at work decreases burnout.
Outcome measured using Maslach Burnout Inventory (MBI) questionnaire.
To see whether a one-hour weekly group at work enhances engagement.
Engagement assessed by measuring number of weeks participants actively accessed the intervention website.

Secondary Outcome Measures

Assess if the program is effective at increasing emotional well-being.
Outcome measured using emotional well-being subscale of the RAND Corporation's Medical Outcomes Study Short Form-36 (SF36).
Assess whether the program leads to an increase in work productivity.
Productivity assessed using the call center composite measure of productivity computed monthly for each call service associate.
Assess if the program is effective at increasing vitality.
Outcome measured using vitality subscale of the RAND Corporation's Medical Outcomes Study Short Form-36 (SF36).
Assess if the program is effective at increasing emotional role functioning.
Outcome measured using emotional role functioning subscale of the RAND Corporation's Medical Outcomes Study Short Form-36 (SF36).

Full Information

First Posted
February 26, 2014
Last Updated
May 6, 2022
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02087891
Brief Title
Stress Free Now in a Corporate Call Center
Acronym
SFN
Official Title
Stress Free Now in a Corporate Call Center
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CTL
Arm Type
No Intervention
Arm Description
Wait-list control, no intervention. Intervention offered after week 16 and outcomes are collected.
Arm Title
Web-based stress management (WSM)
Arm Type
Experimental
Arm Description
Subjects randomized to this group will receive access to the WSM program to complete on their own time.
Arm Title
WSMg1
Arm Type
Experimental
Arm Description
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.
Arm Title
WSMg2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Web-based Stress Management Program (WSM)
Other Intervention Name(s)
Stress Free Now
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group Support (WSMg1)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Clinical Expert Support (WSMg2)
Intervention Description
A clinical psychologist will replace the non-expert facilitator during 4 group support sessions.
Primary Outcome Measure Information:
Title
Assess whether an 8-week mindfulness stress reduction online program is effective in improving mindfulness.
Description
Outcome measured using Mindful Attention Awareness Scale (MAAS) questionnaire.
Time Frame
8 weeks
Title
Assess whether an 8-week mindfulness stress reduction online program is effective in reducing stress mindfulness.
Description
Outcome measured using the Perceived Stress Scale (PSS10) questionnaire.
Time Frame
8 weeks
Title
Assess whether an 8-week mindfulness stress reduction online program is effective in decreasing burnout mindfulness.
Description
Outcome measured using the Maslach Burnout Inventory (MBI).
Time Frame
8 weeks
Title
To see whether a one-hour weekly group at work enhances amount of meditation practice.
Description
Outcome measured by self-reported average amount of weekly meditation practice.
Time Frame
8 weeks
Title
To see whether a one-hour weekly group at work improves mindfulness.
Description
Outcome measured using Mindful Attention Awareness Scale (MASS) questionnaire.
Time Frame
8 week
Title
To see whether a one-hour weekly group at work reduces stress.
Description
Outcome measured using the Perceived Stress Scale (PSS10) questionnaire.
Time Frame
8 weeks
Title
To see whether a one-hour weekly group at work decreases burnout.
Description
Outcome measured using Maslach Burnout Inventory (MBI) questionnaire.
Time Frame
8 weeks
Title
To see whether a one-hour weekly group at work enhances engagement.
Description
Engagement assessed by measuring number of weeks participants actively accessed the intervention website.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Assess if the program is effective at increasing emotional well-being.
Description
Outcome measured using emotional well-being subscale of the RAND Corporation's Medical Outcomes Study Short Form-36 (SF36).
Time Frame
8 weeks, 16 weeks, and 1 year
Title
Assess whether the program leads to an increase in work productivity.
Description
Productivity assessed using the call center composite measure of productivity computed monthly for each call service associate.
Time Frame
8 weeks, 16 weeks, and 1 year
Title
Assess if the program is effective at increasing vitality.
Description
Outcome measured using vitality subscale of the RAND Corporation's Medical Outcomes Study Short Form-36 (SF36).
Time Frame
8 weeks, 16 weeks, 1 year
Title
Assess if the program is effective at increasing emotional role functioning.
Description
Outcome measured using emotional role functioning subscale of the RAND Corporation's Medical Outcomes Study Short Form-36 (SF36).
Time Frame
8 weeks, 16 weeks, 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Frontline employee of large corporate call center Internet access Exclusion Criteria: Manager or supervisor of large corporate call center
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Bernstein, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Didier Allexandre, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.clevelandclinicwellness.com/relax
Description
Stress Free Now (web-based stress management program)

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Stress Free Now in a Corporate Call Center

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