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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02087891
Other study ID # IRB# 11-254
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2011
Est. completion date September 2012

Study information

Verified date May 2022
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 161
Est. completion date September 2012
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Frontline employee of large corporate call center - Internet access Exclusion Criteria: - Manager or supervisor of large corporate call center

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
Clinical Expert Support (WSMg2)
A clinical psychologist will replace the non-expert facilitator during 4 group support sessions.

Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assess whether an 8-week mindfulness stress reduction online program is effective in improving mindfulness. Outcome measured using Mindful Attention Awareness Scale (MAAS) questionnaire. 8 weeks
Primary 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. 8 weeks
Primary Assess whether an 8-week mindfulness stress reduction online program is effective in decreasing burnout mindfulness. Outcome measured using the Maslach Burnout Inventory (MBI). 8 weeks
Primary 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. 8 weeks
Primary To see whether a one-hour weekly group at work improves mindfulness. Outcome measured using Mindful Attention Awareness Scale (MASS) questionnaire. 8 week
Primary To see whether a one-hour weekly group at work reduces stress. Outcome measured using the Perceived Stress Scale (PSS10) questionnaire. 8 weeks
Primary To see whether a one-hour weekly group at work decreases burnout. Outcome measured using Maslach Burnout Inventory (MBI) questionnaire. 8 weeks
Primary 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. 8 weeks
Secondary 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). 8 weeks, 16 weeks, and 1 year
Secondary 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. 8 weeks, 16 weeks, and 1 year
Secondary 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). 8 weeks, 16 weeks, 1 year
Secondary 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). 8 weeks, 16 weeks, 1 year
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