NCT02087891

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

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

May 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

February 26, 2014

Last Update Submit

May 6, 2022

Conditions

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • To see whether a one-hour weekly group at work improves mindfulness.

    Outcome measured using Mindful Attention Awareness Scale (MASS) questionnaire.

    8 week

  • To see whether a one-hour weekly group at work reduces stress.

    Outcome measured using the Perceived Stress Scale (PSS10) questionnaire.

    8 weeks

  • To see whether a one-hour weekly group at work decreases burnout.

    Outcome measured using Maslach Burnout Inventory (MBI) questionnaire.

    8 weeks

  • 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 Outcomes (4)

  • Assess if the program is effective at increasing emotional well-being.

    8 weeks, 16 weeks, and 1 year

  • Assess whether the program leads to an increase in work productivity.

    8 weeks, 16 weeks, and 1 year

  • Assess if the program is effective at increasing vitality.

    8 weeks, 16 weeks, 1 year

  • Assess if the program is effective at increasing emotional role functioning.

    8 weeks, 16 weeks, 1 year

Study Arms (4)

CTL

NO INTERVENTION

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

Web-based stress management (WSM)

EXPERIMENTAL

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)

WSMg1

EXPERIMENTAL

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)Behavioral: Group Support (WSMg1)

WSMg2

EXPERIMENTAL

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)Behavioral: Group Support (WSMg1)Behavioral: Clinical Expert Support (WSMg2)

Interventions

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.

Also known as: Stress Free Now
WSMg1WSMg2Web-based stress management (WSM)

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.

WSMg1WSMg2

A clinical psychologist will replace the non-expert facilitator during 4 group support sessions.

WSMg2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Frontline employee of large corporate call center
  • Internet access

You may not qualify if:

  • Manager or supervisor of large corporate call center

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Links

MeSH Terms

Conditions

Stress, Psychological

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Adam Bernstein, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR
  • Didier Allexandre, PhD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 26, 2014

First Posted

March 14, 2014

Study Start

May 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2012

Last Updated

May 11, 2022

Record last verified: 2022-05

Locations