Stress, PsychologicalSFNNCT02087891
Stress Free Now in a Corporate Call Center
A study testing Web-based Stress Management Program (WSM), Group Support (WSMg1) and Clinical Expert Support (WSMg2) in people with Stress, Psychological, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Web-based Stress Management Program (WSM), Group Support (WSMg1) and Clinical Expert Support (WSMg2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Frontline employee of large corporate call center
- Internet access
Who cannot join
- Manager or supervisor of large corporate call center
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stress, Psychological
- Being tested
- Web-based Stress Management Program (WSM), Group Support (WSMg1), Clinical Expert Support (WSMg2)
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based Stress Management Program (WSM)Behavioural
Also called Stress Free Now
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)Behavioural
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)Behavioural
A clinical psychologist will replace the non-expert facilitator during 4 group support sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Web-based Stress Management Program (WSM); Behavioral: Group Support (WSMg1); Behavioral: Clinical Expert Support (WSMg2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess whether an 8-week mindfulness stress reduction online program is effective in improving mindfulness.
Outcome measured using Mindful Attention Awareness Scale (MAAS) questionnaire.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 8 weeks
To see whether a one-hour weekly group at work improves mindfulness.
Outcome measured using Mindful Attention Awareness Scale (MASS) questionnaire.
Measured: 8 week
To see whether a one-hour weekly group at work reduces stress.
Outcome measured using the Perceived Stress Scale (PSS10) questionnaire.
Measured: 8 weeks
To see whether a one-hour weekly group at work decreases burnout.
Outcome measured using Maslach Burnout Inventory (MBI) questionnaire.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (4)
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).
Measured: 8 weeks, 16 weeks, and 1 year
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.
Measured: 8 weeks, 16 weeks, and 1 year
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).
Measured: 8 weeks, 16 weeks, 1 year
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).
Measured: 8 weeks, 16 weeks, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Libertini, The Cleveland Clinic
- Investigators
- Adam Bernstein, MD, Principal investigator, The Cleveland ClinicDidier Allexandre, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087891
- Sponsor's protocol ID
- IRB# 11-254
- Acronym
- SFN
- Status last verified
- May 2022
- First submitted
- 26 Feb 2014
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Free Now in a Corporate Call Center
- ClinicalTrials.gov ID
- NCT02087891
- Acronym / sponsor ID
- SFN / IRB# 11-254
- Conditions
- Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CTL | No intervention | –Wait-list control, no intervention. Intervention offered after week 16 and outcomes are collected. |
| Web-based stress management (WSM) | Experimental | Behavioral: Web-based Stress Management Program (WSM)Subjects randomized to this group will receive access to the WSM program to complete on their own time. |
| WSMg1 | Experimental | Behavioral: Web-based Stress Management Program (WSM), Behavioral: Group Support (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. |
| WSMg2 | Experimental | Behavioral: Web-based Stress Management Program (WSM), Behavioral: Group Support (WSMg1), Behavioral: Clinical Expert Support (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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Frontline employee of large corporate call center
- Internet access
Key exclusion criteria (1 listed)
- Manager or supervisor of large corporate call center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based Stress Management Program (WSM)Also: Stress Free NowThe 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. | Behavioural | WSMg1, WSMg2, Web-based stress management (WSM) |
| 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. | Behavioural | WSMg1, WSMg2 |
| Clinical Expert Support (WSMg2)A clinical psychologist will replace the non-expert facilitator during 4 group support sessions. | Behavioural | WSMg2 |
Primary outcome
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.
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.
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).
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.
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.
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.
To see whether a one-hour weekly group at work decreases burnout.
Time frame: 8 weeks
Outcome measured using Maslach Burnout Inventory (MBI) questionnaire.
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.
4 secondary outcomes
Assess if the program is effective at increasing emotional well-being.
Time frame: 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
Assess if the program is effective at increasing vitality.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Stress Free Now (web-based stress management program)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Bernstein, MD principal investigator
The Cleveland Clinic
Didier Allexandre, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based Stress Management Program (WSM), Group Support (WSMg1) and Clinical Expert Support (WSMg2) in people with Stress, Psychological, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess whether an 8-week mindfulness stress reduction online program is effective in improving mindfulness. (time frame: 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.