- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02729987
Increasing Engagement With Online Stress Management Interventions
Increasing Engagement With and Effectiveness of an Online CBT Based Stress Management Intervention for Employees Through the Use of an Online Facilitated Bulletin Board: Design of a Pilot Randomized Controlled Trial
Study Overview
Detailed Description
The aim of the pilot study is to identify and address some of the challenges of delivering online psychological interventions in the workplace. There is clear research evidence for the delivery of online psychological interventions within clinical settings (e.g. Andersson & Cuijpers, 2009), but this evidence does not translate to online interventions delivered in work settings (e.g. Geraedts, Kleiboer, Twisk, Wiezer, van Mechelen, & Cuijpers, 2014). Evidence suggests that one of the barriers to the efficacy of online interventions may be the low level of engagement and adherence (Cavanagh & Millings, 2013). This study aims to address this by asking the question: "How can we increase engagement with and adherence to an online intervention delivered in the workplace?"
The pilot study is a three-arm RCT comparing a minimal guided online Cognitive Behaviour Therapy (CBT) based stress management intervention (WorkGuru) delivered with and without an online facilitated bulletin board, to a waiting list control. Both active conditions will have access to an online programme with minimal support from a coach. The discussion group condition will also have access to a facilitated online bulletin board. Up to 90 employees from UK based organisations will be recruited to the study.
Inclusion criteria will include age 18 or over, elevated levels of stress (defined as 1SD above the mean norm on the PSS-10 scale), access to a computer or tablet, and the Internet. The primary outcome measure will be engagement, as defined by the number of logins to the site; secondary outcome measures will include further measures of engagement (the number of pages visited, the number of modules completed and self-report engagement) and measures of effectiveness (psychological distress and subjective wellbeing). Possible moderators will include measures of intervention quality (satisfaction, acceptability, credibility, system usability), time pressure, goal conflict, level of distress at baseline, and job autonomy. Measures will be taken at baseline, 2 weeks (credibility and expectancy measures only), 9 weeks (completion of intervention) and 16 weeks (follow-up). Analyses will be conducted on intention to treat and per protocol principles. Data will be collected electronically using Qualtrics survey software.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hampshire
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Brockenhurst, Hampshire, United Kingdom, SO42 7RA
- WorkGuru
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18 or over
- Employed by a participating organisation, ≥ 20 on the Perceived Stress Scale
- Access to a computer/table and the internet
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Minimum Support Group (MSG)
Intervention group with 8 week access to the online stress management programme with minimal support from a coach (WorkGuru).
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A multi-modal stress management intervention accessed over 8 weeks, incorporates CBT, positive psychology and Mindfulness.
Delivered via the internet.
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Experimental: Discussion Group
Intervention group with 8 week access to the online stress management programme with minimal support from a coach, plus access to an online facilitated messaging board (WorkGuru).
|
A multi-modal stress management intervention accessed over 8 weeks, incorporates CBT, positive psychology and Mindfulness.
Delivered via the internet.
|
No Intervention: Waiting List Control (WLC)
Control group with access to the intervention after 16 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of log-in to the site
Time Frame: 9 weeks
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number of times participants log in to the website
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9 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of modules completed
Time Frame: 9 weeks
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number of modules completed
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9 weeks
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Number of pages visited
Time Frame: 9 weeks
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number of pages visited
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9 weeks
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Self-report engagement
Time Frame: 9 weeks
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1 item self-report engagement
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9 weeks
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Depressions, anxiety and stress
Time Frame: baseline, 9 weeks and 16 weeks
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Depression, Anxiety and Stress Scale (DASS-21)
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baseline, 9 weeks and 16 weeks
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Well-being at work
Time Frame: baseline, 9 weeks and 16 weeks
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16-item Institute of Work Psychology Multi Affect Indicator
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baseline, 9 weeks and 16 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephany Carolan, MSc, University of Sussex
Publications and helpful links
General Publications
- Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38(4):196-205. doi: 10.1080/16506070903318960.
- Cavanagh, K., & Millings, A. (2013). Increasing engagement with computerised cognitive behavioural therapies. ICST Transactions on Ambient Systems, 13(2), e3. http://doi.org/10.4108/trans.amsys.01-06.2013.e3
- Geraedts AS, Kleiboer AM, Twisk J, Wiezer NM, van Mechelen W, Cuijpers P. Long-term results of a web-based guided self-help intervention for employees with depressive symptoms: randomized controlled trial. J Med Internet Res. 2014 Jul 9;16(7):e168. doi: 10.2196/jmir.3539.
- Carolan S, Harris PR, Greenwood K, Cavanagh K. Increasing engagement with an occupational digital stress management program through the use of an online facilitated discussion group: Results of a pilot randomised controlled trial. Internet Interv. 2017 Aug 24;10:1-11. doi: 10.1016/j.invent.2017.08.001. eCollection 2017 Dec.
- Carolan S, de Visser RO. Employees' Perspectives on the Facilitators and Barriers to Engaging With Digital Mental Health Interventions in the Workplace: Qualitative Study. JMIR Ment Health. 2018 Jan 19;5(1):e8. doi: 10.2196/mental.9146.
- Carolan S, Harris PR, Greenwood K, Cavanagh K. Increasing engagement with, and effectiveness of, an online CBT-based stress management intervention for employees through the use of an online facilitated bulletin board: study protocol for a pilot randomised controlled trial. Trials. 2016 Dec 15;17(1):598. doi: 10.1186/s13063-016-1733-2.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
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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