Increasing Engagement With Online Stress Management Interventions

Emotional Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729987
• Other study ID #: ER/SC587/1
• Status: Completed
• Phase: N/A
• First received: March 18, 2016
• Last updated: May 3, 2017
• Start date: April 2016
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: University of Sussex
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this pilot study is to explore the effect of an online facilitated discussion group on engagement with a stress management intervention delivered to employees in the UK via the Internet. The investigators primary hypothesis is that the intervention group with access to an online facilitated discussion group (delivered via a message board) will show greater engagement than the intervention group that does not have access to the discussion group. The investigators also hypothesise that participants in the intervention groups will improve significantly on psychological distress and subjective wellbeing measures compared to the waiting list control group, and that the group with access to the online facilitated discussion group will show the greatest improvement.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Emotional Stress
• Stress, Psychological

Intervention

Behavioral:
• WorkGuru
A multi-modal stress management intervention accessed over 8 weeks, incorporates CBT, positive psychology and Mindfulness. Delivered via the internet.

Locations

Country	Name	City	State
United Kingdom	WorkGuru	Brockenhurst	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Sussex

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of log-in to the site	number of times participants log in to the website	9 weeks
Secondary	Number of modules completed	number of modules completed	9 weeks
Secondary	Number of pages visited	number of pages visited	9 weeks
Secondary	Self-report engagement	1 item self-report engagement	9 weeks
Secondary	Depressions, anxiety and stress	Depression, Anxiety and Stress Scale (DASS-21)	baseline, 9 weeks and 16 weeks
Secondary	Well-being at work	16-item Institute of Work Psychology Multi Affect Indicator	baseline, 9 weeks and 16 weeks

External Links

•   Stress management intervention