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Increasing Engagement With Online Stress Management Interventions

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ClinicalTrials.gov Identifier: NCT02729987
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
University of Sussex

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Emotional Stress Behavioral: WorkGuru Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : April 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016
Arms and Interventions
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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).
 Behavioral: WorkGuru
A multi-modal stress management intervention accessed over 8 weeks, incorporates CBT, positive psychology and Mindfulness. Delivered via the internet.
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).
 Behavioral: 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


Outcome Measures
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Primary Outcome Measures :
  1. Number of log-in to the site [ Time Frame: 9 weeks ]
    number of times participants log in to the website


Secondary Outcome Measures :
  1. Number of modules completed [ Time Frame: 9 weeks ]
    number of modules completed

  2. Number of pages visited [ Time Frame: 9 weeks ]
    number of pages visited

  3. Self-report engagement [ Time Frame: 9 weeks ]
    1 item self-report engagement

  4. Depressions, anxiety and stress [ Time Frame: baseline, 9 weeks and 16 weeks ]
    Depression, Anxiety and Stress Scale (DASS-21)

  5. Well-being at work [ Time Frame: baseline, 9 weeks and 16 weeks ]
    16-item Institute of Work Psychology Multi Affect Indicator


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729987


Locations
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United Kingdom
WorkGuru
Brockenhurst, Hampshire, United Kingdom, SO42 7RA
Sponsors and Collaborators
University of Sussex
Investigators
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Principal Investigator: Stephany Carolan, MSc University of Sussex
More Information
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Additional Information:

Publications:
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Sussex
ClinicalTrials.gov Identifier: NCT02729987    
Other Study ID Numbers: ER/SC587/1
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Sussex:
online
internet
CBT
 Stress
Work
Internet based treatment
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms