Emotional StressNCT02729987
Increasing Engagement With Online Stress Management Interventions
A study testing WorkGuru in people with Emotional Stress, run by University of Sussex at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional Stress
- What is being tested?
- WorkGuru
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or over
- Employed by a participating organisation, ≥ 20 on the Perceived Stress Scale
- Access to a computer/table and the internet
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Emotional Stress
- Being tested
- WorkGuru
- Keywords
- online, internet, CBT, Stress, Work, Internet based treatment
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WorkGuruBehavioural
A multi-modal stress management intervention accessed over 8 weeks, incorporates CBT, positive psychology and Mindfulness. Delivered via the internet.
| Study group | Role | What they receive |
|---|---|---|
| Minimum Support Group (MSG) | Experimental | Intervention group with 8 week access to the online stress management programme with minimal support from a coach (WorkGuru). Receives: Behavioral: WorkGuru |
| Discussion Group | Experimental | 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). Receives: Behavioral: WorkGuru |
| Waiting List Control (WLC) | No intervention | Control group with access to the intervention after 16 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of log-in to the site
number of times participants log in to the website
Measured: 9 weeks
Secondary outcomes (5)
Number of modules completed
number of modules completed
Measured: 9 weeks
Number of pages visited
number of pages visited
Measured: 9 weeks
Self-report engagement
1 item self-report engagement
Measured: 9 weeks
Depressions, anxiety and stress
Depression, Anxiety and Stress Scale (DASS-21)
Measured: baseline, 9 weeks and 16 weeks
Well-being at work
16-item Institute of Work Psychology Multi Affect Indicator
Measured: baseline, 9 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Emotional StressStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sussex
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephany Carolan, MSc, Principal investigator, University of Sussex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729987
- Sponsor's protocol ID
- ER/SC587/1
- Status last verified
- May 2017
- First submitted
- 18 Mar 2016
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 20183695Cavanagh, 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.
PubMed 25008127Carolan 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.
PubMed 30135747Carolan 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.
PubMed 29351900Carolan 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.
PubMed 27978858
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02729987
- Acronym / sponsor ID
- ER/SC587/1
- Conditions
- Emotional Stress
- Keywords
- online, internet, CBT, Stress, Work, Internet based treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of SussexUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Apr 2016 (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.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Minimum Support Group (MSG) | Experimental | Behavioral: WorkGuruIntervention group with 8 week access to the online stress management programme with minimal support from a coach (WorkGuru). |
| Discussion Group | Experimental | Behavioral: WorkGuruIntervention 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). |
| Waiting List Control (WLC) | No intervention | –Control group with access to the intervention after 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 or over
- Employed by a participating organisation, ≥ 20 on the Perceived Stress Scale
- Access to a computer/table and the internet
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| WorkGuruA multi-modal stress management intervention accessed over 8 weeks, incorporates CBT, positive psychology and Mindfulness. Delivered via the internet. | Behavioural | Discussion Group, Minimum Support Group (MSG) |
Primary outcome
Number of log-in to the site
Time frame: 9 weeks
number of times participants log in to the website
5 secondary outcomes
Number of modules completed
Time frame: 9 weeks
Number of pages visited
Time frame: 9 weeks
Self-report engagement
Time frame: 9 weeks
Depressions, anxiety and stress
Time frame: baseline, 9 weeks and 16 weeks
Well-being at work
Time frame: baseline, 9 weeks and 16 weeks
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 4 May 2017.
- Background: PubMed 20183695Andersson 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.
- BackgroundCavanagh, 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
- Background: PubMed 25008127Geraedts 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.
- Derived from this study: PubMed 30135747Carolan 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.
- Derived from this study: PubMed 29351900Carolan 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.
- Derived from this study: PubMed 27978858Carolan 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.
- Stress management interventionLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Stephany Carolan, MSc principal investigator
University of Sussex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WorkGuru in people with Emotional Stress, run by University of Sussex at 1 site in United Kingdom.
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 3 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 4 May 2017. 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 Kingdom. 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?
Number of log-in to the site (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02729987, which also lists 6 linked publications.
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 4 May 2017.