NCT02729987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

March 18, 2016

Last Update Submit

May 3, 2017

Conditions

Keywords

onlineinternetCBTStressWorkInternet based treatment

Outcome Measures

Primary Outcomes (1)

  • Number of log-in to the site

    number of times participants log in to the website

    9 weeks

Secondary Outcomes (5)

  • Number of modules completed

    9 weeks

  • Number of pages visited

    9 weeks

  • Self-report engagement

    9 weeks

  • Depressions, anxiety and stress

    baseline, 9 weeks and 16 weeks

  • Well-being at work

    baseline, 9 weeks and 16 weeks

Study Arms (3)

Minimum Support Group (MSG)

EXPERIMENTAL

Intervention group with 8 week access to the online stress management programme with minimal support from a coach (WorkGuru).

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).

Behavioral: WorkGuru

Waiting List Control (WLC)

NO INTERVENTION

Control group with access to the intervention after 16 weeks

Interventions

WorkGuruBEHAVIORAL

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

Discussion GroupMinimum Support Group (MSG)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 or over
  • Employed by a participating organisation, ≥ 20 on the Perceived Stress Scale
  • Access to a computer/table and the internet

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WorkGuru

Brockenhurst, Hampshire, SO42 7RA, United Kingdom

Location

Related Publications (6)

  • 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.

    PMID: 20183695BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 25008127BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Stephany Carolan, MSc

    University of Sussex

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2016

First Posted

April 6, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations