• Trials · Apr 2016

    Randomized Controlled Trial

    Online CBT life skills programme for low mood and anxiety: study protocol for a pilot randomized controlled trial.

    • Christopher Williams, Carrie-Anne McClay, Rebeca Martinez, Jill Morrison, Caroline Haig, Ray Jones, and Paul Farrand.
    • Institute of Health and Wellbeing, University of Glasgow, Gartnavel Royal Hospital, 1st Floor Administration Building, 1055 Great Western Road, Glasgow City, G12 0XH, Scotland, UK. chris.williams@glasgow.ac.uk.
    • Trials. 2016 Apr 27; 17 (1): 220.

    BackgroundLow mood is a common mental health problem with significant health consequences. Studies have shown that cognitive behavioural therapy (CBT) is an effective treatment for low mood and anxiety when delivered one-to-one by an expert practitioner. However, access to this talking therapy is often limited and waiting lists can be long, although a range of low-intensity interventions that can increase access to services are available. These include guided self-help materials delivered via books, classes and online packages. This project aims to pilot a randomized controlled trial of an online CBT-based life skills course with community-based individuals experiencing low mood and anxiety.MethodsIndividuals with elevated symptoms of depression will be recruited directly from the community via online and newspaper advertisements. Participants will be remotely randomized to receive either immediate access or delayed access to the Living Life to the Full guided online CBT-based life skills package, with telephone or email support provided whilst they use the online intervention. The primary end point will be at 3 months post-randomization, at which point the delayed-access group will be offered the intervention. Levels of depression, anxiety, social functioning and satisfaction will be assessed.DiscussionThis pilot study will test the trial design, and ability to recruit and deliver the intervention. Drop-out rates will be assessed and the completion and acceptability of the package will be investigated. The study will also inform a sample size power calculation for a subsequent substantive randomized controlled trial.Trial RegistrationISRCTN ISRCTN12890709.

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