Abstract
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
Highlights
Low mood is a common mental health problem with significant health consequences
Importance of the project Depression is the main contributor to the global burden of disease [1] and has a significant impact on sufferers’ lives
Low-intensity interventions, such as online cognitive behavioural therapy (CBT) courses can potentially bridge the gap between onset of depression and receiving appropriate treatment by increasing access to psychological therapies
Summary
Overview The study will be a parallel, two-arm pilot RCT with a 50:50 allocation ratio across the two groups. Participants’ ID numbers will be passed to a separate researcher who will use the randomization function in Excel to assign participants remotely to the immediate immediate-access or delayed-access group As this is a pilot study, we will not stratify for any variables during randomization. The two groups of participants will be followed up in exactly the same way Those in the immediate-access group will be given an access code and link to the LLTTF website, including instructions on using the resources. NICE specifications The NICE guidelines [2] for the treatment of adults with depression advise on the content of online selfhelp packages These guidelines state that such interventions should: Risk management A potential risk to participants is that they might experience an increase in their feelings of low mood or anxiety during the study. Progression criteria to a full RCT would be based on adequate recruitment, evidence of possible clinical efficacy and ability to deliver the intervention and collect research data
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