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


METHODS
Individuals 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.


CONCLUSIONS
This 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.


BACKGROUND
ISRCTN ISRCTN12890709.
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.
Christopher
C
Williams
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.
Carrie-Anne
CA
McClay
Mersey Care NHS Trust, Ferndale Unit, University Hospital Aintree, Lower Lane, Liverpool, L9 7AL, England, UK.
Rebeca
R
Martinez
General Practice & Primary Care, Institute of Health and Wellbeing, University of Glasgow, 1 Horselethill Road, Glasgow, G12 9LX, Scotland, UK.
Jill
J
Morrison
Robertson Centre for Biostatistics, Boyd Orr Building, University of Glasgow, Glasgow, G12 8QQ, Scotland, UK.
Caroline
C
Haig
Faculty of Health and Human Sciences, University of Plymouth, Drake Circus, Plymouth, Devon, PL4 8AA, England, UK.
Ray
R
Jones
Clinical Education, Development and Research (CEDAR); Psychology, University of Exeter, Washington Singer Laboratories, Perry Road, Exeter, EX4 4QG, UK.
Paul
P
Farrand
D000223:Adaptation, Psychological; D000339:Affect; D001007:Anxiety / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003863:Depression / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D006801:Humans; D020407:Internet; D010352:Patient Dropouts; D017060:Patient Satisfaction; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D012648:Self Care; D012919:Social Behavior; D013813:Therapy, Computer-Assisted; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
Anxiety; Bibliotherapy; Depression; Guided self-help; Life skills; Low mood; Online; Psychotherapy; RCT; Treatment gap; computerized CBT