BACKGROUND
Depression is a common mental health problem with significant personal and social consequences. Studies have suggested that cognitive behavioural therapy (CBT) is an effective treatment for depression and anxiety when delivered one to one by an expert practitioner, but access to this talking therapy is often limited and waiting lists can be long. However, a range of low intensity interventions that can increase access to services are available including guided CBT self-help materials delivered via books, classes and as online packages.
OBJECTIVE
This project aimed to pilot a randomised controlled trial of an online CBT-based life skills course with community-based individuals experiencing depression.
METHODS
Individuals with symptoms of depression were recruited directly from the community via newspaper advertisements. Participants were remotely randomised to receive either immediate access (IA) or delayed access (DA) to a research version of the Living Life to the Full online CBT-based life skills package (3rd edition) with telephone support provided by non-specialist charity-based workers whilst they used the online intervention. The primary end point was at 3 months post-randomisation, at which point the delayed access group were offered the intervention. Levels of depression, anxiety, social functioning and satisfaction were assessed.
RESULTS
There was effective recruitment, randomisation and uptake with 19 Immediate Access (IA) and 17 Delayed Access Control (DAC) participants entering the pilot study via newspaper adverts and 13 of the 19 participants taking up the intervention. Overall (72%) were not currently under the care of their general practitioner (GP). The online package was acceptable to participants, the mean satisfaction score on the Client Satisfaction Questionnaire was 21 out of 32 (sd = 8.89). At three months, data collection was achieved from 28/36 (78%) of participants. The efficacy and retention data were used for a power calculation indicating that 72 participants in total will be required for a future substantive RCT.
CONCLUSIONS
The research design successfully tested the recruitment, data collection and intervention delivery. The pilot study has provided data for the required sample size for the full RCT.
CLINICALTRIAL
ISRCTN registry ID: ISRCTN12890709. Date assigned: 28/07/15.
INTERNATIONAL REGISTERED REPORT
RR2-10.1186/s13063-016-1336-y