Abstract
BackgroundDepression and anxiety are common mental health disorders worldwide. The UK’s Improving Access to Psychological Therapies (IAPT) programme is part of the National Health Service (NHS) designed to provide a stepped care approach to treating people with anxiety and depressive disorders. Cognitive Behavioural Therapy (CBT) is widely used, with computerised and internet-delivered cognitive behavioural therapy (cCBT and iCBT, respectively) being a suitable IAPT approved treatment alternative for step 2, low- intensity treatment. iCBT has accumulated a large empirical base for treating depression and anxiety disorders. However, the cost-effectiveness and impact of these interventions in the longer-term is not routinely assessed by IAPT services. The current study aims to evaluate the clinical and cost-effectiveness of internet-delivered interventions for symptoms of depression and anxiety disorders in IAPT.MethodsThe study is a parallel-groups, randomised controlled trial examining the effectiveness and cost-effectiveness of iCBT interventions for depression and anxiety disorders, against a waitlist control group. The iCBT treatments are of 8 weeks duration and will be supported by regular post-session feedback by Psychological Wellbeing Practitioners. Assessments will be conducted at baseline, during, and at the end of the 8-week treatment and at 3, 6, 9, and 12-month follow-up. A diagnostic interview will be employed at baseline and 3-month follow-up. Participants in the waitlist control group will complete measures at baseline and week 8, at which point they will receive access to the treatment. All adult users of the Berkshire NHS Trust IAPT Talking Therapies Step 2 services will be approached to participate and measured against set eligibility criteria. Primary outcome measures will assess anxiety and depressive symptoms using the GAD-7 and PHQ-9, respectively. Secondary outcome measures will allow for the evaluation of long-term outcomes, mediators and moderators of outcome, and cost-effectiveness of treatment. Analysis will be conducted on a per protocol and intention-to-treat basis.DiscussionThis study seeks to evaluate the immediate and longer-term impact, as well as the cost effectiveness of internet-delivered interventions for depression and anxiety. This study will contribute to the already established literature on internet-delivered interventions worldwide. The study has the potential to show how iCBT can enhance service provision, and the findings will likely be generalisable to other health services.Trial registrationCurrent Controlled Trials ISRCTN ISRCTN91967124. DOI: https://doi.org/10.1186/ISRCTN91967124. Web: http://www.isrctn.com/ISRCTN91967124.Clinicaltrials.gov: NCT03188575. Trial registration date: June 8, 2017 (prospectively registered).
Highlights
Depression and anxiety are common mental health disorders worldwide
The study has the potential to show how internetdelivered cognitive behaviour therapy (iCBT) can enhance service provision, and the findings will likely be generalisable to other health services
We hypothesize that: a) the iCBT interventions will be more effective than the waiting-list group in treating depression and anxiety disorders; b) the iCBT interventions will be cost-effective compared to the waiting-list group in treating depression and anxiety; c) we expect that mediators/ mechanisms of change including, repetitive negative thinking styles, emotion regulation skills, therapeutic alliance, credibility and expectancy in iCBT, Cognitive Behavioural Therapy (CBT) skills usage and therapist behaviours will be identified as positively impacting post-treatment outcomes and maintenance of gains in iCBT
Summary
Study setting Study setting This naturalistic study will be conducted within Berkshire Healthcare NHS Foundation Trust through Talking Therapies, an NHS IAPT provider, that serves a population of 900,000 across 7 Clinical Commissioning Groups (CCGs), all of which are demographically and economically diverse, ranging from rural West Berkshire to urban commuter towns close to London. For the purpose of the economic evaluation, EQ-5D5 L and ReQoL-10 preference-based tariff score values will be used to elicit the quality adjusted life year (QALY) using the area under the curve (AUC) method to account for the collection of this data at multiple time points between baseline and 12-month follow-up in both trial-arms. These EVI results can be used to suggest the upper bound cost of future research around this area of care
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