Digital IAPT: the effectiveness & cost-effectiveness of internet-delivered interventions for depression and anxiety disorders in the Improving Access to Psychological Therapies programme: study protocol for a randomised control trial

Derek Richards, Daniel Duffy, Brid Blackburn, Caroline Earley, Angel Enrique, Jorge Palacios, Matthew Franklin, Gabriella Clarke, Sarah Sollesse, Sarah Connell, Ladislav Timulak, Derek Richards, Daniel Duffy, Brid Blackburn, Caroline Earley, Angel Enrique, Jorge Palacios, Matthew Franklin, Gabriella Clarke, Sarah Sollesse, Sarah Connell, Ladislav Timulak

Abstract

Background: Depression 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.

Methods: The 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.

Discussion: This 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 registration: Current 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).

Keywords: Anxiety; Depression; IAPT; Internet-delivered; RCT; iCBT.

Conflict of interest statement

Ethics approval and consent to participate

Human subjects’ approval and all information and related materials for the trial has received a favorable report from the NHS North-West Haydock Research Committee (May 16th, 2017; IRAS ID: 214669). Information about participating, including the objectives of the trial, will be made available to all prospective participants. Each patient will be given a unique username and password to log on and begin his/her treatment. Informed consent will be collected from all participants. The researchers are not aware of any unforeseen adverse effects of participating in the study. The interventions involve a platform (SilverCloud) which is evidence-based and is widely used throughout NHS services.

Consent for publication

Not applicable.

Competing interests

DR, DD, AE, JP, CE, and SC, are employees of SilverCloud Health, developers of computerised psychological interventions for depression, anxiety, stress and comorbid long-term conditions.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

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Fig. 1
Participant flow – CONSORT

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