Title: Integrated therapist and online CBT for depression in primary care
Funder: Department of Health and Social Care

Abstract: Aims and Objectives: The aim is to integrate online cognitive behavioural therapy (CBT) materials with input from an accredited CBT therapist in order to increase the availability of high intensity CBT for patients with depression in UK primary care. Objectives: To identify clinical and cost-effective components of CBT to inform the development of the intervention To develop: (1) an online platform to support the delivery of integrated CBT; (2) online CBT materials; and (3) an online training package for therapists To examine the clinical and cost-effectiveness of an integrated approach to delivering CBT for depression over 12 months To explore patients and therapists views and experiences of using this approach Background and rationale: There is a gap in the provision of high intensity CBT. Computerised CBT (cCBT) programmes are inexpensive but lack flexibility and, in the absence of therapist support, effects are modest and short-term. Real-time delivery of CBT online is acceptable and effective. Technological advancements make it possible to reduce therapist time and incorporate online materials and use of mobile devices as integral parts of therapy in a way that permits the therapist to adapt CBT to the patient s needs. This novel integration, which blends high intensity therapy with innovative use of technology to maintain the effectiveness of face-to-face CBT, needs to be evaluated in terms of clinical and cost-effectiveness, and acceptability. It will increase the general availability of CBT and include hard-to-reach groups and those for whom access is difficult. Research plan: Work-stream 1: Development of the IT platform and CBT content. Part 1: Identification of clinically effective components of CBT using multiple treatment meta-analysis. Part 2: Identification of cost-effective components of CBT using a decision analytic framework. Part 3: Development of the online platform by software engineers and experts in Human Computer Interaction. It will incorporate multiple channels of communication and support. There will be three iterations of design, development and user evaluation. Part 4: Development of CBT resources for the platform, and a training package for therapists. Work-stream 2: Multi-centre randomised controlled trial (RCT) of an integrated approach to delivering CBT for depression To establish the clinical effectiveness of an integrated approach to delivering CBT in reducing depressive symptoms and improving quality of life over 12 months (compared with usual care) for primary care patients with depression. Two parallel group multi-centre RCT with allocation at the level of the individual set in primary care in Bristol, London and Hull/York. Participants will be randomised to the intervention or usual care (including referral for supported cCBT). The integrated approach will be introduced in a face-to-face session, followed by 5-8 sessions online in real-time. Patients will work through online materials between sessions . The primary outcome will be score on the Beck Depression Inventory (BDI-II) at 6 months. Secondary outcomes will include response (at least 50% reduction of symptoms), remission (BDI-II score Work-stream 3 will evaluate the cost effectiveness from the perspectives of NHS and personal social services, patients and carers, and society. Work-stream 4: Qualitative study nested within the trial exploring patients and therapists views and experiences of the intervention (including the therapist-patient relationship, flexibility of session timing and between session work). Projected outputs and dissemination plans: We will publish in high impact peer review journals and target the main UK scientific audiences at conference presentations. The programme will inform future guidelines, including NICE. Service user team members will assist in dissemination including to charities such as Depression Alliance and the Mental Health Foundation. We will disseminate results to participants, GPs and online support communities. Adoption of the intervention into clinical practice will be facilitated by the mental health commissioning lead for Bristol CCG (co-applicant). Benefits to patients and the NHS: Depression is a leading cause of disability and ways to increase the availability of effective treatments are needed. NICE advocates psychological therapies for those with more severe depression or who have not responded to initial treatments, and many patients prefer such therapies; a key question for commissioners and health care providers is how to increase access to high intensity CBT without delay and without greatly increasing costs. An IT platform integrating the use of technology with reduced therapist contact time could increase efficiency whilst maintaining the long-term effectiveness of CBT. It could also widen access to populations that are difficult to reach, including those with a disability or who find it difficult to attend appointments. This work has the potential to make a substantial impact on the health of the population within 5 years as the intervention will be ready for adoption in the NHS.

Lay abstract: Depression has a great human and economic cost. Antidepressants are the mainstay of treatment, although many depressed people say they would prefer psychological therapy. In recent years the availability of psychological treatments, especially for those with less severe problems, has increased. However, many people with depression are unable to get individual cognitive behavioural therapy (CBT), even though this therapy is recommended by NICE for a wide range of people (those who prefer psychological treatment and those with more severe depression), and we have shown that it is effective for people who do not respond to antidepressants. One of the reasons for this is a lack of CBT therapists; another is cost. To address this problem, computerised self-help packages based on CBT have been developed. However, these are of only modest effectiveness, and patients often do not engage with them. Our aim is to integrate online CBT materials and input from an accredited CBT therapist, to deliver effective CBT to those who need it. This could lead to cost savings and increase availability, including for those for whom access is difficult (working full-time/living in remote areas/with caring responsibilities and hard-to-reach groups). The therapist will meet the patient for the first session, but thereafter will deliver therapy online by instant messaging in real-time at pre-arranged appointments; we have previously shown this is effective and acceptable. Patients will also have high quality materials to work with between sessions. We will improve engagement with online therapy by building the package around the relationship with the therapist. Appointments can be made out of hours at convenient times. We will use the latest online technology and devices, including smart phones and tablets, to enable people to record their thoughts and feelings with greater accuracy and immediacy and conduct psychological exercises at convenient times. There will be four elements to our programme of work. Developmental phase: we will work with stakeholders to develop the IT platform, the online materials and a training package for therapists. Randomised controlled trial: we will test the package in depressed patients recruited from general practice. We will ask depressed patients if they wish to join the trial and then randomly allocate them to receive either the package developed by us or usual care (including supported computerised CBT). This means we will have an unbiased assessment of the effectiveness of our intervention. Assessment of the cost effectiveness of the package to see if it represents value for money. In-depth interview study: we will ask patients and therapists what they think of the package. This work has the potential to make CBT more widely available to those who most need it, and to deliver it at lower cost.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH