Better therapy in less time: Real world evaluations of digitally enabled cognitive therapies for PTSD and Social Anxiety Disorder

Research Question: How do internet cognitive therapies for social anxiety disorder (SAD) and posttraumatic stress disorder (PTSD) compare with current NHS psychological treatment as usual (TAU) when delivered by NHS staff to patients with comparable presentations? Are the internet treatments cost-effective?

Background: Social anxiety disorder and PTSD are common in the community (approximately 7% and 4%, respectively), disabling and often chronic in the absence of treatment.

Specialized cognitive therapies (CT-SAD & CT-PTSD) have been shown to be effective and superior to alternative treatments in clinical trials in several countries. NICE recommends the treatments as first-line interventions.

However, shortage of therapists and other issues mean many patients are unable to access the treatments and those who do are given fewer sessions than recommended and, consequently, have less good outcomes. To overcome these problems, we have developed internet versions of the treatments (iCT-SAD & iCT-PTSD).

Patients learn how to overcome their difficulties by working through media-rich, engaging internet programmes that can be accessed 24/7. They receive remote therapist support that takes much less time. Preliminary evaluations show the internet cognitive therapies are acceptable to many patients.

Between study comparisons suggest they may be more effective and cost-effective than psychological treatment as usual in the NHS.

However, this conclusion may be unsafe as there have not been any direct comparisons between the two types of treatment when delivered by NHS staff to comparable individuals.

Aims: To determine the relative effectiveness and cost-effectiveness of internet cognitive therapies in comparison to treatment as usual when deployed in routine NHS psychological therapy services. This is the primary requirement in NICE s evidence generation plans for digital therapies. Methods: Three internet programmes will be evaluated, iCT-PTSD and iCT-SAD for adults and OSCA for SAD in adolescents.

Each will be compared with non-digital psychological treatment as usual in a randomized controlled trial with minimal exclusion criteria as part of a real-world evaluation.

The adult programmes will be tested in four NHS Talking Therapy services and OSCA in two Children and Young People services. Therapists will be routine clinicians in each service.

In view of the positive preliminary findings, the trials are powered for superiority with sample sizes of 220 per trial being adequate to detect a minimal clinically meaningful difference based on expert and user consensus.

The primary outcome is symptom severity on the NHS recognised measure for the relevant disorder at 18 or16 weeks post-randomisation. Follow-ups will also be conducted.

Secondary outcomes include other NHS metrics (reliable recovery, reliable improvement, reliable deterioration), mental health-related disability, quality of life, use of health and social care services, and user & therapist experience with the internet therapies. A full health economic analysis will be conducted.

Timelines for delivery; 36 months including contracts, ethics and R&D approvals, recruitment, treatment and follow-up. Anticipated impact and dissemination.

If the early promise of the internet treatments is confirmed, the planned commercialisation and dissemination strategy will help the NHS offer patients wider choice about how treatment is delivered and ensure many more people have effective treatment.