Nook Non-Inferiority Trial
Research type
Research Study
Full title
Evaluating the efficacy of an AI-delivered, neurosymbolic, human-supervised digital intervention for depression and anxiety versus standard cognitive-behavioural therapy in young persons and adults: a pivotal, randomised, controlled, non-inferiority trial
IRAS ID
369133
Contact name
Shaun Mehew
Contact email
Sponsor organisation
PsyScale Ltd
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
Depression and anxiety are common mental health conditions that affect people of all ages and are increasing in prevalence, particularly among young people. Effective treatments such as cognitive behavioural therapy (CBT), a structured talking therapy that helps people change unhelpful patterns of thinking and behaviour, are available but many people face long waiting times or cannot access them at all due to shortages of trained therapists.
This trial will evaluate Nook, a new digital psychological treatment delivered through a smartphone app or web browser. Nook uses artificial intelligence (AI) to guide users through a structured course of therapy based on established CBT and Acceptance and Commitment Therapy (ACT) techniques. All therapeutic decisions and safety responses are governed by fixed clinical rules, and qualified clinicians monitor each participant's progress and safety throughout treatment.
The study asks whether Nook is at least as effective as standard CBT delivered by a therapist in reducing symptoms of depression and anxiety. It will also assess safety, quality of life, functioning, user experience and potential cost effectiveness.
Approximately 400 participants aged 16 to 64 with mild to moderately severe depression and/or mild to severe anxiety will be recruited across the United Kingdom via social media advertising. Participants will be randomly allocated to receive either Nook or therapist delivered CBT for nine weeks, with a further follow up assessment three months later. All assessments are completed remotely using online questionnaires.
The trial is a non-inferiority study, meaning it is designed to determine whether Nook produces outcomes that are no worse than standard therapy by a clinically meaningful amount. The study is sponsored and funded by PsyScale Ltd, the manufacturer of the device. Recruitment will take place centrally through Lindus Health, a contract research organisation acting as the clinical trial site.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
26/WM/0050
Date of REC Opinion
6 May 2026
REC opinion
Further Information Favourable Opinion