This study is a pivotal, randomised, controlled, non-inferiority trial evaluating "Nook," an AI-delivered, neurosymbolic, clinician-supervised digital psychological intervention for depression and anxiety, compared with standard cognitive behavioural therapy (CBT). The trial will recruit 400 participants aged 16-64 years in the UK with moderate depression and/or anxiety symptoms. Participants will be randomised to receive either Nook or therapist-delivered CBT. The primary objective is to determine whether Nook is non-inferior to CBT in reducing depression and anxiety symptoms, measured using the PHQ-9/PHQ-A and GAD-7 scales. Secondary outcomes include quality of life, functional impairment, sleep quality, treatment engagement, participant satisfaction, safety outcomes, and exploratory health economic measures. The intervention incorporates clinician oversight and predefined escalation pathways for suicidality and clinical deterioration. Outcomes will be analysed using longitudinal mixed-effects models under an intention-to-treat framework.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
An AI-guided course of digital CBT with human clinician oversight
A course of human delivered CBT by qualified therapists
Patient Health Questionnaire - 9 items (PHQ-9)
A symptom measure of depression, ranging from 0 to 27. 27 being severe (high).
Time frame: Starting at Baseline, taken 3-weekly, to a 9 week end-point post-randomisation
Patient Health Questionnaire - Adolescent (PHQ-A)
A symptom measure of depression for adolescents, ranging from 0 to 27. 27 being severe (high).
Time frame: Starting at Baseline, taken 3-weekly, with a 9 week end-point post randomisation.
Generalized Anxiety Disorder assessment (GAD-7)
A symptom measure of anxiety, ranging from 0 to 21. 21 being severe (high).
Time frame: Starting at Baseline, taken 9-weekly, to a 9-week end point, post-randomisation
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