AI-Supported Therapy for Depression and Anxiety Compared With Standard CBT (NCT07620340) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
AI-Supported Therapy for Depression and Anxiety Compared With Standard CBT
400 participantsStarted 2026-06-01
Plain-language summary
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.
Who can participate
Age range
16 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have symptoms of Generalized Anxiety Disorder (GAD) and/or symptoms of --•Major Depressive Disorder (MDD) as the primary reason for seeking treatment (formal diagnosis not required).(as determined by a Psychological Well-being Practitioner).
* Meet symptom-severity criteria on either validated screening measure:
* Depression: PHQ-9 (or PHQ-A for young persons) total score between 10 and 19, corresponding to moderate to moderately-severe symptoms, and/or
* Anxiety: GAD-7 total score between 8 and 21, corresponding to mild to severe symptoms.
* Aged 16-64 years
* If taking psychotropic medication for depression and/or anxiety, be on a stable regimen for at least 6 weeks prior to screening, with no initiation, discontinuation, or dose change during that period.
* Have reliable access to a compatible, internet-connected device and are able to use it for screening/eligibility, and the intervention and assessments (any potential costs to participants will be clearly noted in the PIS).
* Possess sufficient English language proficiency and cognitive capacity to engage with the digital therapeutic content and complete questionnaires.
* Provide informed consent.
* Willing to be randomised and to participate in a clinically-supervised CBT-based AI programme, including completion of scheduled outcome assessments.
Exclusion Criteria:
* Depression: PHQ-9 (or PHQ-A for young persons) total score \>≥ 20
* Present with a primary or comorbid diagnosis (or history of) t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing an AI-supported therapy against standard CBT for depression and anxiety — given my specific diagnosis, does my doctor think a standard, already-proven CBT program might be a more reliable first step for me right now?
2The trial isn't recruiting yet, so there could be a significant wait before it even starts — how does my doctor recommend I manage my symptoms in the meantime, and would joining a waitlist make sense given where I am right now?
3The trial is listed as Phase NA, which often applies to behavioral or device studies rather than drug trials — can my doctor explain what that means for what's already known about the safety and effectiveness of AI-supported therapy compared to traditional CBT?
4The study is measuring outcomes using the PHQ-9 and GAD-7 questionnaires, which are standard screening tools — can my doctor walk me through what my current scores on those look like, and how that might affect whether this trial is even designed for someone at my level of severity?
5Since the trial includes both an adult depression measure (PHQ-9) and an adolescent version (PHQ-A), can my doctor clarify which version would apply to me and whether that affects how my progress would be tracked throughout the study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient Health Questionnaire - 9 items (PHQ-9)
Timeframe: Starting at Baseline, taken 3-weekly, to a 9 week end-point post-randomisation
2
Patient Health Questionnaire - Adolescent (PHQ-A)
Timeframe: Starting at Baseline, taken 3-weekly, with a 9 week end-point post randomisation.
3
Generalized Anxiety Disorder assessment (GAD-7)
Timeframe: Starting at Baseline, taken 9-weekly, to a 9-week end point, post-randomisation