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Can an AI therapist match a human one? new trial aims to find out

NCT ID NCT07620340

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares an AI-delivered digital therapy called Nook to standard cognitive behavioural therapy (CBT) for people with moderate depression and/or anxiety. 400 participants aged 16-64 in the UK will be randomly assigned to either the AI program or human-led therapy. The goal is to see if the AI approach works as well as traditional therapy in reducing symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AI-guided digital cognitive behavioural therapy (CBT) with clinician oversight
What this could lead to
If it works, this could offer a more accessible, scalable alternative to traditional therapy for depression and anxiety.
What could go wrong
This is an early-stage non-inferiority trial; the AI therapy may not be as effective as human-led CBT, and results may not apply to severe cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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) that is unsuitable for a digital CBT-based intervention (as judged by the Investigator), including: * Post-traumatic stress disorder (PTSD) or complex trauma * Psychotic disorder, bipolar disorder, and/or mania * Complex or treatment-resistant obsessive-compulsive disorder (OCD) * Personality disorder * Eating disorder * Substance or alcohol use disorder * Exhibit high-risk clinical concerns, including: * Current suicidal ideation with intent or plan (as indicated by PHQ-9 score and/or participant disclosure) * Suicide attempt within the past 12 months * Ongoing self-harming behaviours * Requirement for urgent or crisis mental-health intervention (as indicated by •PHQ-9 score and/or participant disclosure) * In participants aged 25 years and under, current treatment with an antidepressant medication initiated or dose-adjusted within the past 12 weeks (due to the recognised

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.