AI-Supported Therapy for Depression and Anxiety Compared With Standard CBT

May 27, 2026 updated by: PsyScale

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CBT Comparator
Participants randomised to the comparator arm will receive standard cognitive behavioural therapy (CBT) delivered remotely by qualified CBT practitioners. Therapy will be provided in accordance with routine evidence-based clinical practice, with participants undergoing the same assessment and safety monitoring schedule as the intervention arm.
Behavioral: Cognitive Behavioural Therapy
A course of human delivered CBT by qualified therapists
Experimental: Nook
Description: Participants randomised to the intervention arm will receive access to Nook, a digitally delivered psychological intervention designed to support individuals experiencing symptoms of depression and anxiety. The intervention is delivered remotely through a secure digital platform and incorporates structured therapeutic content alongside clinician oversight and safety monitoring procedures.
Device: AI-Digital CBT
An AI-guided course of digital CBT with human clinician oversight

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depression symptom severity (PHQ-9 / PHQ-A)
Time Frame: Baseline to Week 9 post-randomisation
Baseline to Week 9 post-randomisation
Anxiety symptom severity (GAD-7)
Time Frame: Baseline to Week 9 post-randomisation
Baseline to Week 9 post-randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PsyScale

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 9, 2026

Study Completion (Estimated)

January 7, 2027

Study Registration Dates

First Submitted

May 27, 2026

First Submitted That Met QC Criteria

May 27, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 369133

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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