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

2. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

400

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Adfærdsmæssigt: Cognitive Behavioural Therapy
A course of human delivered CBT by qualified therapists
Eksperimentel: 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.
Enhed: AI-Digital CBT
An AI-guided course of digital CBT with human clinician oversight

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Health Questionnaire - 9 items (PHQ-9)
Tidsramme: Starting at Baseline, taken 3-weekly, to a 9 week end-point post-randomisation
A symptom measure of depression, ranging from 0 to 27. 27 being severe (high).
Starting at Baseline, taken 3-weekly, to a 9 week end-point post-randomisation
Patient Health Questionnaire - Adolescent (PHQ-A)
Tidsramme: Starting at Baseline, taken 3-weekly, with a 9 week end-point post randomisation.
A symptom measure of depression for adolescents, ranging from 0 to 27. 27 being severe (high).
Starting at Baseline, taken 3-weekly, with a 9 week end-point post randomisation.
Generalized Anxiety Disorder assessment (GAD-7)
Tidsramme: Starting at Baseline, taken 9-weekly, to a 9-week end point, post-randomisation
A symptom measure of anxiety, ranging from 0 to 21. 21 being severe (high).
Starting at Baseline, taken 9-weekly, to a 9-week end point, post-randomisation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

PsyScale

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

9. september 2026

Studieafslutning (Anslået)

7. januar 2027

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 369133

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Major Depressive Disorder (MDD)

Kliniske forsøg med Cognitive Behavioural Therapy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Germany

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner