AI-Supported Therapy for Depression and Anxiety Compared With Standard CBT
2 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
400
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / 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.
|
A course of human delivered CBT by qualified therapists
|
|
Experimentell: 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.
|
An AI-guided course of digital CBT with human clinician oversight
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient Health Questionnaire - 9 items (PHQ-9)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
9 september 2026
Avslutad studie (Beräknad)
7 januari 2027
Studieregistreringsdatum
Först inskickad
27 maj 2026
Först inskickad som uppfyllde QC-kriterierna
27 maj 2026
Första postat (Faktisk)
2 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 369133
Läkemedels- och apparatinformation, studiedokument
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