NCT07620340Toborzás még nem indult
AI-Supported Therapy for Depression and Anxiety Compared With Standard CBT
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 4.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 400 (tervezett)
- Első benyújtás
- 2026. máj. 27.
- Kezdés
- 2026. jún. 1.
- Elsődleges befejezés
- 2026. szept. 9.
- Fő szponzor
- PsyScale
- Betegségek
- Depresszió
- NCT-szám
- NCT07620340
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 400
- 2026. jún. 1. és az elsődleges befejezés (2026. szept. 9.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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
Más betegség
- 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
Egyéb
- Depression: PHQ-9 (or PHQ-A for young persons) total score >≥ 20
- 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)
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 16 év – 64 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.