AI-Supported Therapy for Depression and Anxiety Compared With Standard CBT
2026년 6월 2일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
400
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
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- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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.
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A course of human delivered CBT by qualified therapists
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실험적: 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.
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An AI-guided course of digital CBT with human clinician oversight
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient Health Questionnaire - 9 items (PHQ-9)
기간: Starting at Baseline, taken 3-weekly, to a 9 week end-point post-randomisation
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A symptom measure of depression, ranging from 0 to 27. 27 being severe (high).
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Starting at Baseline, taken 3-weekly, to a 9 week end-point post-randomisation
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Patient Health Questionnaire - Adolescent (PHQ-A)
기간: Starting at Baseline, taken 3-weekly, with a 9 week end-point post randomisation.
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A symptom measure of depression for adolescents, ranging from 0 to 27. 27 being severe (high).
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Starting at Baseline, taken 3-weekly, with a 9 week end-point post randomisation.
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Generalized Anxiety Disorder assessment (GAD-7)
기간: Starting at Baseline, taken 9-weekly, to a 9-week end point, post-randomisation
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A symptom measure of anxiety, ranging from 0 to 21. 21 being severe (high).
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Starting at Baseline, taken 9-weekly, to a 9-week end point, post-randomisation
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2026년 9월 9일
연구 완료 (추정된)
2027년 1월 7일
연구 등록 날짜
최초 제출
2026년 5월 27일
QC 기준을 충족하는 최초 제출
2026년 5월 27일
처음 게시됨 (실제)
2026년 6월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 2일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .