AI-Supported Therapy for Depression and Anxiety Compared With Standard CBT
2026年6月2日 更新者：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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
400
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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
|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient Health Questionnaire - 9 items (PHQ-9)
時間枠：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)
時間枠：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)
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2026年9月9日
研究の完了 (推定)
2027年1月7日
試験登録日
最初に提出
2026年5月27日
QC基準を満たした最初の提出物
2026年5月27日
最初の投稿 (実際)
2026年6月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月4日
QC基準を満たした最後の更新が送信されました
2026年6月2日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。