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

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