Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
PsyScale
Age
16–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
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
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