Depression and anxiety (Generalised Anxiety Disorder and/or Major Depressive Disorder) Mental and Behavioural Disorders
Conditions
Interventions
Arm 1 – Nook (Investigational Device): Participants will receive access to Nook, a clinician-supervised, AI-enabled digital psychological intervention developed by PsyScale. Nook delivers structured,
Sponsors
PsyScale Ltd
Eligibility
Sex/Gender
All
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Have symptoms of generalised anxiety disorder and or symptoms of major depressive disorder as the primary reason for seeking treatment as determined by a psychological well-being practitioner 1.1. Symptoms may meet criteria for either or both disorders 2. Meet symptom severity criteria on either validated screening measure 2.1. Depression assessed using PHQ-9 or PHQ-A for young people with a total score between 10 and 19 corresponding to moderate to moderately severe symptoms 2.2. Anxiety assessed using GAD-7 with a total score between 8 and 21 corresponding to mild to severe symptoms 3. Aged 16 to 64 years 4. 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 5. Have reliable access to a compatible internet connected device and be able to use it for screening and eligibility, the intervention and assessments with any potential costs clearly noted in the participant information sheet 6. Possess sufficient English language proficiency and cognitive capacity to engage with the digital therapeutic content and complete questionnaires 7. Provide informed consent 8. Be willing to be randomised and to participate in a clinically supervised CBT based AI programme including completion of scheduled outcome assessments
Exclusion criteria
Exclusion criteria: 1. Depression assessed using PHQ-9 or PHQ-A for young people with a total score of 20 or higher 2. Present with a primary or comorbid diagnosis or history that is unsuitable for a digital CBT based intervention as judged by the investigator, including 2.1. Post traumatic stress disorder or complex trauma 2.2. Psychotic disorder, bipolar disorder and or mania 2.3. Complex or treatment resistant obsessive compulsive disorder 2.4. Personality disorder 2.5. Eating disorder 2.6. Substance use disorder or alcohol use disorder 3. Exhibit high risk clinical concerns, including 3.1. Current suicidal ideation with intent or plan as indicated by PHQ-9 score and or participant disclosure 3.2. Suicide attempt within the past 12 months 3.3. Ongoing self harming behaviours 3.4. Requirement for urgent or crisis mental health intervention as indicated by PHQ-9 score and or participant disclosure 4. In participants aged 25 years and under, current treatment with an antidepressant medication that was initiated or dose adjusted within the past 12 weeks due to the recognised increased risk of suicidal thoughts and behaviours during the early phases of antidepressant treatment in this age group 5. Have been referred to or managed by a mental health crisis intervention team or equivalent, or admitted as an inpatient within psychiatric services in the last 12 months 6. Are currently receiving structured psychological therapy for anxiety or depression delivered by another provider 7. Use of medications indicative of severe mental illness or clinical instability, including 7.1. Antipsychotic medication excluding low dose use for non psychiatric indications where clinically appropriate 7.2. Regular use of sedative hypnotic medication such as daily benzodiazepines or Z drugs suggesting clinical instability 7.3. Current or recent use within the past 3 months of psychedelic assisted therapy involving substances such as MDMA, psilocybin or ketamine, where this indicates ongoing clinical instability or participation in an active interventional mental health treatment 8. Participation in another interventional clinical trial or use of investigational drugs in the last 30 days 9. Any other significant disease or disorder which, in the opinion of the investigator, may put the participant at risk because of participation in the trial, influence the results of the trial, or affect the participant’s ability to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression and anxiety symptom severity measured using Patient Health Questionnaire (PHQ-9 or PHQ-A) and Generalised Anxiety Disorder 7-item scale (GAD-7) at Baseline, 9 weeks post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Caseness recovery measured using PHQ-9 (or PHQ-A) score <10, and/or GAD-7 score <8 at 9 weeks;Reliable improvement measured using a reduction of =6 points on the PHQ-9 (or PHQ-A) and/or =4 points on the GAD-7, without a corresponding reliable deterioration on the other measure (assessed only for participants meeting caseness at baseline) at 9 weeks;Health-related quality of life measured using the EQ-5D-5L (47), a validated, preference-based measure of health-related quality of life that enables estimation of quality-adjusted life years (QALYs) at 9 weeks | — |
Countries
England, United Kingdom
Contacts
Public ContactStephanie Argue
Outcome results
None listed