Depression
Conditions
Interventions
Pharmaceutical Form:
Sponsors
University of York
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Our target population will be adult patients, aged 18 and above with depression who are not currently in receipt of computerised CBT or specialist psychological therapy. Our inclusion threshold will be a score of >=10 on the PHQ9 depression severity instrument. This cut point is known to detect clinical depression (major depression) in a UK primary care population with sensitivity = 91.7% and specificity = 78.3%. We will also include patients with either co-morbid physical illness or co-morbid non-psychotic functional disorders, such as anxiety. We will include both incident and prevalent cases. In line with the pragmatic nature of this trial, we will reflect usual GP care and participants will be eligible to participate whether they are in receipt of antidepressant medication or not. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: We will exclude patients who are actively suicidal; suffering psychotic symptoms; depressed in the post-natal period; or have recently suffered bereavement. Patients with previous treatment experience of CBT will not be excluded. We will exclude cases of psychotic depression, since computerised therapy is not recommended within NICE guidance, and are also unlikely to be recruited or randomised by general practitioners to receive computerised CBT, since they are unlikely to have sufficient equipoise in this case.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To establish the clinical and cost effectiveness of the addition of computerised CBT to usual GP care over a two year follow-up period.; Secondary Objective: 2. To establish the acceptability (to patients and clinicians) of computerised CBT. 3. To establish the differential clinical and cost effectiveness of a free-to-use computerised package, in comparison to a commercial pay-to-use computerised CBT package over a two year and longer-term time horizon. ;Primary end point(s): Our primary outcome will be depression severity and symptomatology as measured by a validated self-report measure (the Patient Health Questionnaire-9) and a self-report computer-administered diagnostic interview (CIS-R) at four months. | — |
Countries
United Kingdom
Outcome results
None listed