Depressive disorder Mental and Behavioural Disorders Depression
Conditions
Interventions
Amended as of 08/10/2008:
Experimental Group 1: usual GP care plus "Beating the Blues", a computerised cognitive behavioural therapy package
Experimental Group 2: usual GP care plus "MoodGYM", a free
Sponsors
University of York (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Amended as of 08/10/2008: Adult patients, aged 18 years 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 greater than or equal to 10 on the PHQ9 depression severity instrument. 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. Patients with previous treatment experience of CBT will not be excluded. Initial information at time of registration: Adult patients aged 18 and above with depression who are being considered for anti-depressant drug treatment and for whom computerised therapy represents a non-drug alternative (within a stepped care framework). We will also include patients with either co-morbid physical illness or co-morbid non-psychotic functional disorders, such as anxiety.
Exclusion criteria
Exclusion criteria: Amended as of 08/10/2008: 1. Actively suicidal 2. Suffering psychotic symptoms 3. Depressed in the post-natal period 4. Have recently suffered bereavement 5. 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 Initial information at time of registration: 1. Actively suicidal 2. Suffering psychotic symptoms 3. Depressed in the post-natal period 4. Have recently suffered bereavement 5. Patients already in receipt of anti-depressants 6. Women who are pregnant, or planning to become pregnant (added as of 29/04/2008)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression severity and symptomatology as measured by a validated self-report measure (the Patient Health Questionnaire [PHQ-9]) and the International Classification of Diseases (ICD-10) depression score at four months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PHQ-9 at 12 and 24 months 2. Generic and global mental health (Clinical Outcomes in Routine Evaluation-Outcome Measure [CORE-OM]) at 4, 12 and 24 months 3. Health related quality of life (the Short-Form 36 [SF-36] v2) at 4, 12 and 24 months 4. Health state utility (EuroQol [EQ5D]) at 4, 12 and 24 months | — |
Countries
United Kingdom
Outcome results
None listed