Depression Mental and Behavioural Disorders
Conditions
Interventions
Design: Parallel group cluster randomised trial with 1:1 allocation to intervention and control.
Intervention: Administration of PHQ-9 soon after diagnosis, and at follow-up 10-35 days later. GP ref
SD 10.0 (from feasibility RCT)
follow-up mean of 14.0 at 12 weeks in intervention group, 17.0 in controls (difference 3.0 = effect size of 0.3 and MCID of 17.5% of control group score)
mean 6 patients per practice
ICC 0.03
5% significance
90% power
needs 235 patients analysed per group. Cluster design effect 1.15
assuming 20% loss to follow-up gives 235x1.15x2/0.8 =676 total, from 113 practices across three centres.
Randomisation: by Clinical Trial Unit statistician with computerised sequence generation.
Bli
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1, Adult patients seen in participating general practices within the last two weeks and assigned Read computerised medical record codes by GPs or nurse practitioners (NPs) for new presentations with diagnoses or symptoms of depression 2. There will be no upper age limit, and no exclusion of patients with coexisting physical health problems
Exclusion criteria
Exclusion criteria: 1. Patients will be excluded if they are already being treated for depression, or if they have comorbid dementia, psychosis, or substance misuse (as a main problem) 2. Patients will also be excluded if they have significant suicidal thoughts requiring possible urgent referral to specialist mental health care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms of depression measured using the Beck Depression Inventory second edition BDI-II (36) at baseline and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptoms of depression measured on the Beck Depression Inventory second edition BDI-II at 26 weeks 2. Social functioning measured using the Work & Social Adjustment Scale at baseline, 12 weeks and 26 weeks 3. Quality of life measured using the EuroQol 5-item 5-level (EQ-5D) questionnaire at baseline, 12 weeks, and 26 weeks 4. Costs of consultations, drug treatments and referrals for depression over the six months trial period, measured using a patient questionnaire (modified Client Services Receipt Inventory) combined with a medical notes review at 26 weeks 5. Patient satisfaction measured using a modified version of the Medical Informant Satisfaction Scale at 26 weeks | — |
Countries
England, United Kingdom
Outcome results
None listed