Patient-reported outcome measures for monitoring primary care patients with depression: PROMDEP randomised controlled trial
- Conditions
- DepressionMental and Behavioural Disorders
- Registration Number
- ISRCTN17299295
- Lead Sponsor
- niversity of Southampton
- Brief Summary
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32471492/ protocol (added 01/06/2020) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38551155/ (added 03/04/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 529
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptoms of depression measured using the Beck Depression Inventory second edition BDI-II (36) at baseline and 12 weeks
- Secondary Outcome Measures
Name Time Method 1. Symptoms of depression measured on the Beck Depression Inventory second edition BDI-II at 26 weeks<br>2. Social functioning measured using the Work & Social Adjustment Scale at baseline, 12 weeks and 26 weeks<br>3. Quality of life measured using the EuroQol 5-item 5-level (EQ-5D) questionnaire at baseline, 12 weeks, and 26 weeks<br>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<br>5. Patient satisfaction measured using a modified version of the Medical Informant Satisfaction Scale at 26 weeks