Assessment of an enhanced program for depression management in primary care: cluster randomised controlled trial
Not Applicable
Completed
- Conditions
- Moderate to severe, or mild persistent, episode of Major Depression (DSM-IV) who initiate a new antidepressant treatment episode.Mental and Behavioural DisordersDepression
- Registration Number
- ISRCTN16384353
- Lead Sponsor
- Jordi Gol i Gurina Primary Care Research Institute (Institut D'Investigació en Atenció Primària) (IDIAP) (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 396
Inclusion Criteria
1. Primary care patients over 18 years of age
2. An episode of major depression (Diagnostic and Statistical Manual of mental disorders - fourth edition [DSM-IV]), moderate to severe, or persistently mild
3. Who need to initiate anti-depressant treatment
Exclusion Criteria
1. Limitations that prevent the participation (e.g., severe illness, language limitations, etc)
2. Bipolar disorder
3. Psychotic disorder
4. Dependence of alcohol or drugs
5. Pregnancy or lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Severity of the depressive symptoms at three, six and 12 months<br>2. Response rate at three, six and 12 months<br>3. Remission rate (Patient Health Questionnaire [PHQ-9]) at three, six and 12 months
- Secondary Outcome Measures
Name Time Method 1. Health-related quality of life (Short Form health survey [SF-12])<br>2. Satisfaction<br>3. Medical care conformity with clinical guidelines<br>4. Adherence to treatment<br>5. Use of resources<br>6. Costs