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Assessment of an enhanced program for depression management in primary care: cluster randomised controlled trial

Assessment of an enhanced program for depression management in primary care: cluster randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16384353
Enrollment
396
Registered
2007-02-02
Start date
2007-06-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe, or mild persistent, episode of Major Depression (DSM-IV) who initiate a new antidepressant treatment episode. Mental and Behavioural Disorders Depression

Interventions

Two groups, one of which is a control group comprising patients receiving usual primary care management and the other is the intervention group comprising patients on a structured programme for treati
in the continuation phase will be every two months
nevertheless, the plan of follow-up visits will be individualised. The optimal supervision and consultation mechanisms will be implemented with the psychiatric level. Control group: Usual primary ca

Sponsors

Jordi Gol i Gurina Primary Care Research Institute (Institut D'Investigació en Atenció Primària) (IDIAP) (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Severity of the depressive symptoms at three, six and 12 months 2. Response rate at three, six and 12 months 3. Remission rate (Patient Health Questionnaire [PHQ-9]) at three, six and 12 months

Secondary

MeasureTime frame
1. Health-related quality of life (Short Form health survey [SF-12]) 2. Satisfaction 3. Medical care conformity with clinical guidelines 4. Adherence to treatment 5. Use of resources 6. Costs

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 6, 2026