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Cluster randomized clinical trial to evaluate the effectiveness of a diagnosis recognition and treatment guide for depressive disorders in primary care

Cluster randomized clinical trial to evaluate the effectiveness of a diagnosis recognition and treatment guide for depressive disorders in primary care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN23732000
Enrollment
240
Registered
2007-09-28
Start date
2003-06-16
Completion date
Unknown
Last updated
2020-11-02

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

Conditions

Depression Mental and Behavioural Disorders Depression

Interventions

There were 4 control clusters and 4 intervention clusters. Each cluster had 8 participating clinicians and 30 participating patients (8 clinicians and 240 patients in total). All pati

Sponsors

Federal University of Sao Paulo (Brazil)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Clinicians: All general clinicians working at the basic healthcare units of primary care setting were eligible to participate in the study regardless of age, gender, year of graduation and activity in primary care. Patients: 1. Patients living within the geographical area of the clinician 2. Aged more than 18 years 3. Both gender 4. Clinical diagnosis of depression according to the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria and with a baseline score of 8 to 22 points in the Hamilton Rating Scale for Depression (HAM-D)

Exclusion criteria

Exclusion criteria: Clinicians: 1. Refused to participate in the study 2. Where there were two clinicians working at the same practice, one of them was excluded to avoid the risk of cross contamination Patients: 1. Already using antidepressant 2. Psychiatric co-morbidity and/or a severe medical condition

Design outcomes

Primary

MeasureTime frame
At 16 weeks, depression severity as measured by the HAM-D scale, was evaluated at a mental health facility by two independent evaluators who were blind to treatment allocation. Differences in score were resolved by consensus between evaluators. The primary outcomes were: 1. Appropriate treatment rate, through the prescription of an antidepressant at the first appointment with the clinician 2. Clinical remission rate (16 week depression severity of less than 8 points on the HAM-D scale)

Secondary

MeasureTime frame
1. Cost of treatment during the 16 weeks of follow-up was calculated in US dollars using the lowest posted January 2007 price of medications (www.consultaremedios.com.br). 2. Withdrawals in the two treatment groups were compared. Patients refusing treatment after referral to the primary care clinician or not attending the three consecutive appointments were defined as patient withdrawals. Patients whose depression worsened and were referred for an urgent or emergency psychiatric assessment were withdrawn by the primary care clinician and referred to treatment in secondary mental health facility.

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026