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

ISRCTN	ISRCTN23732000
DOI	https://doi.org/10.1186/ISRCTN23732000
Protocol serial number	N/A
Sponsor	Federal University of Sao Paulo (Brazil)
Funder	Investigator-funded (Brazil)

Submission date: 17/09/2007
Registration date: 28/09/2007
Last edited: 23/10/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Selma Tsuji
Scientific

Avenida Monte Carmelo
800 - Bairro Fragata
Marília
17519-030
Brazil

Phone	55(14) 34021744
Email	selmart@flash.tv.br

Study information

Primary study design	Interventional
Study design	Multicentric cluster randomized trial.
Secondary study design	Randomised controlled trial
Scientific title	Cluster randomized clinical trial to evaluate the effectiveness of a diagnosis recognition and treatment guide for depressive disorders in primary care
Study objectives	Is the use of a depression recognition and treatment guide by clinicians in a primary care setting effective in the treatment of patients known to have depression? An evaluation of the effectiveness of implementation and dissemination of a guideline for the treatment of depression disorders in primary care.
Ethics approval(s)	1. Research Ethical Committee of Federal University of Sao Paulo (Universidade Federal de Sao Paulo, Escola Paulista de Medicina), Sao Paulo City, State of Sao Paulo, Brazil. Approved on September 4th 2002 (ref: 0588/02) 2. Research Ethical Committee of Faculty of Medicine of Marilia (Faculdade de Medicina de Marilia), Marilia City, State of Sao Paulo, Brazil. Approved on June 24th 2002. 3. Research Ethical Committee of the Primary Care Department of Marilia City (Secretaria Municipal de Higiene e Saude de Marilia) State of Sao Paulo, Brazil. Approved on June 5th 2002.
Health condition(s) or problem(s) studied	Depression
Intervention	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 patients recruited by the principal researcher, after clinical interview and baseline application of HAM-D scale by the research assistant, received a card with their appointment date and the name of primary care clinician that they would be seeing, and an unique patient identifier that would allow the clinician to access the appropriate patient information. Patients were scheduled for follow-up visits to the clinician at 2, 4, 8, 12 and 16 weeks after the fist appointment in primary care. For each patient, a package was sent to the assigned clinician containing the particular diagnosis of depression, the initial patient HAM-D severity score, and a checklist for monitoring patient compliance and response at each visit. The checklist included symptoms of depression, dose and side effects of medications, and treatment compliance. Clinicians in the experimental intervention group also received a depression-specific guide, adopted from rigorous, previously published guidelines, which provided brief and objective educational information regarding the effects of depression on patient's daily living, the importance of recognizing the patient's mental state, the association of the patient's mental state with related signs and symptoms, depression types that can be treated by clinicians, treatment stages, strategies for improving adherence to treatment, and guidelines for the therapeutic management planning using standardized antidepressants in primary care. Clinicians in the intervention group prescribed medications to patients according to the guide for 16 weeks. Control intervention clinicians received patients to treat with usual care.
Intervention type	Other
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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.
Completion date	30/06/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	240
Key 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)
Key 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
Date of first enrolment	16/06/2003
Date of final enrolment	30/06/2006

Locations

Countries of recruitment

Brazil

Study participating centre

Avenida Monte Carmelo

Marília
17519-030
Brazil

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/02/2009	23/10/2020	Yes	No

Editorial Notes

23/10/2020: added pub.