Primary Prevention of Major Depression Based on the Level and Profile of Risk of Primary Care Attenders: Cluster, Controlled, Randomised Trial

Depression Clinical Trial

— predictD-CCRT  

Official title:

Primary Prevention of Major Depression Based on the Level and Profile of Risk of Primary Care Attenders: Cluster, Controlled, Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151982
• Other study ID #: PS09/00081
• Status: Completed
• Phase: N/A
• First received: June 25, 2010
• Last updated: November 17, 2014
• Start date: October 2010
• Est. completion date: January 2013

Study information

• Verified date: November 2014
• Source: The Mediterranean Institute for the Advance of Biotechnology and Health Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

The main objective is to measure the effectiveness of a new intervention for primary prevention of major depression based on the level and profile of risk of primary care attendees. Among the secondary objectives is to evaluate the cost-effectiveness and cost-utility of the intervention versus usual care. METHODS: This is a cluster, randomised controlled trial of a community intervention with cluster at the level of practice. It will be undertaken in primary medical care in 7 Spanish cities and 5 autonomous communities.The aim is to evaluate a new intervention for primary prevention of major depression based on patients' level and profile of risk. Family doctors in the intervention practices will provide the intervention for patients at risk. Patients at risk who are recruited in control practices will receive usual primary care. The main outcome is the accumulated incidence of major depression (measured by CIDI) during the follow-up. The investigators will assess main outcomes and other covariables at baseline, 6, 12, and 18 months. A random sample of 3,381 primary care attendees (1,690 for each arm), aged 18-75 and without major depression will be recruited in 70 health centres (140 family doctors) in 7 cities. The investigators shall undertake a logistic regression multilevel model with 4 levels (time, patient, doctor and health centre). The investigators shall also undertake multivariate gamma and quantile regression to assess respectively the cost-effectiveness and cost-utility of the new intervention versus usual care, estimating their standard errors by bootstrap.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3326
• Est. completion date: January 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients among those attending to primary care centers.

Exclusion Criteria:

• Age under 18 or over 75 years.

• Unable to understand or speak Spanish.

• Represented patients (that is, someone else comes to visit on behalf of the patient).

• Cognitive impairment.

• Psychosis.

• Terminal illness.

• Planning to be outside of the the city during 4 or more months during the next 18 months.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Behavioral:
• Psychosocial Intervention
The intervention we propose to test has 3 actives components. The first one is the fact of giving information to the GPs about the level and risk profile of depression of their patients. The second one is the transmission of this information from the GP to the patient. The third one is the interaction GP/Patient once both have the information about the risk profile of depression and the psychoeducational intervention that the GP will provide to the patient. We will develop psychoeducational booklet, DVDs and websites for patients included in the intervention group. The psychoeducative intervention will be tailored to each patient based on his/her profile, risk level and patients' risk factors. The GPs will receive a 20-hours training course in the intervention. Moreover, we will assume a communitarian view, considering the patient as an active agent for change (empowerment). That is, GPs and patients will work together in order to promote patients' resources.

Locations

Country	Name	City	State
Spain	Servicio Andaluz de Salud. Distrito Sanitario Málaga	Málaga

Sponsors (4)

Lead Sponsor	Collaborator
The Mediterranean Institute for the Advance of Biotechnology and Health Research	Andaluz Health Service, Carlos III Health Institute, Preventive Services and Health Promotion Research Network

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accumulated incidence of major depression		18 months	No
Secondary	Cost-effectiveness and cost-utility	To evaluate the cost-effectiveness and cost-utility of the intervention versus usual care.	18 months	No