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

Sponsor

The Mediterranean Institute for the Advance of Biotechnology and Health Research (Other)

Overall Status

Completed

CT.gov ID

NCT01151982

Collaborator

Preventive Services and Health Promotion Research Network (Other), Carlos III Health Institute (Other), Andaluz Health Service (Other)

3,326

Enrollment

Locations

Arms

Duration (Months)

1663

Patients Per Site

61.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Psychosocial Intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

3326 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
No Intervention: Usual Care The kind of care that general practitioners usually provide when not knowing the level and risk profile of depression of the patients

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: Psychosocial Intervention

No Intervention: Usual Care

The kind of care that general practitioners usually provide when not knowing the level and risk profile of depression of the patients

Outcome Measures

Primary Outcome Measures

Accumulated incidence of major depression [18 months]

Secondary Outcome Measures

Cost-effectiveness and cost-utility [18 months]
To evaluate the cost-effectiveness and cost-utility of the intervention versus usual care.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Servicio Andaluz de Salud. Distrito Sanitario Málaga	Málaga		Spain	29009
2		Málaga		Spain

Sponsors and Collaborators

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