ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01151982
Recruitment Status : Completed
First Posted : June 29, 2010
Last Update Posted : November 19, 2014
Sponsor:
Collaborators:
Preventive Services and Health Promotion Research Network
Carlos III Health Institute
Andaluz Health Service
Information provided by (Responsible Party):
Juan Ángel Bellón Saameño, The Mediterranean Institute for the Advance of Biotechnology and Health Research

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : October 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Accumulated incidence of major depression [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Cost-effectiveness and cost-utility [ Time Frame: 18 months ]
    To evaluate the cost-effectiveness and cost-utility of the intervention versus usual care.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151982


Locations
Spain
Servicio Andaluz de Salud. Distrito Sanitario Málaga
Málaga, Spain, 29009
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Juan Ángel Bellón Saameño, PhD Medicine, The Mediterranean Institute for the Advance of Biotechnology and Health Research
ClinicalTrials.gov Identifier: NCT01151982     History of Changes
Other Study ID Numbers: PS09/00081
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by Juan Ángel Bellón Saameño, The Mediterranean Institute for the Advance of Biotechnology and Health Research:
Depression
Primary prevention.
Primary health care.
Randomised controlled trial.

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders