NCT01151982

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,326

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

1.8 years

First QC Date

June 25, 2010

Last Update Submit

November 17, 2014

Conditions

Depression

Keywords

DepressionPrimary prevention.Primary health care.Randomised controlled trial.

Outcome Measures

Primary Outcomes (1)

  • Accumulated incidence of major depression

    18 months

Secondary Outcomes (1)

  • Cost-effectiveness and cost-utility

    18 months

Study Arms (2)

Psychosocial Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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

Interventions

Psychosocial InterventionBEHAVIORAL

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.

Psychosocial Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients among those attending to primary care centers.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Servicio Andaluz de Salud. Distrito Sanitario Málaga

Málaga, Málaga, 29009, Spain

Location

Unknown Facility

Málaga, Málaga, Spain

Location

Related Publications (3)

  • Fernandez A, Mendive JM, Conejo-Ceron S, Moreno-Peral P, King M, Nazareth I, Martin-Perez C, Fernandez-Alonso C, Rodriguez-Bayon A, Aiarzaguena JM, Monton-Franco C, Serrano-Blanco A, Ibanez-Casas I, Rodriguez-Sanchez E, Salvador-Carulla L, Garay PB, Ballesta-Rodriguez MI, LaFuente P, Del Mar Munoz-Garcia M, Minguez-Gonzalo P, Araujo L, Palao D, Gomez MC, Zubiaga F, Navas-Campana D, Aranda-Regules JM, Rodriguez-Morejon A, de Dios Luna J, Bellon JA. A personalized intervention to prevent depression in primary care: cost-effectiveness study nested into a clustered randomized trial. BMC Med. 2018 Feb 23;16(1):28. doi: 10.1186/s12916-018-1005-y.

    PMID: 29471877DERIVED

  • Bellon JA, Conejo-Ceron S, Moreno-Peral P, King M, Nazareth I, Martin-Perez C, Fernandez-Alonso C, Rodriguez-Bayon A, Fernandez A, Aiarzaguena JM, Monton-Franco C, Ibanez-Casas I, Rodriguez-Sanchez E, Ballesta-Rodriguez MI, Serrano-Blanco A, Gomez MC, LaFuente P, Munoz-Garcia Mdel M, Minguez-Gonzalo P, Araujo L, Palao D, Bully P, Zubiaga F, Navas-Campana D, Mendive J, Aranda-Regules JM, Rodriguez-Morejon A, Salvador-Carulla L, de Dios Luna J. Intervention to Prevent Major Depression in Primary Care: A Cluster Randomized Trial. Ann Intern Med. 2016 May 17;164(10):656-65. doi: 10.7326/M14-2653. Epub 2016 Mar 29.

    PMID: 27019334DERIVED

  • Bellon JA, Conejo-Ceron S, Moreno-Peral P, King M, Nazareth I, Martin-Perez C, Fernandez-Alonso C, Ballesta-Rodriguez MI, Fernandez A, Aiarzaguena JM, Monton-Franco C, Ibanez-Casas I, Rodriguez-Sanchez E, Rodriguez-Bayon A, Serrano-Blanco A, Gomez MC, LaFuente P, Del Mar Munoz-Garcia M, Minguez-Gonzalo P, Araujo L, Palao D, Espinosa-Cifuentes M, Zubiaga F, Navas-Campana D, Mendive J, Aranda-Regules JM, Rodriguez-Morejon A, Salvador-Carulla L, de Dios Luna J. Preventing the onset of major depression based on the level and profile of risk of primary care attendees: protocol of a cluster randomised trial (the predictD-CCRT study). BMC Psychiatry. 2013 Jun 19;13:171. doi: 10.1186/1471-244X-13-171.

    PMID: 23782553DERIVED

MeSH Terms

Conditions

Depression

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Medicine

Study Record Dates

First Submitted

June 25, 2010

First Posted

June 29, 2010

Study Start

October 1, 2010

Primary Completion

July 1, 2012

Study Completion

January 1, 2013

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

ES(2)