Primary Prevention of Major Depression Based on the Level and Profile of Risk of Primary Care Attenders: Cluster, Controlled, Randomised Trial (predictD-CCRT)
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Málaga, 스페인
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Málaga, 스페인, 29009
- Servicio Andaluz de Salud. Distrito Sanitario Málaga
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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. |
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. |
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간섭 없음: Usual Care
The kind of care that general practitioners usually provide when not knowing the level and risk profile of depression of the patients
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Accumulated incidence of major depression
기간: 18 months
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18 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Cost-effectiveness and cost-utility
기간: 18 months
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To evaluate the cost-effectiveness and cost-utility of the intervention versus usual care.
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18 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PS09/00081
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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