- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00536406
Evaluating a Behavioral Activities Treatment Program for Depressed Nursing Home Residents (BE-ACTIV)
BE-ACTIV: Treating Depression in Nursing Homes
연구 개요
상세 설명
Depression is a common mental disorder that affects nearly half of all older people living in nursing homes. Depression can severely impact people's lives, causing them to often feel sad and hopeless, as well as affect people's sleep patterns, concentration, and energy levels. In addition, nursing homes are often understaffed and very busy, making it difficult for older people with depression to receive a proper diagnosis and adequate treatment. Recent studies have shown that an increase in pleasurable activities among residents in nursing homes can improve symptoms of depression. The purpose of this study is to determine whether symptoms of depression can be reduced by increasing opportunities for nursing home residents to engage in pleasant events and build better relationships with nursing home staff members.
Participating nursing homes will be randomly assigned to have their residents receive behavioral activity treatment (BE-ACTIV) or treatment as usual for 12 weeks. Potential participating nursing home residents will complete two brief tests regarding memory, attention, and symptoms of depression. An hour-long interview will then be conducted during which eligible participating residents will discuss their symptoms of depression, rate their health and level of functioning, and assess the quality of their relationship with a staff member. Residents receiving BE-ACTIV will meet with a therapist for weekly 30-minute sessions for 10 weeks. During these sessions, residents will discuss their activity participation and any pleasant events that they recently experienced. Therapists and nursing home activities staff will work together to incorporate more activities of interest into each resident's schedule. Residents of nursing homes assigned to receive treatment as usual will be asked to rate their mood once a week for 10 weeks. Researchers will observe each resident, regardless of treatment group, for 5-minute intervals at various times during the study to assess mood and activity levels. All participating residents will undergo a second interview after 10 weeks to discuss any changes or improvements in mood, symptoms of depression, activity level, or their relationship with staff members. All participating residents will be assessed after 3 months and again after 6 months post-treatment to determine whether the BE-ACTIV program was successful in improving symptoms of depression.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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Kentucky
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Louisville, Kentucky, 미국, 40292
- University of Louisville
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Nursing home residents in long-term care beds with an expected stay of 3 months or more
- Geriatric Depression Scale score of at least 11
- Meets DSM-IV criteria for major depressive disorder or research diagnostic criteria for minor depressive disorder
Exclusion Criteria:
- Mini Mental State Exam score below 14
- Referred to hospice care for a terminal condition
- Current unstable or terminal medical condition
- Suicidal
- Meets DSM-IV criteria for bipolar disorder
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: A
Participants will receive the BE-ACTIV treatment
|
BE-ACTIV is 10-week behavioral treatment involving increasing pleasant events.
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활성 비교기: B
Participants will receive treatment as usual
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TAU includes usual treatment in nursing care facility.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Depression diagnosis and depressive symptoms as assessed by the Geriatric Depression Scale
기간: Measured at Weeks 12, 24, and 48
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Measured at Weeks 12, 24, and 48
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Functioning as assessed by the Dartmouth COOP Scales for Social Functioning
기간: Measured at Weeks 12, 24, and 48
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Measured at Weeks 12, 24, and 48
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Staff attention
기간: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
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Positive affect
기간: Measured at Weeks 12, 24, and 48
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Measured at Weeks 12, 24, and 48
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Activity participation
기간: Measured at Weeks 12, 24, and 48
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Measured at Weeks 12, 24, and 48
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Behavior problems
기간: Measured at Weeks 12, 24, and 48
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Measured at Weeks 12, 24, and 48
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Resident satisfaction
기간: Measured at Weeks 12, 24, and 48
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Measured at Weeks 12, 24, and 48
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공동 작업자 및 조사자
수사관
- 수석 연구원: Suzanne Meeks, PhD, University of Louisville
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
BE-ACTIV에 대한 임상 시험
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Maastricht University Medical CenterB. Braun/Aesculap Spine완전한
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Ankara Yildirim Beyazıt UniversityAnkara Training and Research Hospital모병
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KeifeRx, LLCWorldwide Clinical Trials; Life Molecular Imaging GmbH; Sun Pharmaceuticals Industries Limited아직 모집하지 않음
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KU LeuvenFlemish Agency for Care and Health모병
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Aurora Health CareAurora BayCare Medical Center; BayCare Health System완전한
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Great Ormond Street Hospital for Children NHS Foundation...Medical Research Council; UCL Great Ormond Street Institute of Child Health모병
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Universite du Quebec en OutaouaisCanadian Institutes of Health Research (CIHR); University College, London; Concordia University...완전한