- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00536406
Evaluating a Behavioral Activities Treatment Program for Depressed Nursing Home Residents (BE-ACTIV)
BE-ACTIV: Treating Depression in Nursing Homes
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Kentucky
-
Louisville, Kentucky, Forenede Stater, 40292
- University of Louisville
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: A
Participants will receive the BE-ACTIV treatment
|
BE-ACTIV is 10-week behavioral treatment involving increasing pleasant events.
|
Aktiv komparator: B
Participants will receive treatment as usual
|
TAU includes usual treatment in nursing care facility.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Depression diagnosis and depressive symptoms as assessed by the Geriatric Depression Scale
Tidsramme: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Functioning as assessed by the Dartmouth COOP Scales for Social Functioning
Tidsramme: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Staff attention
Tidsramme: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Positive affect
Tidsramme: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Activity participation
Tidsramme: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Behavior problems
Tidsramme: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Resident satisfaction
Tidsramme: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Suzanne Meeks, PhD, University of Louisville
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01MH074865 (U.S. NIH-bevilling/kontrakt)
- DATR A4-GPS
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Depression
-
ProgenaBiomeRekrutteringDepression | Depression, postpartum | Depression, angst | Depression Moderat | Depression Alvorlig | Klinisk depression | Depression i remission | Depression, Endogen | Depression KroniskForenede Stater
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRekrutteringDepression | Depression Moderat | Depression Alvorlig | Depression MildForenede Stater
-
University of California, San FranciscoRekrutteringDepression Moderat | Depression Mild | Depression, teenagerForenede Stater
-
Washington University School of MedicineAfsluttetBehandlingsresistent depression | Senlivsdepression | Geriatrisk depression | Refraktær depression | Terapi-resistent depressionForenede Stater, Canada
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RekrutteringDepression Moderat | Depression Alvorlig | Depression MildBelgien
-
Baylor College of MedicineUniversity of TexasRekrutteringDepression | Depression Moderat | Depression Alvorlig | Selvmord og selvskade | Depression i ungdomsårene | Depression MildForenede Stater
-
Charite University, Berlin, GermanyAfsluttetBehandlingsresistent depression | Depression, Unipolar | Depression KroniskTyskland
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoAfsluttetDepression Moderat | Depression MildForenede Stater, Dominikanske republik
-
Federal Research Center of Fundamental and Translational...AfsluttetDepression Moderat | Depression MildDen Russiske Føderation
-
Ludwig-Maximilians - University of MunichAfsluttetTerapi-resistent svær depressionTyskland
Kliniske forsøg med BE-ACTIV
-
Universidad Complutense de MadridUkendtAtletisk præstationSpanien
-
Ankara Yildirim Beyazıt UniversityAnkara Training and Research HospitalRekruttering
-
Maastricht University Medical CenterB. Braun/Aesculap SpineAfsluttetIntervertebral diskforskydning | DiskektomiHolland
-
Baskent UniversityHacettepe UniversityAfsluttetMotionstræning | Fysioterapi | Energimetabolisme | AmputeredeKalkun
-
KeifeRx, LLCWorldwide Clinical Trials; Life Molecular Imaging GmbH; Sun Pharmaceuticals...Ikke rekrutterer endnu
-
NORCE Norwegian Research Centre ASUniversity of Tromso; Bjørnafjorden municipality; Narvik municipalityRekruttering
-
KU LeuvenFlemish Agency for Care and HealthRekrutteringÆldre mennesker | Implementering | Forebyggelse af faldBelgien
-
University of AlbertaUniversity of CalgaryAktiv, ikke rekrutterendePostoperative komplikationer | Kirurgi | MobilitetCanada
-
Great Ormond Street Hospital for Children NHS Foundation...Medical Research Council; UCL Great Ormond Street Institute of Child HealthRekrutteringRecidiverende/refraktær T-celle Akut lymfoid leukæmiDet Forenede Kongerige
-
Universite du Quebec en OutaouaisCanadian Institutes of Health Research (CIHR); University College, London; Concordia University, MontrealAfsluttet