- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00536406
Evaluating a Behavioral Activities Treatment Program for Depressed Nursing Home Residents (BE-ACTIV)
BE-ACTIV: Treating Depression in Nursing Homes
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Kentucky
-
Louisville, Kentucky, Stati Uniti, 40292
- University of Louisville
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: A
Participants will receive the BE-ACTIV treatment
|
BE-ACTIV is 10-week behavioral treatment involving increasing pleasant events.
|
Comparatore attivo: B
Participants will receive treatment as usual
|
TAU includes usual treatment in nursing care facility.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Depression diagnosis and depressive symptoms as assessed by the Geriatric Depression Scale
Lasso di tempo: 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
Lasso di tempo: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Staff attention
Lasso di tempo: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Positive affect
Lasso di tempo: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Activity participation
Lasso di tempo: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Behavior problems
Lasso di tempo: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Resident satisfaction
Lasso di tempo: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Suzanne Meeks, PhD, University of Louisville
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R01MH074865 (Sovvenzione/contratto NIH degli Stati Uniti)
- DATR A4-GPS
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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