- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00536406
Evaluating a Behavioral Activities Treatment Program for Depressed Nursing Home Residents (BE-ACTIV)
BE-ACTIV: Treating Depression in Nursing Homes
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Kentucky
-
Louisville, Kentucky, États-Unis, 40292
- University of Louisville
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: A
Participants will receive the BE-ACTIV treatment
|
BE-ACTIV is 10-week behavioral treatment involving increasing pleasant events.
|
|
Comparateur actif: B
Participants will receive treatment as usual
|
TAU includes usual treatment in nursing care facility.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Depression diagnosis and depressive symptoms as assessed by the Geriatric Depression Scale
Délai: 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
Délai: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Staff attention
Délai: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Positive affect
Délai: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Activity participation
Délai: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Behavior problems
Délai: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Resident satisfaction
Délai: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Suzanne Meeks, PhD, University of Louisville
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R01MH074865 (Subvention/contrat des NIH des États-Unis)
- DATR A4-GPS
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