Evaluating a Behavioral Activities Treatment Program for Depressed Nursing Home Residents (BE-ACTIV)
BE-ACTIV: Treating Depression in Nursing Homes
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Kentucky
-
Louisville、Kentucky、アメリカ、40292
- University of Louisville
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:A
Participants will receive the BE-ACTIV treatment
|
BE-ACTIV is 10-week behavioral treatment involving increasing pleasant events.
|
|
アクティブコンパレータ:B
Participants will receive treatment as usual
|
TAU includes usual treatment in nursing care facility.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Depression diagnosis and depressive symptoms as assessed by the Geriatric Depression Scale
時間枠: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
時間枠:Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Staff attention
時間枠:Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Positive affect
時間枠:Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Activity participation
時間枠:Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Behavior problems
時間枠:Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Resident satisfaction
時間枠:Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Suzanne Meeks, PhD、University of Louisville
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
BE-ACTIVの臨床試験
-
Maastricht University Medical CenterB. Braun/Aesculap Spine完了
-
Ankara Yildirim Beyazıt UniversityAnkara Training and Research Hospital募集
-
Be Biopharma終了しました
-
KU LeuvenFlemish Agency for Care and Health完了
-
Salts Healthcare募集