Comparing Engage to PST for Late Life Depression (Engage)
Stepped, Reward-exposure Based Therapy vs. PST in Late Life Depression
調査の概要
詳細な説明
Policy reports document that evidence-based psychotherapies are rarely employed and sustained in the community. Several causes of this science to service gap have been identified. One cause, specific to behavioral interventions, is the complexity of interventions and the competencies community clinicians must acquire and sustain over time in order to deliver them. A realistic solution is to streamline behavioral interventions and tailor them to the settings and therapist skill level available in the community. In response to this need, we have developed Engage, which: 1) is streamlined on the basis of concepts and findings on the neurobiology of depression; 2) consists of psychotherapeutic and ecosystem management components of known efficacy; 3) has distilled and simplified these components so as they can be accessible to most depressed older patients and taught to larger numbers of clinicians than available therapies, e.g., Problem Solving Therapy (PST); and 4) is personalized through a structured stepped approach focusing on "reward exposure". Problem Solving Therapy is an evidenced-based intervention shown to be effective in treating late-life depression.
Three hundred (150 per site) patient participants will be randomly assigned to receive 9 sessions of either Engage or PST. Forty-two clinician participants will be randomly assigned to receive training and certification in either Engage or PST. Once certified, clinicians will be assigned a patient participant and administer their assigned intervention.
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
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New York
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White Plains、New York、アメリカ、10605
- Weill Medical College of Cornell University
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Washington
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Seattle、Washington、アメリカ、98195
- University of Washington Department of Psychiatry and Behavioral Sciences
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参加基準
適格基準
就学可能な年齢
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 (Patient participants):
- Age ≥ 60 years
- unipolar, non-psychotic major depression (by SCID, DSM-IV)
- MADRS ≥ 20
- MMSE ≥ 24
- off antidepressants or have been on a stable dose of an antidepressant for 12 weeks and do not intend to change the dose in the next 10 weeks
- English speaking
- capacity to provide written consent
Exclusion Criteria (Patient participants):
- Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or generalized anxiety disorder
- Newly started use of psychotropic drugs (<12wks) or cholinesterase inhibitors other than mild doses of benzodiazepines
- Current active suicidal intent/plan
- Current substance abuse
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：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Problem Solving Therapy
Problem solving therapy is an evidence based psychotherapy for depression, with 30 years of research supporting its efficacy.
PST focuses on the patients themselves and helps them develop skills in identifying, prioritizing, and solving problems, and thereby creates a sense of empowerment.
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PST is a behavioral intervention for depression that is delivered by trained therapists over a 9 week period.
It consists of a process to help patients understand and then solve the problems in their lives they feel is contributing to their depression.
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実験的：Engage
Engage utilizes reward exposure consisting of the reintroduction of activities that patients once found rewarding and enjoyed, but have abandoned after they developed depression.
Engage uses basic problem solving through which patients learn how to form "action plans" for pursuing rewarding activities of their choice.
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Engage is a weekly behavioral intervention that is delivered over a 9 week period of time by trained therapists.
The focus of Engage is to help patient reconnect with activities that they have lost interest in pursuing due to depression.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Depression
時間枠：Measured at pretreatment and weeks 2,4,6,8,9,26 and 36
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Depression will be assessed using the Hamilton Depression Rating Scale, a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
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Measured at pretreatment and weeks 2,4,6,8,9,26 and 36
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協力者と研究者
スポンサー
捜査官
- 主任研究者：George Alexopoulos, M.D.、Weill Medical College of Cornell University
- 主任研究者：Patricia Arean, PhD、UW
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。
Problem Solving Therapyの臨床試験
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Universitätsklinikum Hamburg-EppendorfCytoSorbents, Inc募集
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Universitätsklinikum Hamburg-Eppendorf完了
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George Washington UniversityTranscultural Psychosocial Organization Nepal完了