ASHA バングラデシュ -- 貧困とうつ病に対処するための統合的介入
2026年6月11日 更新者：Alison Karasz、University of Massachusetts, Worcester
ASHAバングラデシュ -- 低所得の農村部女性のうつ病に対処するための統合的介入
このランダム化対照試験の目的は、バングラデシュの農村部の低所得のうつ病患者女性を対象に、貧困緩和とうつ病治療を組み合わせた統合的介入の効果をうつ病治療単独と比較することである。
この研究が答えようとしている主な疑問は次のとおりである。1) 統合的介入によるうつ病治療に貧困緩和を追加すると、うつ病の症状と再発の有無によって評価して、24か月時点でのうつ病の転帰が改善するかどうか。 2) うつ病の治療に貧困緩和を追加すると、治療の受け入れと定着を含む実施結果が改善されるかどうか。
両群の参加者は、6、12、18、24 か月目に面接に参加します。
調査の概要
研究の種類
介入
入学 (推定)
600
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Alison Karasz, PhD
- 電話番号：3478435652
- メール：alison.karasz@umassmed.edu
研究場所
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Dhaka Division
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Dhaka、Dhaka Division、バングラデシュ
- 募集
- International Centre for Diarrhoeal Disease Research
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コンタクト：
- Fahmida Tofail, MBBS, PhD
- メール：ftofail@icddrb.org
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- 既婚女性。
- 18～75歳。
- ベンガル語に堪能）。
- 経済脆弱性指数の基準を満たしています
- 患者健康アンケートで 10 以上 (ベースラインでの PHQ-9 うつ病スケール)
除外基準:
- インフォームドコンセントを提供できない。
- 2,400 万期間中に 1 か月以上の旅行を計画している。
- その他の理由により研究に参加できない場合
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：トリプル
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：うつ病治療 (DT)
対照群の参加者は以下を受け取ります：1）6回の手順化されたグループ心理療法治療。
この治療はWHOのプログラム「問題管理プラス（PM+）」に基づいて適応されています。
PM+には4つのエビデンスに基づく戦略が含まれます：問題解決、社会的支援の強化、行動活性化、深呼吸によるリラクゼーション。2）4回のサポートグループミーティング。
この介入は、訓練を受けた非専門家のピアによって提供されます。
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対照群の参加者は、10回セッション・6か月間のマニュアル化されたグループベースの心理療法治療を受けます。
この治療は、世界保健機関（WHO）の「問題管理プラス（PM+）」と呼ばれるプログラムから適応されています。
PM+には、以下の4つのエビデンスに基づく戦略が含まれています：1）問題解決；2）社会的支援の強化；3）行動活性化；4）深呼吸によるリラクゼーション。
この介入は、訓練を受けた非専門家のピアによって実施されます。
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実験的：統合介入
実験群には2つの要素が含まれます：
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対照群の参加者は、10回セッション・6か月間のマニュアル化されたグループベースの心理療法治療を受けます。
この治療は、世界保健機関（WHO）の「問題管理プラス（PM+）」と呼ばれるプログラムから適応されています。
PM+には、以下の4つのエビデンスに基づく戦略が含まれています：1）問題解決；2）社会的支援の強化；3）行動活性化；4）深呼吸によるリラクゼーション。
この介入は、訓練を受けた非専門家のピアによって実施されます。
上記の心理療法介入に加えて、実験群の参加者は、低所得国で広く使用されている貧困削減介入である有名な卒業プログラムから適応した貧困削減介入を受けます。
貧困削減介入には、a) 4回の金融リテラシー教育セッション、b) 貯蓄口座、c) 6ヶ月間1日あたり1kgの米の費用に相当する消費支援、d) 3頭のヤギの生産的資産移転、e) 12ヶ月間の動物飼料と獣医療、f) 園芸用品、g) 農業スキル構築が含まれます。
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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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6か月での抑うつ症状の変化
時間枠：6ヶ月
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患者の健康アンケートで測定されたベースライン後のベースラインから6か月の症状の変化は、抑うつ症状を評価するために設計された9項目のアンケートです。
最小スコアは0です。最大スコアは27です。
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6ヶ月
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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18カ月後の再発
時間枠：18ヶ月
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再発は、時点2（6ヶ月）で寛解を達成した参加者のうち、患者健康アンケートのスコアが5以上であることと定義されます。
再発を評価するため、各データ収集時点（6、12、18ヶ月）において、研究者は前回のデータ収集時点以降に抑うつ症状を経験したかどうかを参加者に質問します。
データ収集は、18ヶ月時点での再発、または時点2以降のいずれかの時点での再発の有無に焦点を当てます。
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18ヶ月
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12ヶ月および18ヶ月時点のうつ病
時間枠：12ヵ月および18ヵ月
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他の時点におけるPHQ-9とベースラインの変化：12か月および18か月
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12ヵ月および18ヵ月
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経済的脆弱性指数
時間枠：ベースライン、12か月、18か月
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収入、債務、食料不安など様々な指標を含む経済的脆弱性の複合指数。
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ベースライン、12か月、18か月
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不安
時間枠：ベースライン、6か月、12か月、18か月
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全般性不安障害尺度で測定される不安症状 - 0から21のスコアを持つ7項目の質問票。
スコアが高いほど不安が強いことを示します。
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ベースライン、6か月、12か月、18か月
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機能
時間枠：ベースライン、6ヶ月、12ヶ月、18ヶ月
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世界保健機関障害評価スケール（WHO-DAS）を用いて測定される機能と障害。これは12項目の質問票であり、12～60点で採点され、高いスコアはより重度の障害を示します。
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ベースライン、6ヶ月、12ヶ月、18ヶ月
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生活の質の変化
時間枠：ベースライン、6ヵ月、12ヵ月、および18ヵ月
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5つの次元（移動能力、セルフケア、通常の活動、痛み・不快感、不安・抑うつ）を含む生活の質尺度。スコアは0〜100で、スコアが高いほど生活の質が高いことを示します。
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ベースライン、6ヵ月、12ヵ月、および18ヵ月
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緊張スケール
時間枠：ベースライン、6ヶ月、12ヶ月、18ヶ月
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心理的症状と身体的文化症状の両方を測定するアンケート：39項目の測定尺度で、各項目0-3点で評価し、最低スコア0点、最高スコア117点で、スコアが高いほど苦痛のレベルが高いことを示します。
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ベースライン、6ヶ月、12ヶ月、18ヶ月
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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実装成果--導入
時間枠：ベースライン + 30日
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治療セッションに1回以上参加した参加者数／無作為化された参加者数。
募集および研究記録に基づく。
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ベースライン + 30日
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実施成果--実現可能性
時間枠：6か月
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介入セッションの70％以上（7セッション）に参加した参加者の割合 - 研究記録に基づく。
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6か月
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実施成果--忠実度
時間枠：少なくとも6か月間の治療群ごとに1回。
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セッションのスーパーバイザーによる観察は、準備状態（0-3）、ファシリテーション（0-11）、エンゲージメント（0-6）、時間管理（0-1）、およびドキュメンテーション（0-1）を含むリッカート尺度を使用して忠実度が評価されます。
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少なくとも6か月間の治療群ごとに1回。
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：Alison Karasz, PhD、UMass Chan Medical School
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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主要日程の研究
研究開始 (実際)
2024年3月1日
一次修了 (推定)
2026年12月1日
研究の完了 (推定)
2026年12月1日
試験登録日
最初に提出
2024年2月27日
QC基準を満たした最初の提出物
2024年2月27日
最初の投稿 (実際)
2024年3月6日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月15日
QC基準を満たした最後の更新が送信されました
2026年6月11日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY00001114
- 7R01MH127577 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
私たちは匿名化されたデータセットを作成し、これらのデータに簡単にアクセスして使用できるようにすることを目指しています。
私たちは他の研究者と協力し、追加/二次分析のためにデータを利用できるようにします。
正式なデータ共有契約は、さまざまな目的で提案されたデータセットのさらなるデータマイニングを導き、奨励するために策定されます。
ただし、そのようなデータ要求はすべて、データの倫理的な使用を確保するために、ICDDRB を含む調査チームによって承認されます。
IPD 共有時間枠
データは分析完了後無期限に利用可能になります
IPD 共有アクセス基準
試験用 IPD へのアクセスは、独立した科学研究に従事する資格のある研究者によってリクエストすることができ、研究提案書と統計分析計画 (SAP) の審査と承認、およびデータ共有契約 (DSA) の締結後に提供されます。
IPD 共有サポート情報タイプ
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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。