Perinatal Depression Treatment in a Pediatric Setting- Pilot Phase (MITT)
Adapting Collaborative Care Perinatal Depression Treatment to a Pediatric Setting - Pilot Phase
調査の概要
詳細な説明
This research project consists of two phases that are designed, in sequence, to adapt standard collaborative care depression treatment to the unique needs of low-income depressed postpartum women and to the pediatric setting where women will receive the treatment. These adaptations, in turn, are designed to improve maternal engagement in and adherence to depression treatment, the primary outcomes at this early stage of intervention development. Phase I is the initial pilot project in which the model will be developed. We will 1) adapt standard collaborative care depression models into the Mother-Infant Treatment Team (MITT) intervention and develop a procedure manual based on maternal and provider input, 2) pilot the MITT intervention with 10 depressed mothers to test the feasibility of implementing the model, and 3) evaluate the experiences of participating mothers and providers to revise and finalize MITT processes and procedures.
Phase II will be an open label trial of MITT to determine whether MITT is associated with improved maternal engagement and adherence to depression treatment.
We will pilot MITT with 10 mothers to determine the feasibility of implementing MITT. We will collect recruitment and logistical feasibility measures. We will also determine engagement and adherence rates to treatment as well as the effort required to engage women in treatment.
We will determine mothers' and providers' perceptions of their experiences with MITT and will use all of this information to revise the MITT protocol in preparation for Phase II.
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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Rochester、New York、アメリカ、14642
- University of Rochester
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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:
- Mothers of infants 12 months of age or younger who present to the Pediatric Practice at Golisano Children's Hospital
- Women who are 18 years of age or older
- Mothers who understand and speak English sufficiently to participate in therapy with an English speaking provider
- Have a current score of > 10 on the EPDS
- Provide written informed consent
- Meet criteria for unipolar major depressive disorder.
Exclusion Criteria:
Women who:
- do not speak or understand English well enough to participate in the therapy with an English speaking provider
- are under 18 years of age
- children are not cared for at the Pediatric Practice at the Golisano Children's Hospital
- are actively psychotic, suicidal or homicidal,
- require treatment (including additional psychotropic medications) not provided by MITT,
- in the judgment of the MITT psychiatric provider require a higher level of psychiatric care (i.e. partial hospitalization, hospitalization, intensive case management),
- are in active counseling or psychotherapy,
- are under the care of a psychiatric provider and/or are receiving active treatment for depression including light therapy, ECT, or antidepressants
- are receiving psychotropic medications not allowed in this study,
- previously participated in and/or were terminated from the study,
- have a diagnosis of bipolar disorder, schizophrenia, other psychotic disorder or alcohol/substance use disorder, and/or
- have a medical condition or are taking medications that are contraindicated for sertraline
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：ヘルスサービス研究
- 割り当て：なし
- 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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実験的：MITT
Mothers will be assigned to the Mother-Infant Treatment Team (MITT)and will receive either psychotherapy or sertraline or both as well as outreach.
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This is a treatment team approach that allows for outreach.
The clinical team will be a nurse practitioner of psychiatry and a social worker.
The nurse practitioner will provide either interpersonal psychotherapy, sertraline or both as indicated.
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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 |
時間枠 |
|---|---|
|
Treatment Engagement
時間枠：6 weeks
|
6 weeks
|
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Treatment Adherence
時間枠：18 weeks
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18 weeks
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Treatment Response
時間枠：12 weeks
|
12 weeks
|
|
Treatment Remission
時間枠：12 weeks
|
12 weeks
|
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Maternal functional assessment
時間枠：12 weeks
|
12 weeks
|
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Maternal healthcare utilization
時間枠：18 weeks
|
18 weeks
|
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Infant healthcare utilization
時間枠：18 weeks
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18 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Linda H Chaudron, MD, MS、University of Rochester
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 (見積もり)
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。