Multidisciplinary Model of Nurse Midwife
Multidisciplinary Model of Nurse Midwife Psychotherapy for Postpartum Depression
HYPOTHESES:
The hypotheses are that:
- nurse midwives will be able to safely deliver interpersonal psychotherapy by telephone to women with postpartum depression
- women receiving interpersonal psychotherapy will have less symptoms of postpartum depression, better functioning, better bonding with their babies, and better relationships with their partners
- women with postpartum depression will be more satisfied with their care than women in the group that was referred to a mental health center.
調査の概要
詳細な説明
The specific aims of this pilot non-randomized clinical trial are to evaluate among women with PPD recruited between 6 and 24 weeks postpartum:
- The (a) feasibility, (b) acceptability and (c) safety of a psychological intervention (Interpersonal Psychotherapy [IPT]) provided by nurse midwives in collaboration with a mental health team (psychiatrist team leader and a licensed social worker) for treatment of PPD in a pilot two-armed non-randomized clinical trial.
- The preliminary evidence of efficacy of IPT in decreasing depressive symptoms when administered via telephone by nurse-midwives/ women's health nurse practitioner
The proposed study will also evaluate preliminary evidence for the efficacy of IPT administered by nurse midwives in
- Improving the general level of maternal functioning
- Specific improvement in marital adjustment
- Increase in maternal infant bonding
This pilot study is the first step in developing an intervention to decrease depressive symptoms, improve functioning, improve interpersonal relationships between mother and spouse and infant, improve access to care, and improve treatment engagement among postpartum women diagnosed with PPD. The intervention will be cost-effective, brief and acceptable to both patients and nurse midwives for incorporation into current midwifery practice. If the IPT program is found to be feasible, acceptable and safe with preliminary evidence of efficacy, a postpartum IPT manual for advanced practice nurses will be finalized in order to test whether other advanced practice nurses such as pediatric nurse practitioners and family nurse practitioners can also safely and effectively administer IPT in a full-scale randomized clinical trial
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
-
-
Pennsylvania
-
Phila、Pennsylvania、アメリカ、19102
- Drexel University
-
-
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:
- 6 to 24 weeks postpartum
- 16 years and older
- English-speaking
- Have access to a telephone
- Consents to enter the trial
- Postpartum onset of postpartum depression
- Current use of antidepressant medication as long as dose does not have to be adjusted by subject's healthcare provider during clinical trial
Exclusion Criteria:
- Infant complications requiring medical care beyond 6 weeks postpartum
- Infant birth defects
- Infant being placed for adoption by 6 weeks postpartum
- Maternal mental retardation
- Current use of antidepressant medication that requires dosage adjustment by subject's healthcare provider during clinical trial
- Diagnosis of depression prior to postpartum period
- Active substance or alcohol abuse or dependence
- Active suicidality, homicidality, or current psychosis as assessed by the MINI
- Disabling pain that interferes with the ability to carry out activities of daily living
- Concurrent serious medical co-morbidities (e.g. active lupus, multiple sclerosis, severe cardiac disease severe hypertension, cancer, etc).
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：CNM Interpersonal Psychotherapy
CNM Interpersonal psychotherapy
|
Eight Weekly 50 minute sessions CNM Interpersonal Psychotherapy
|
|
アクティブコンパレータ：Treatment as Usual
Treatment as Usual is psychotherapy with a mental health provider
|
Treatment as Usual is psychotherapy provided by a mental health provider
|
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 |
|---|---|---|
|
Hamilton Rating Scale for depression
時間枠：12 weeks
|
Measure of depression severity
|
12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Global Assessment of functioning
時間枠：12 weeks
|
Measure of functional status
|
12 weeks
|
|
Dyadic Adjustment Scale
時間枠：12 weeks
|
Measure of dyadic adjustment of marital couple
|
12 weeks
|
|
Social Support Questionnaire
時間枠：12 weeks
|
Measure of improvement in social support
|
12 weeks
|
|
Client Satisfaction Questionnaire
時間枠：12 weeks
|
Measure of client satisfaction with midwife counseling
|
12 weeks
|
|
Edinburgh Postnatal Depression Scale
時間枠：12 weeks
|
Measure of severity of postpartum depression
|
12 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Barbara E Posmontier, PHD、Drexel University
- 主任研究者：Richard Neugebauer, PhD、Columbia University
- 主任研究者：Rita Shaughnessy, PhD, MD、Drexel University
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。
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