Multidisciplinary Model of Nurse Midwife Psychotherapy for Postpartum Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Hamilton Rating Scale for depression
研究概览
简要总结
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.
详细描述
The specific aims of this pilot non-randomized clinical trial are to evaluate among women with PPD recruited between 6 and 24 weeks postpartum:
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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.
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The preliminary evidence of efficacy of IPT in decreasing depressive symptoms when administered via telephone by nurse-midwives/ women's health nurse practitioner
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The proposed study will also evaluate preliminary evidence for the efficacy of IPT administered by nurse midwives in
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Improving the general level of maternal functioning
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Specific improvement in marital adjustment
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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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
CNM Interpersonal Psychotherapy
CNM Interpersonal psychotherapy
干预措施: CNM Interpersonal Psychotherapy (Behavioral)
Treatment as Usual
Treatment as Usual is psychotherapy with a mental health provider
干预措施: Treatment as Usual (Behavioral)
结局指标
主要结局
Hamilton Rating Scale for depression
时间窗: 12 weeks
Measure of depression severity
次要结局
- Global Assessment of functioning(12 weeks)
- Dyadic Adjustment Scale(12 weeks)
- Social Support Questionnaire(12 weeks)
- Client Satisfaction Questionnaire(12 weeks)
- Edinburgh Postnatal Depression Scale(12 weeks)
研究者
Barbara Posmontier
Assistant Professor
Drexel University