Multidisciplinary Model of Nurse Midwife

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Multidisciplinary Model of Nurse Midwife Psychotherapy for Postpartum Depression

Conditions
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Postpartum Depression

Intervention / Treatment
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* Behavioral: CNM Interpersonal Psychotherapy
* Behavioral: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CNM Interpersonal Psychotherapy<br>CNM Interpersonal psychotherapy | Behavioral: CNM Interpersonal Psychotherapy<br>* Eight Weekly 50 minute sessions CNM Interpersonal Psychotherapy<br>|
| Active Comparator: Treatment as Usual<br>Treatment as Usual is psychotherapy with a mental health provider | Behavioral: Treatment as Usual<br>* Treatment as Usual is psychotherapy provided by a mental health provider<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for depression | Measure of depression severity | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment of functioning | Measure of functional status | 12 weeks | 
| Dyadic Adjustment Scale | Measure of dyadic adjustment of marital couple | 12 weeks | 
| Social Support Questionnaire | Measure of improvement in social support | 12 weeks | 
| Client Satisfaction Questionnaire | Measure of client satisfaction with midwife counseling | 12 weeks | 
| Edinburgh Postnatal Depression Scale | Measure of severity of postpartum depression | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum Depression, Nurse Midwife, Interpersonal Psychotherapy