Multidisciplinary Model of Nurse Midwife

Not Applicable

Completed

• Conditions: Postpartum Depression
• Interventions: Behavioral: CNM Interpersonal Psychotherapy; Behavioral: Treatment as Usual

• Registration Number: NCT01935375
• Lead Sponsor: Drexel University

Brief Summary

HYPOTHESES:

The hypotheses are that:

1. nurse midwives will be able to safely deliver interpersonal psychotherapy by telephone to women with postpartum depression

2. women receiving interpersonal psychotherapy will have less symptoms of postpartum depression, better functioning, better bonding with their babies, and better relationships with their partners

3. 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

The specific aims of this pilot non-randomized clinical trial are to evaluate among women with PPD recruited between 6 and 24 weeks postpartum:

1. 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.

2. The preliminary evidence of efficacy of IPT in decreasing depressive symptoms when administered via telephone by nurse-midwives/ women's health nurse practitioner

3. The proposed study will also evaluate preliminary evidence for the efficacy of IPT administered by nurse midwives in

1. Improving the general level of maternal functioning

2. Specific improvement in marital adjustment

3. 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

Study Timeline

• Study First Submitted: 2010-05-24
• Study Start: 2010-07
• Study First Submitted QC: 2013-08-30
• Study First Posted: 2013-09-05
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

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

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CNM Interpersonal Psychotherapy	CNM Interpersonal Psychotherapy	CNM Interpersonal psychotherapy
Treatment as Usual	Treatment as Usual	Treatment as Usual is psychotherapy with a mental health provider

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for depression	12 weeks	Measure of depression severity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Drexel University; 🇺🇸 Phila, Pennsylvania, United States