Multidisciplinary Model of Nurse Midwife

Multidisciplinary Model of Nurse Midwife Psychotherapy for Postpartum Depression

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Depression
• Intervention / Treatment: Behavioral: CNM Interpersonal Psychotherapy; Behavioral: Treatment as Usual

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Phila, Pennsylvania, United States, 19102
      • Drexel University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Drexel University
• Investigators: Principal Investigator: Barbara E Posmontier, PHD, Drexel University; Principal Investigator: Richard Neugebauer, PhD, Columbia University; Principal Investigator: Rita Shaughnessy, PhD, MD, Drexel University

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: May 24, 2010
• First Submitted That Met QC Criteria: August 30, 2013
• First Posted (Estimate): September 5, 2013

Study Record Updates

• Last Update Posted (Estimate): August 7, 2015
• Last Update Submitted That Met QC Criteria: August 5, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Postpartum Depression; Interpersonal Psychotherapy; Nurse Midwife
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 18981