Multidisciplinary Model of Nurse Midwife

NCT ID: NCT01935375

Last Updated: 2015-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-06-30

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

Conditions

Postpartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CNM Interpersonal Psychotherapy

CNM Interpersonal psychotherapy

Group Type: EXPERIMENTAL

CNM Interpersonal Psychotherapy

Intervention Type: BEHAVIORAL

Eight Weekly 50 minute sessions CNM Interpersonal Psychotherapy

Treatment as Usual

Treatment as Usual is psychotherapy with a mental health provider

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

Treatment as Usual is psychotherapy provided by a mental health provider

Interventions

CNM Interpersonal Psychotherapy

Eight Weekly 50 minute sessions CNM Interpersonal Psychotherapy

Intervention Type: BEHAVIORAL

Treatment as Usual

Treatment as Usual is psychotherapy provided by a mental health provider

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Drexel University

OTHER

Sponsor Role: lead

Responsible Party

Barbara Posmontier

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara E Posmontier, PHD

Role: PRINCIPAL_INVESTIGATOR

Drexel University

Richard Neugebauer, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Scott Stuart, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Rita Shaughnessy, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Drexel University

Locations

Drexel University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

18981

Identifier Type: -

Identifier Source: org_study_id