Multidisciplinary Model of Nurse Midwife

N/ACompletedNCT01935375

Drexel University61 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Postpartum Depression

Interventions

CNM Interpersonal PsychotherapyBEHAVIORAL

Eight Weekly 50 minute sessions CNM Interpersonal Psychotherapy

Treatment as UsualBEHAVIORAL

Treatment as Usual is psychotherapy provided by a mental health provider

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 45 Years

Medical Language ↔ Plain English

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).

Locations (1)

Drexel University

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Hamilton Rating Scale for depression

Measure of depression severity

Time frame: 12 weeks

Secondary Outcomes

Global Assessment of functioning

Measure of functional status

Time frame: 12 weeks

Dyadic Adjustment Scale

Measure of dyadic adjustment of marital couple

Time frame: 12 weeks

Social Support Questionnaire

Measure of improvement in social support

Time frame: 12 weeks

Client Satisfaction Questionnaire

Measure of client satisfaction with midwife counseling

Time frame: 12 weeks

Edinburgh Postnatal Depression Scale

Measure of severity of postpartum depression

Time frame: 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.