Clinical trial NCT01935375: Multidisciplinary Model of Nurse Midwife
Official title: Multidisciplinary Model of Nurse Midwife Psychotherapy for Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Keywords: Postpartum Depression
Nurse Midwife
Interpersonal Psychotherapy
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 61
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Primary outcomes:
measure: Hamilton Rating Scale for depression
timeFrame: 12 weeks
Secondary outcomes:
measure: Global Assessment of functioning
timeFrame: 12 weeks
measure: Dyadic Adjustment Scale
timeFrame: 12 weeks
measure: Social Support Questionnaire
timeFrame: 12 weeks
measure: Client Satisfaction Questionnaire
timeFrame: 12 weeks
measure: Edinburgh Postnatal Depression Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Phila
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Barbara E Posmontier, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Richard Neugebauer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Scott Stuart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Drexel University
name: Rita Shaughnessy, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: