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Multidisciplinary Model of Nurse Midwife

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CNM Interpersonal Psychotherapy
Treatment as Usual
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression focused on measuring Postpartum Depression, Nurse Midwife, Interpersonal Psychotherapy

Eligibility Criteria

16 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Drexel University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CNM Interpersonal Psychotherapy

Treatment as Usual

Arm Description

CNM Interpersonal psychotherapy

Treatment as Usual is psychotherapy with a mental health provider

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for depression
Measure of depression severity

Secondary Outcome Measures

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

Full Information

First Posted
May 24, 2010
Last Updated
August 5, 2015
Sponsor
Drexel University
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1. Study Identification

Unique Protocol Identification Number
NCT01935375
Brief Title
Multidisciplinary Model of Nurse Midwife
Official Title
Multidisciplinary Model of Nurse Midwife Psychotherapy for Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Drexel University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
HYPOTHESES: The hypotheses are that: nurse midwives will be able to safely deliver interpersonal psychotherapy by telephone to women with postpartum depression women receiving interpersonal psychotherapy will have less symptoms of postpartum depression, better functioning, better bonding with their babies, and better relationships with their partners 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: 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. The preliminary evidence of efficacy of IPT in decreasing depressive symptoms when administered via telephone by nurse-midwives/ women's health nurse practitioner The proposed study will also evaluate preliminary evidence for the efficacy of IPT administered by nurse midwives in Improving the general level of maternal functioning Specific improvement in marital adjustment 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Postpartum Depression, Nurse Midwife, Interpersonal Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CNM Interpersonal Psychotherapy
Arm Type
Experimental
Arm Description
CNM Interpersonal psychotherapy
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Treatment as Usual is psychotherapy with a mental health provider
Intervention Type
Behavioral
Intervention Name(s)
CNM Interpersonal Psychotherapy
Intervention Description
Eight Weekly 50 minute sessions CNM Interpersonal Psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Treatment as Usual is psychotherapy provided by a mental health provider
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for depression
Description
Measure of depression severity
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Global Assessment of functioning
Description
Measure of functional status
Time Frame
12 weeks
Title
Dyadic Adjustment Scale
Description
Measure of dyadic adjustment of marital couple
Time Frame
12 weeks
Title
Social Support Questionnaire
Description
Measure of improvement in social support
Time Frame
12 weeks
Title
Client Satisfaction Questionnaire
Description
Measure of client satisfaction with midwife counseling
Time Frame
12 weeks
Title
Edinburgh Postnatal Depression Scale
Description
Measure of severity of postpartum depression
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara E Posmontier, PHD
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Neugebauer, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Stuart, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rita Shaughnessy, PhD, MD
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel University
City
Phila
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States

12. IPD Sharing Statement

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Multidisciplinary Model of Nurse Midwife

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