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
About this trial
This is an interventional treatment trial for Postpartum Depression focused on measuring Postpartum Depression, Nurse Midwife, Interpersonal Psychotherapy
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).
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
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
Learn more about this trial
Multidisciplinary Model of Nurse Midwife
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