Multidisciplinary Model of Nurse Midwife

Postpartum Depression Clinical Trial

Official title:

Multidisciplinary Model of Nurse Midwife Psychotherapy for Postpartum Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935375
• Other study ID #: 18981
• Status: Completed
• Phase: N/A
• First received: May 24, 2010
• Last updated: August 5, 2015
• Start date: July 2010
• Est. completion date: June 2014

Study information

• Verified date: August 2015
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Behavioral:
• CNM Interpersonal Psychotherapy
Eight Weekly 50 minute sessions CNM Interpersonal Psychotherapy
• Treatment as Usual
Treatment as Usual is psychotherapy provided by a mental health provider

Locations

Country	Name	City	State
United States	Drexel University	Phila	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for depression	Measure of depression severity	12 weeks	No
Secondary	Global Assessment of functioning	Measure of functional status	12 weeks	No
Secondary	Dyadic Adjustment Scale	Measure of dyadic adjustment of marital couple	12 weeks	No
Secondary	Social Support Questionnaire	Measure of improvement in social support	12 weeks	No
Secondary	Client Satisfaction Questionnaire	Measure of client satisfaction with midwife counseling	12 weeks	No
Secondary	Edinburgh Postnatal Depression Scale	Measure of severity of postpartum depression	12 weeks	No