NCT01935375

Brief Summary

HYPOTHESES: The hypotheses are that:

  1. 1.nurse midwives will be able to safely deliver interpersonal psychotherapy by telephone to women with postpartum depression
  2. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

August 7, 2015

Status Verified

August 1, 2015

Enrollment Period

3.9 years

First QC Date

May 24, 2010

Last Update Submit

August 5, 2015

Conditions

Postpartum Depression

Keywords

Postpartum DepressionNurse MidwifeInterpersonal Psychotherapy

Outcome Measures

Primary Outcomes (1)

  • Hamilton Rating Scale for depression

    Measure of depression severity

    12 weeks

Secondary Outcomes (5)

  • Global Assessment of functioning

    12 weeks

  • Dyadic Adjustment Scale

    12 weeks

  • Social Support Questionnaire

    12 weeks

  • Client Satisfaction Questionnaire

    12 weeks

  • Edinburgh Postnatal Depression Scale

    12 weeks

Study Arms (2)

CNM Interpersonal Psychotherapy

EXPERIMENTAL

CNM Interpersonal psychotherapy

Behavioral: CNM Interpersonal Psychotherapy

Treatment as Usual

ACTIVE COMPARATOR

Treatment as Usual is psychotherapy with a mental health provider

Behavioral: Treatment as Usual

Interventions

CNM Interpersonal PsychotherapyBEHAVIORAL

Eight Weekly 50 minute sessions CNM Interpersonal Psychotherapy

CNM Interpersonal Psychotherapy
Treatment as UsualBEHAVIORAL

Treatment as Usual is psychotherapy provided by a mental health provider

Treatment as Usual

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 24 weeks postpartum
  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Barbara E Posmontier, PHD

    Drexel University

    PRINCIPAL INVESTIGATOR

  • Richard Neugebauer, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Scott Stuart, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

  • Rita Shaughnessy, PhD, MD

    Drexel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 24, 2010

First Posted

September 5, 2013

Study Start

July 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 7, 2015

Record last verified: 2015-08

Locations

US(1)