Clinical trial NCT00282776: Identification and Therapy of Postpartum Depression
Official title: Identification and Therapy of Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Keywords: Postpartum Depression
Telephone Care Management
Screening for Postpartum Depression
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-01-27
Enrollment: 628
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women.

Detailed description: Depression is a serious illness that can interfere with everyday life. Researchers believe that it is one of the most common complications during and after pregnancy. Depression after pregnancy is called postpartum depression and may be caused by a rapid change in hormone levels during and immediately after pregnancy. Postpartum depression can occur anytime within the first year after childbirth and can negatively affect both mothers and their children. Mothers with postpartum depression may experience low energy, difficulty concentrating, irritability, and inability to meet their children's needs for love and affection. As a result, women with postpartum depression may feel guilty and lose confidence in themselves as parents. Research shows that children of mothers with postpartum depression may have delays in language development, difficulty with emotional bonding to others, behavioral problems, lower activity levels, sleep problems, and distress. This study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women.

Participants in this single blind study will be randomly assigned to receive either enhanced treatment as usual or telephone-based care management for the first year postpartum. All participants will have a 90-minute in-home interview upon study entry to assess depressive symptoms, functional status, medical history, and post-pregnancy plans. Participants assigned to care management will receive two calls in the first month postpartum, followed by monthly calls for the remainder of the first postpartum year. During each 10- to 20-minute call, participants will be asked to provide information regarding current depressive symptoms, steps they have taken to seek depression-related care, and any barriers they have encountered in the process. In addition, a care manager will act as an advocate for the participants and assist in obtaining specialized services as necessary throughout the year. Participants assigned to receive enhanced treatment as usual will not receive monthly phone calls or tailored care management. All participants will receive follow-up calls at 3, 6, and 12 months postpartum to assess outcome measures; these calls will last about 30 minutes.

Eligibility criteria: Inclusion Criteria:

* 4-6 weeks postpartum
* English-speaking
* Score of at least 10 on the Edinburgh Postnatal Depression Scale

Exclusion Criteria:

* DSM-IV diagnosis of bipolar disorder or psychotic episode
* Active substance abuse within 6 months prior to study entry
* Has not received obstetrical care
* History of a suicide attempt within 6 months of study entry

Primary outcomes:
measure: Depressive symptoms, social functioning, and health
timeFrame: Measured at Months 3, 6, and 12 postpartum
measure: Preferences for depression treatment
timeFrame: Measured at baseline and Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Women's Behavioral HealthCARE Program, Suite 410, 3501 Forbes Ave
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Katherine L. Wisner, MD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wisner KL, Sit DKY, McShea M, Luther JF, Eng HF, Dills JL, Moses-Kolko EL, Wisniewski SR. Telephone-Based Depression Care Management for Postpartum Women: A Randomized Controlled Trial. J Clin Psychiatry. 2017 Nov-Dec;78(9):1369-1375. doi: 10.4088/JCP.15m10563.
citation: Clark CT, Sit DK, Driscoll K, Eng HF, Confer AL, Luther JF, Wisniewski SR, Wisner KL. DOES SCREENING WITH THE MDQ AND EPDS IMPROVE IDENTIFICATION OF BIPOLAR DISORDER IN AN OBSTETRICAL SAMPLE? Depress Anxiety. 2015 Jul;32(7):518-26. doi: 10.1002/da.22373. Epub 2015 Jun 8.
citation: Wisner KL, Sit DK, McShea MC, Rizzo DM, Zoretich RA, Hughes CL, Eng HF, Luther JF, Wisniewski SR, Costantino ML, Confer AL, Moses-Kolko EL, Famy CS, Hanusa BH. Onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. JAMA Psychiatry. 2013 May;70(5):490-8. doi: 10.1001/jamapsychiatry.2013.87.
citation: Sit D, Seltman H, Wisner KL. Seasonal effects on depression risk and suicidal symptoms in postpartum women. Depress Anxiety. 2011 May;28(5):400-5. doi: 10.1002/da.20807. Epub 2011 Mar 4.