Clinical trial NCT00292903: Evaluating the Effectiveness of Brief Interpersonal Psychotherapy for Pregnant Women With Depression
Official title: Culturally Relevant Brief Interpersonal Psychotherapy (IPT-B) for Perinatal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Perinatal Depression
Interpersonal Psychotherapy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-02-16
Enrollment: 60
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 compare the effectiveness of brief interpersonal psychotherapy versus standard treatment for pregnant women with depression.

Detailed description: Depression is a serious condition affecting millions of people each year. In fact, it is estimated that approximately one in every four women will be treated for a mood disorder, such as depression, at some point in her life. As effective treatment options continue to develop, many women diagnosed with depression are able to resume normal lives and may choose to become pregnant. Also, some women become depressed when pregnant. Interpersonal psychotherapy involves treating psychological difficulties by analyzing problems, talking about possible solutions, and learning more helpful ways of thinking and acting. Brief interpersonal psychotherapy (IPT-B) is a well-tested psychotherapy for depression that has been shortened and modified. The purpose of this study is to evaluate the effectiveness of IPT-B to reduce depressive symptoms in women during pregnancy and to prevent the continuation or recurrence of their depression postpartum.

Participants in this open-label study will be randomly assigned to receive either IPT-B or a facilitated referral for treatment as usual (F-TAU) at an outpatient clinic or community mental health center. Participants assigned to IPT-B will be scheduled to attend eight treatment sessions along with their prenatal clinic visits within a 16-week period. Each treatment session will begin with a brief 1-minute evaluation to assess participants' level of depression and will end with a brief evaluation of the session. Participants will attend follow-up sessions every 2 weeks until 3 months postpartum and then monthly until 6 months postpartum. These sessions will include evaluation of participants' level of depression, identification of any difficulties or problems that participants may be experiencing, and review of how to manage these problems using skills learned during treatment. Participants assigned to receive F-TAU will be provided with verbal and written information regarding their depressive symptoms. They will also receive a referral for treatment at a behavioral health clinic. Participants receiving F-TAU will be assessed via telephone at Weeks 6 and 12. All participants will be assessed via telephone at Months 2 and 6 postpartum to measure their level of depression.

Eligibility criteria: Inclusion Criteria:

* Between 8 and 32 weeks of gestation at time of study entry
* A score above 12 on the Edinburgh Postnatal Depression Scale
* Speaks English
* Resides in the Pittsburgh, PA, area
* Access to a household telephone

Exclusion Criteria:

* Currently receiving treatment for depression (i.e., medication or psychotherapy)
* History of a prior manic episode
* Alcohol or drug abuse or dependence within 6 months of study entry
* Psychotic disorder or organic mental disorder
* Suicidal, homicidal, or requires hospitalization
* Severe sexual and/or physical aggression in relationship with partner or husband
* Significant medical illness such as epilepsy, autoimmune disorder, liver dysfunction, or unstable endocrine disease
* Severe cognitive deficits that would prevent treatment with psychotherapy

Primary outcomes:
measure: Depressive symptoms
timeFrame: Measured throughout treatment and at Months 2 and 6 postpartum
measure: Treatment attendance
timeFrame: Measured at Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh, School of Social Work
name: Nancy K. Grote, PhD
role: PRINCIPAL_INVESTIGATOR
References: