Evaluating the Effectiveness of Brief Interpersonal Psychotherapy for Pregnant Women With Depression

Depression Clinical Trial

Official title:

Culturally Relevant Brief Interpersonal Psychotherapy (IPT-B) for Perinatal Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292903
• Other study ID #: MH30915
• Secondary ID: 5R01MH084897-03D
• Status: Completed
• Phase: N/A
• First received: February 15, 2006
• Last updated: September 6, 2012
• Start date: March 2004
• Est. completion date: December 2007

Study information

• Verified date: September 2012
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will compare the effectiveness of brief interpersonal psychotherapy versus standard treatment for pregnant women with depression.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Brief interpersonal psychotherapy
IPT-B sessions 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.
• Facilitated referral for treatment as usual
F-TAU includes providing verbal and written information regarding depressive symptoms and a referral for treatment at a behavioral health clinic.

Locations

Country	Name	City	State
United States	Magee Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms		Measured throughout treatment and at Months 2 and 6 postpartum	No
Primary	Treatment attendance		Measured at Week 12	No