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

NCT ID: NCT00292903

Last Updated: 2012-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2007-12-31

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.

Conditions

Depression

Keywords

Perinatal Depression; Interpersonal Psychotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

Brief interpersonal psychotherapy

Intervention Type: BEHAVIORAL

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.

B

Group Type: ACTIVE_COMPARATOR

Facilitated referral for treatment as usual

Intervention Type: BEHAVIORAL

F-TAU includes providing verbal and written information regarding depressive symptoms and a referral for treatment at a behavioral health clinic.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

University of Pittsburgh

Principal Investigators

Nancy K. Grote, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh, School of Social Work

Locations

Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Jones KA, Freijah I, Brennan SE, McKenzie JE, Bright TM, Fiolet R, Kamitsis I, Reid C, Davis E, Andrews S, Muzik M, Segal L, Herrman H, Chamberlain C. Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014874. doi: 10.1002/14651858.CD014874.pub2.

Reference Type: DERIVED

PMID: 37146219 (View on PubMed)

Other Identifiers

5R01MH084897-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR 83-ATSO

Identifier Type: -

Identifier Source: secondary_id

MH30915

Identifier Type: -

Identifier Source: org_study_id