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

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

Detailed Description
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Brief interpersonal psychotherapy
* Behavioral: Facilitated referral for treatment as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Behavioral: Brief interpersonal psychotherapy<br>* 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.<br>|
| Active Comparator: B<br> | Behavioral: Facilitated referral for treatment as usual<br>* F-TAU includes providing verbal and written information regarding depressive symptoms and a referral for treatment at a behavioral health clinic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms |  | Measured throughout treatment and at Months 2 and 6 postpartum | 
| Treatment attendance |  | Measured at Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perinatal Depression, Interpersonal Psychotherapy