Group Interpersonal Psychotherapy for Treatment of Major Depressive Disorder Following Perinatal Loss

NCT ID: NCT01867749

Last Updated: 2016-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2014-06-30

Brief Summary

The purpose of this study is to conduct a randomized pilot trial in a sample of 60 women who meet criteria for Major Depressive Disorder (MDD) 1-18 months after a perinatal loss to demonstrate the feasibility of the proposed recruitment methods and research design, of the therapist training methods, and of delivering the adapted Interpersonal Psychotherapy group treatment.

The investigators would like to examine preliminary evidence for the following hypotheses:

• Perinatal-loss specific IPT-G will be more acceptable to women who experience MDD following perinatal loss than will Coping with Depression (CWD).
• Perinatal-loss specific IPT-G will result in reduced time to remission from MDD and reduced depressive symptoms relative to CWD.
• Perinatal-loss specific IPT-G will result in increased social support and social functioning, reduced couple distress, and reduced grief relative to CWD.

Conditions

Major Depressive Disorder; Miscarriage; Stillbirth; Neonatal Death

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group Interpersonal Psychotherapy (IPT-G)

Participants in the IPT-G condition will receive 12 group therapy sessions over 2 weeks as well as 2 individual (pre-group and 1-month booster sessions). In addition, 3 of the 12 group sessions will invite women to include their partners or other support people to bolster the woman's social support system and to reduce conflicts over how to react to the loss. This study adapted IPT for treatment of depression after perinatal loss.

Group Type: EXPERIMENTAL

Group Interpersonal Psychotherapy (IPT-G)

Intervention Type: BEHAVIORAL

Coping with Depression (CWD)

The Coping with Depression (CWD) course is a highly structured, manualized psycho-educational group treatment for MDD. The course content is cognitive-behavioral in nature and is designed to train skills that can be used in the alleviation of depression. The skill modules focus on relaxation, cognitive skills, and behavioral activation. CWD will consist of an individual pre-group interview, 12 group therapy sessions over 12 weeks and a 1-month individual booster session to provide an identical treatment dose as the experimental condition.

Group Type: ACTIVE_COMPARATOR

Coping with Depression (CWD)

Intervention Type: BEHAVIORAL

Interventions

Group Interpersonal Psychotherapy (IPT-G)

Intervention Type: BEHAVIORAL

Coping with Depression (CWD)

Intervention Type: BEHAVIORAL

Other Intervention Names

IPT-G; CWD

Eligibility Criteria

Inclusion Criteria

• Current Major Depressive episode.
• Experience perinatal loss 1-18 months prior to intake (including early and late fetal death and the death of a live born neonate within the first 28 days).

Exclusion Criteria

• Untreated thyroid difficulties (TSH levels out of the normal range).
• Anemia (hemoglobin or hematocrit out of the normal range).
• Onset of current major depressive episode prior to news of difficulties with the pregnancy or health risk to the infant (women with prior episodes will be included).
• Current or past diagnosis of bipolar I disorder, schizophrenia or other psychotic disorder.
• Primary diagnosis of substance dependence or eating disorder.
• Acute suicidal or homicidal risk.
• Non-stable course of antidepressant medication or psychotherapy (i.e., beginning or changing dose of either within the previous 8 weeks).
• Any IPT or cognitive-behavioral treatment in the previous 8 weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Jennifer Johnson

Associate Professor (Research)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer E. Johnson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Brown University

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

5R34MH086682-03

Identifier Type: NIH

Identifier Source: secondary_id

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5R34MH086682-03

Identifier Type: NIH

Identifier Source: org_study_id

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