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

Brown University

Status: Completed

Conditions: Neonatal Death; Major Depressive Disorder; Stillbirth; Miscarriage

Treatments: Behavioral: Coping with Depression (CWD); Behavioral: Group Interpersonal Psychotherapy (IPT-G)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01867749

5R34MH086682-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Group Interpersonal Psychotherapy (IPT-G)

Experimental group

Description:

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.

Treatment:

Behavioral: Group Interpersonal Psychotherapy (IPT-G)

Coping with Depression (CWD)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Coping with Depression (CWD)