IPT for Major Depression Following Perinatal Loss: Healing After Loss (HeAL)

Summary

This study tests the efficacy of interpersonal psychotherapy (IPT) for major depression following perinatal loss (early and late fetal death and early neonatal death) in a sample of 274 women in Flint and Detroit, Michigan. The trial will be the first fully powered randomized trial of treatment for any psychiatric disorder following perinatal loss.

Conditions

• Major Depressive Disorder

Interventions

BEHAVIORAL

Interpersonal psychotherapy for major depression following perinatal loss

Participants in the IPT condition will receive 12 group sessions and 2 individual (pre-group and 1-month booster) sessions as outlined in the manual The individual sessions prepare patients to use the group effectively, to keep group members focused on their treatment goals, and to maintain treatment gains. 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. These sessions are important because relationship distress is common following perinatal loss. Our IPT intervention allows new women to enter the group every 4 weeks of the 12-week group. Group sessions are semi-structured, and each woman will cover the four group topics three times, approaching each topic from a different stage in the mourning process.

BEHAVIORAL

Coping with Depression

The Coping with Depression (CWD) course is a structured, manualized psycho-educational group treatment for MDD. The CWD course is based on social learning theory which posits that depression is associated with a decrease in pleasant and an increase in unpleasant person-environment interactions. The problems shown by depressed individuals are viewed as behavioral, with cognitive patterns that can be unlearned or relearned. Its effectiveness is comparable to other forms of psychotherapy in depression. 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. As in the pilot trial, CWD will consist of an individual pregroup session, 12 group therapy sessions (allowing new women to enter every 4th session) and a 1-month individual booster session to provide an identical treatment dose as the experimental condition.

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island

  collaborator OTHER

• Michigan State University

  lead OTHER

Principal Investigators

• Jennifer E Johnson, PhD · Michigan State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-01

Primary Completion

2025-11-01

Completion

2025-11-01

Countries

• United States

Study Locations