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

Not Applicable

Recruiting

• Conditions: Major Depressive Disorder

• Registration Number: NCT04629599
• Lead Sponsor: Michigan State University

Brief 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.

Detailed Description

The goal of this study is to conduct a fully-powered randomized efficacy study of IPT for MDD following perinatal loss. Our perinatal-loss adapted group IPT will be compared to a standard depression intervention (CWD, also delivered in a group format) in a sample of 274 women experiencing MDD following perinatal loss. The proposed randomized controlled trial (RCT) will test the hypotheses that: (1) IPT for perinatal loss will result in reduced time to recovery from MDD (primary), depressive symptoms, and PTSD symptoms (secondary) relative to CWD; and that among women meeting criteria for PTSD, IPT will result in reduced time to recovery from PTSD; (2) IPT for perinatal loss will result in increased social support, social role functioning (including parental functioning for women with living children), and well-being, and decreased grief and fear of subsequent pregnancies, relative to CWD; and (3) social support and grief will mediate the effects of IPT on time to MDD recovery.

Study Timeline

• Study First Submitted: 2020-11-10
• Study First Submitted QC: 2020-11-10
• Study First Posted: 2020-11-16
• Study Start: 2021-08-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• women who meet current Diagnostic and Statistical Manual 5 (DSM-5) criteria for major depressive disorder (MDD)
• have experienced a perinatal loss (including early and late fetal death, death of a liveborn neonate within the first 28 days, and medically recommended termination) within the last 1-12 months
• are 18 to 50 years old
• speak and understand English well enough to understand questionnaires when they are read aloud
• can provide the name and contact information of at least two locator persons
• have access to a telephone through owning one, a relative/friend, or an agency

Exclusion Criteria

• 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 disorder, schizophrenia or other psychotic disorder
• primary diagnosis of current substance use 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 12 weeks)
• any IPT or cognitive-behavioral treatment in the previous 12 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to Major Depressive Disorder recovery	censored at 28 weeks, the proposed study duration	Assessed via the Longitudinal Interview Follow-up Evaluation (LIFE; lower is better)

Secondary Outcome Measures

Name	Time	Method
Grief symptoms	8, 16, and 28 weeks after intake	Overall score of the Perinatal Bereavement Grief Scale (lower is better)
PTSD symptoms	8, 16, and 28 weeks after intake	Life Events Checklist and PTSD Checklist for DSM-5 (LEC-PCL; lower is better)
Time to PTSD recovery	censored at 28 weeks, the proposed study duration	Assessed via the Longitudinal Interval Follow-Up Evaluation (LIFE; lower is better)
Well-being	8, 16, and 28 weeks after intake	Overall score of the NIH Neuro-Quality of Life scale for positive affect and well-being (higher is better)
Complicated grief symptoms	8, 16, and 28 weeks after intake	Overall score of the Inventory of Complicated Grief (lower is better)
Depressive symptoms	8, 16, and 28 weeks after intake	Overall score on the Quick Inventory of Depressive Symptoms (QIDS; lower is better)
Overall perceived social support	8, 16, and 28 weeks after intake	Overall score of the Multidimensional Scale of Perceived Social Support (higher is better)
Dyadic social support (from partner or another important person)	8, 16, and 28 weeks after intake	Overall score of the Relationship Assessment Scale (higher is better)
Social role functioning (including parental functioning)	8, 16, and 28 weeks after intake	Overall score of the Short version of the Social Adjustment Scale (SAS) - Self Report and parental functioning SAS subscale (lower is better)
Perceived deservingness of loss and guilt over loss	8, 16, an 28 weeks after intake	Loss Beliefs Scale (lower is better)
Fear of subsequent pregnancies	8, 16, and 28 weeks after intake	Overall score of the Fear of subsequent pregnancies measure (lower is better)

Trial Locations

Locations (1)

Anywhere in the entire state of Michigan (treatment is virtual); 🇺🇸 Flint, Michigan, United States