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

NCT04629599 | Completed DMC

• 1 other identifier: R01HD100471
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Perinatal loss; Depression

Outcome Measures

Primary Outcomes (1)

• Time to Major Depressive Disorder recovery

  Assessed via the Longitudinal Interview Follow-up Evaluation (LIFE; lower is better)

  censored at 28 weeks, the proposed study duration

Secondary Outcomes (11)

• Depressive symptoms

  8, 16, and 28 weeks after intake

• PTSD symptoms

  8, 16, and 28 weeks after intake

• Time to PTSD recovery

  censored at 28 weeks, the proposed study duration

• Overall perceived social support

  8, 16, and 28 weeks after intake

• Dyadic social support (from partner or another important person)

  8, 16, and 28 weeks after intake

Other Outcomes (1)

• Treatment acceptability

  16 weeks after intake

Study Arms (2)

Interpersonal psychotherapy for major depression following perinatal loss

EXPERIMENTAL

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: Interpersonal psychotherapy for major depression following perinatal loss

Coping with Depression

ACTIVE COMPARATOR

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.

Behavioral: Coping with Depression

Interventions

Coping with Depression BEHAVIORAL

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.

Also known as: CWD

Coping with Depression

Interpersonal psychotherapy for major depression following perinatal loss BEHAVIORAL

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.

Also known as: IPT

Interpersonal psychotherapy for major depression following perinatal loss

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Adult women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michigan State University: lead
• Women and Infants Hospital of Rhode Island: collaborator

Study Sites (1)

Anywhere in the entire state of Michigan (treatment is virtual)

Flint, Michigan, 48502, United States

Location

Related Publications (2)

• Johnson JE, Price AB, Kao JC, Fernandes K, Stout R, Gobin RL, Zlotnick C. Interpersonal psychotherapy (IPT) for major depression following perinatal loss: a pilot randomized controlled trial. Arch Womens Ment Health. 2016 Oct;19(5):845-59. doi: 10.1007/s00737-016-0625-5. Epub 2016 Mar 22.

  PMID: 27003141 BACKGROUND

• Johnson JE, Price AB, Sikorskii A, Key KD, Taylor B, Lamphere S, Huff C, Cinader M, Zlotnick C. Protocol for the Healing After Loss (HeAL) Study: a randomised controlled trial of interpersonal psychotherapy (IPT) for major depression following perinatal loss. BMJ Open. 2022 Apr 19;12(4):e057747. doi: 10.1136/bmjopen-2021-057747.

  PMID: 35440458 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Interpersonal Psychotherapy; Coping Skills

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy

Study Officials

• Jennifer E Johnson, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: C. S. Mott Endowed Professor of Public Health

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 16, 2020
• Study Start: August 1, 2021
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data sharing will occur on NIH-designated timelines.
• Access Criteria: Request needs to meet reasonable standards of scientific integrity, as judged by the Study Principal Investigator

Locations

US (1)