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

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.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Interpersonal psychotherapy for major depression following perinatal loss; Behavioral: Coping with Depression

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 Type: Interventional
• Enrollment (Estimated): 274
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Jennifer E Johnson, PhD; Phone Number: 810-600-5669; Email: jjohns@msu.edu

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 48502
      • Recruiting
      • Anywhere in the entire state of Michigan (treatment is virtual)
      • Contact: Susan Lamphere, MSW; Phone Number: 810-516-0319; Email: heal@msu.edu
      • Contact: Susan Lamphere, MSU; Phone Number: 810-600-5672; Email: Lamphe14@msu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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.; Other Names: IPT
Active Comparator: 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.	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.; Other Names: CWD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment acceptability	Client Satisfaction Questionnaire - Revised (CSQ-8-R; higher is better)	16 weeks after intake

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: Women and Infants Hospital of Rhode Island
• Investigators: Principal Investigator: Jennifer E Johnson, PhD, Michigan State University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Depression; Perinatal loss
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: R01HD100471 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This project will meet NICHD's timelines and requirements for depositing relevant de-identified data into relevant national databases. This will be reflected in study consent forms. De-identified data will be also made available to qualified researchers upon request, on a compact disk (CD) or other electronic means compatible with our systems. The request will be evaluated by the Principal Investigator to ensure that it meets reasonable standards of scientific integrity.
• IPD Sharing Time Frame: Data sharing will occur on NIH-designated timelines.
• IPD Sharing Access Criteria: Request needs to meet reasonable standards of scientific integrity, as judged by the Study Principal Investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No