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Completed

NCT Number: NCT04629599

IPT for Major Depression Following Perinatal Loss: Healing After Loss (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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Flint, Michigan, 48502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: IPT

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.

Other names: CWD

Primary outcomes

  1. Time to Major Depressive Disorder recovery

    Time frame: censored at 28 weeks, the proposed study duration

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

Secondary outcomes

  1. Depressive symptoms

    Time frame: 8, 16, and 28 weeks after intake

    Overall score on the Quick Inventory of Depressive Symptoms (QIDS; lower is better)

  2. PTSD symptoms

    Time frame: 8, 16, and 28 weeks after intake

    Life Events Checklist and PTSD Checklist for DSM-5 (LEC-PCL; lower is better)

  3. Time to PTSD recovery

    Time frame: censored at 28 weeks, the proposed study duration

    Assessed via the Longitudinal Interval Follow-Up Evaluation (LIFE; lower is better)

  4. Overall perceived social support

    Time frame: 8, 16, and 28 weeks after intake

    Overall score of the Multidimensional Scale of Perceived Social Support (higher is better)

  5. Dyadic social support (from partner or another important person)

    Time frame: 8, 16, and 28 weeks after intake

    Overall score of the Relationship Assessment Scale (higher is better)

  6. Social role functioning (including parental functioning)

    Time frame: 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)

  7. Well-being

    Time frame: 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)

  8. Grief symptoms

    Time frame: 8, 16, and 28 weeks after intake

    Overall score of the Perinatal Bereavement Grief Scale (lower is better)

  9. Complicated grief symptoms

    Time frame: 8, 16, and 28 weeks after intake

    Overall score of the Inventory of Complicated Grief (lower is better)

  10. Perceived deservingness of loss and guilt over loss

    Time frame: 8, 16, an 28 weeks after intake

    Loss Beliefs Scale (lower is better)

  11. Fear of subsequent pregnancies

    Time frame: 8, 16, and 28 weeks after intake

    Overall score of the Fear of subsequent pregnancies measure (lower is better)

Other outcomes

  1. Treatment acceptability

    Time frame: 16 weeks after intake

    Client Satisfaction Questionnaire - Revised (CSQ-8-R; higher is better)

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • Women and Infants Hospital of Rhode Island

Registry information

Acronym: HeAL

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 16, 2020
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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