NCT04629599Completed
IPT for Major Depression Following Perinatal Loss: Healing After Loss (HeAL)
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 199 (actual)
- First submitted
- 10 Nov 2020
- Start date
- 1 Aug 2021
- Primary completion date
- 1 Nov 2025
- Lead sponsor
- Michigan State University
- Diseases
- Depression
- NCT number
- NCT04629599
What you commit to
- Study type: Interventional
- Participants enrolled: 199
- From 1 Aug 2021 to the primary completion date, 1 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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
Other illness
- current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder
- primary diagnosis of current substance use disorder
Other
- acute suicidal or homicidal risk
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anywhere in the entire state of Michigan (treatment is virtual) Coordinator of this site? Confirm its status | Flint | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.