IPT for Major Depression Following Perinatal Loss: Healing After Loss (HeAL) (NCT04629599) | Clinical Trial Compass
CompletedNot Applicable
IPT for Major Depression Following Perinatal Loss: Healing After Loss (HeAL)
United States199 participantsStarted 2021-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to Major Depressive Disorder recovery
Timeframe: censored at 28 weeks, the proposed study duration