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 range18 Years – 50 Years
SexFEMALE
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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
What they're measuring
1
Time to Major Depressive Disorder recovery
Timeframe: censored at 28 weeks, the proposed study duration