Interpersonal psychotherapy for depression after perinatal loss
IPT for Major Depression Following Perinatal Loss: Healing After Loss (HeAL)
This study is testing if a type of therapy called interpersonal psychotherapy can help women who are feeling very depressed after losing a baby, to see if it works better than a standard depression treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Michigan State University Academic / other |
| Locations | 1 site (Flint, Michigan) |
| Trial ID | NCT04629599 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of interpersonal psychotherapy (IPT) for women suffering from major depression following perinatal loss, including both early and late fetal deaths. A total of 274 women will participate in a randomized controlled trial comparing IPT to a standard depression intervention known as Coping with Depression (CWD). The study aims to determine if IPT can lead to quicker recovery from depression and PTSD symptoms, enhance social support and well-being, and reduce grief and anxiety about future pregnancies. This is the first fully powered trial to address psychiatric disorders in the context of perinatal loss.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 50 who have experienced a perinatal loss within the last 1-12 months and meet the criteria for major depressive disorder.
Not a fit: Patients with a history of bipolar disorder, schizophrenia, or other psychotic disorders, as well as those with acute suicidal risk, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective therapeutic option for women experiencing major depression after perinatal loss.
How similar studies have performed: This approach is novel, as it is the first fully powered randomized trial specifically targeting psychiatric disorders following perinatal loss.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Flint, Michigan
- Anywhere in the entire state of Michigan (treatment is virtual) — Flint, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer E Johnson, PhD — Michigan State University
- Study coordinator: Jennifer E Johnson, PhD
- Email: jjohns@msu.edu
- Phone: 810-600-5669
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.