Clinical trial NCT04629599: IPT for Major Depression Following Perinatal Loss: Healing After Loss (HeAL)
Official title: IPT for Major Depression Following Perinatal Loss: Healing After Loss (HeAL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Perinatal loss
Depression
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Women and Infants Hospital of Rhode Island
First posted: 2020-11-16
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Time to Major Depressive Disorder recovery
timeFrame: censored at 28 weeks, the proposed study duration
Secondary outcomes:
measure: Depressive symptoms
timeFrame: 8, 16, and 28 weeks after intake
measure: PTSD symptoms
timeFrame: 8, 16, and 28 weeks after intake
measure: Time to PTSD recovery
timeFrame: censored at 28 weeks, the proposed study duration
measure: Overall perceived social support
timeFrame: 8, 16, and 28 weeks after intake
measure: Dyadic social support (from partner or another important person)
timeFrame: 8, 16, and 28 weeks after intake
measure: Social role functioning (including parental functioning)
timeFrame: 8, 16, and 28 weeks after intake
measure: Well-being
timeFrame: 8, 16, and 28 weeks after intake
measure: Grief symptoms
timeFrame: 8, 16, and 28 weeks after intake
measure: Complicated grief symptoms
timeFrame: 8, 16, and 28 weeks after intake
measure: Perceived deservingness of loss and guilt over loss
timeFrame: 8, 16, an 28 weeks after intake
measure: Fear of subsequent pregnancies
timeFrame: 8, 16, and 28 weeks after intake
Other outcomes:
measure: Treatment acceptability
timeFrame: 16 weeks after intake
Locations:
city: Flint
country: United States
facility: Anywhere in the entire state of Michigan (treatment is virtual)
state: Michigan
Study officials:
affiliation: Michigan State University
name: Jennifer E Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson JE, Price AB, Kao JC, Fernandes K, Stout R, Gobin RL, Zlotnick C. Interpersonal psychotherapy (IPT) for major depression following perinatal loss: a pilot randomized controlled trial. Arch Womens Ment Health. 2016 Oct;19(5):845-59. doi: 10.1007/s00737-016-0625-5. Epub 2016 Mar 22.
citation: Johnson JE, Price AB, Sikorskii A, Key KD, Taylor B, Lamphere S, Huff C, Cinader M, Zlotnick C. Protocol for the Healing After Loss (HeAL) Study: a randomised controlled trial of interpersonal psychotherapy (IPT) for major depression following perinatal loss. BMJ Open. 2022 Apr 19;12(4):e057747. doi: 10.1136/bmjopen-2021-057747.