RECRUITING

IPT for Major Depression Following Perinatal Loss: Healing After Loss (HeAL)

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Conditions

Major Depressive DisorderPerinatal lossDepression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

IPT for Major Depression Following Perinatal Loss: Healing After Loss (HeAL)

Quick Facts

Study Start:2021-08-01
Study Completion:2025-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04629599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * women who meet current Diagnostic and Statistical Manual 5 (DSM-5) criteria for major depressive disorder (MDD)
  2. * 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
  3. * are 18 to 50 years old
  4. * speak and understand English well enough to understand questionnaires when they are read aloud
  5. * can provide the name and contact information of at least two locator persons
  6. * have access to a telephone through owning one, a relative/friend, or an agency
  1. * 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)
  2. * current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder
  3. * primary diagnosis of current substance use disorder
  4. * acute suicidal or homicidal risk
  5. * non-stable course of antidepressant medication or psychotherapy (i.e., beginning or changing dose of either within the previous 12 weeks)
  6. * any IPT or cognitive-behavioral treatment in the previous 12 weeks

Contacts and Locations

Study Contact

Jennifer E Johnson, PhD
CONTACT
810-600-5669
jjohns@msu.edu

Principal Investigator

Jennifer E Johnson, PhD
PRINCIPAL_INVESTIGATOR
Michigan State University

Study Locations (Sites)

Anywhere in the entire state of Michigan (treatment is virtual)
Flint, Michigan, 48502
United States

Collaborators and Investigators

Sponsor: Michigan State University

  • Jennifer E Johnson, PhD, PRINCIPAL_INVESTIGATOR, Michigan State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-01
Study Completion Date2025-11-01

Study Record Updates

Study Start Date2021-08-01
Study Completion Date2025-11-01

Terms related to this study

Keywords Provided by Researchers

  • Perinatal loss
  • Depression

Additional Relevant MeSH Terms

  • Major Depressive Disorder