← Back to Search

Interpersonal Psychotherapy for Depression After Perinatal Loss (HeAL Trial)

Phase 2 & 3
Recruiting
Led By Jennifer E Johnson, PhD
Research Sponsored by Michigan State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
are 18 to 50 years old
women who meet current Diagnostic and Statistical Manual 5 (DSM-5) criteria for major depressive disorder (MDD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks after intake
Awards & highlights

HeAL Trial Summary

This trial will test if interpersonal psychotherapy (IPT) is effective for major depression following perinatal loss.

Who is the study for?
This trial is for women aged 18-50 in Flint and Detroit, Michigan who have experienced perinatal loss within the last year and are now facing major depression. Participants must speak English, be able to provide contacts for follow-up, have telephone access, and meet specific mental health criteria without recent psychotherapy or unstable medication use.Check my eligibility
What is being tested?
The study is examining the effectiveness of interpersonal psychotherapy (IPT) specifically tailored for major depression after perinatal loss compared to standard coping strategies. It's a randomized trial aiming to be the first fully powered study in this area.See study design
What are the potential side effects?
Since IPT involves therapy sessions rather than medication, side effects may include emotional discomfort or distress during discussions about personal experiences related to depression and perinatal loss.

HeAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 50 years old.
Select...
I am a woman diagnosed with major depressive disorder.

HeAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks after intake
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks after intake for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Major Depressive Disorder recovery
Secondary outcome measures
Complicated grief symptoms
Depressive symptoms
Dyadic social support (from partner or another important person)
+8 more
Other outcome measures
Treatment acceptability

HeAL Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Interpersonal psychotherapy for major depression following perinatal lossExperimental Treatment1 Intervention
Participants in the IPT condition will receive 12 group sessions and 2 individual (pre-group and 1-month booster) sessions as outlined in the manual The individual sessions prepare patients to use the group effectively, to keep group members focused on their treatment goals, and to maintain treatment gains. In addition, 3 of the 12 group sessions will invite women to include their partners or other support people to bolster the woman's social support system and to reduce conflicts over how to react to the loss. These sessions are important because relationship distress is common following perinatal loss. Our IPT intervention allows new women to enter the group every 4 weeks of the 12-week group. Group sessions are semi-structured, and each woman will cover the four group topics three times, approaching each topic from a different stage in the mourning process.
Group II: Coping with DepressionActive Control1 Intervention
The Coping with Depression (CWD) course is a structured, manualized psycho-educational group treatment for MDD. The CWD course is based on social learning theory which posits that depression is associated with a decrease in pleasant and an increase in unpleasant person-environment interactions. The problems shown by depressed individuals are viewed as behavioral, with cognitive patterns that can be unlearned or relearned. Its effectiveness is comparable to other forms of psychotherapy in depression. The course content is cognitive-behavioral in nature and is designed to train skills that can be used in the alleviation of depression. The skill modules focus on relaxation, cognitive skills, and behavioral activation. As in the pilot trial, CWD will consist of an individual pregroup session, 12 group therapy sessions (allowing new women to enter every 4th session) and a 1-month individual booster session to provide an identical treatment dose as the experimental condition.

Find a Location

Who is running the clinical trial?

Michigan State UniversityLead Sponsor
184 Previous Clinical Trials
601,153 Total Patients Enrolled
8 Trials studying Depression
4,101 Patients Enrolled for Depression
Women and Infants Hospital of Rhode IslandOTHER
108 Previous Clinical Trials
38,266 Total Patients Enrolled
9 Trials studying Depression
6,672 Patients Enrolled for Depression
Jennifer E Johnson, PhDPrincipal InvestigatorMichigan State University
3 Previous Clinical Trials
542,362 Total Patients Enrolled
1 Trials studying Depression
2,320 Patients Enrolled for Depression

Media Library

Interpersonal psychotherapy for major depression following perinatal loss Clinical Trial Eligibility Overview. Trial Name: NCT04629599 — Phase 2 & 3
Depression Research Study Groups: Interpersonal psychotherapy for major depression following perinatal loss, Coping with Depression
Depression Clinical Trial 2023: Interpersonal psychotherapy for major depression following perinatal loss Highlights & Side Effects. Trial Name: NCT04629599 — Phase 2 & 3
Interpersonal psychotherapy for major depression following perinatal loss 2023 Treatment Timeline for Medical Study. Trial Name: NCT04629599 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals outside of the age bracket of 45 years being recruited for this trial?

"The age parameters for this particular study are 18 to 50. Out of the 1290 total clinical trials, this one falls in the middle as 203 are for patients under 18 and 987 are for patients over 65."

Answered by AI

Are there specific eligibility requirements for potential participants of this trial?

"Qualified applicants for this clinical trial must have a major depressive disorder diagnosis and be between 18-50 years old. So far, the trial has accepted 274 participants."

Answered by AI

Are there any unfilled openings for this experiment?

"The trial, which was advertised on September 1st 2021, is still looking for patients according to the website clinicaltrials.gov. This information was last updated on June 10th, 2022."

Answered by AI
~102 spots leftby Nov 2025