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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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 50 years old.

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I am a woman diagnosed with major depressive disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks after intake

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to Major Depressive Disorder recovery

Secondary study objectives

Complicated grief symptoms

Depressive symptoms

Dyadic social support (from partner or another important person)

+8 more

Other study objectives

Treatment acceptability

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met