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

Major Depressive Disorder Clinical Trial

— HeAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04629599
• Other study ID #: R01HD100471
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 1, 2021
• Est. completion date: November 1, 2025

Study information

• Verified date: June 2022
• Source: Michigan State University
• Contact: Jennifer E Johnson, PhD
• Phone: 810-600-5669
• Email: jjohns[@]msu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 274
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Interpersonal psychotherapy for major depression following perinatal loss
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.
• Coping with Depression
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.

Locations

Country	Name	City	State
United States	Anywhere in the entire state of Michigan (treatment is virtual)	Flint	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment acceptability	Client Satisfaction Questionnaire - Revised (CSQ-8-R; higher is better)	16 weeks after intake
Primary	Time to Major Depressive Disorder recovery	Assessed via the Longitudinal Interview Follow-up Evaluation (LIFE; lower is better)	censored at 28 weeks, the proposed study duration
Secondary	Depressive symptoms	Overall score on the Quick Inventory of Depressive Symptoms (QIDS; lower is better)	8, 16, and 28 weeks after intake
Secondary	PTSD symptoms	Life Events Checklist and PTSD Checklist for DSM-5 (LEC-PCL; lower is better)	8, 16, and 28 weeks after intake
Secondary	Time to PTSD recovery	Assessed via the Longitudinal Interval Follow-Up Evaluation (LIFE; lower is better)	censored at 28 weeks, the proposed study duration
Secondary	Overall perceived social support	Overall score of the Multidimensional Scale of Perceived Social Support (higher is better)	8, 16, and 28 weeks after intake
Secondary	Dyadic social support (from partner or another important person)	Overall score of the Relationship Assessment Scale (higher is better)	8, 16, and 28 weeks after intake
Secondary	Social role functioning (including parental functioning)	Overall score of the Short version of the Social Adjustment Scale (SAS) - Self Report and parental functioning SAS subscale (lower is better)	8, 16, and 28 weeks after intake
Secondary	Well-being	Overall score of the NIH Neuro-Quality of Life scale for positive affect and well-being (higher is better)	8, 16, and 28 weeks after intake
Secondary	Grief symptoms	Overall score of the Perinatal Bereavement Grief Scale (lower is better)	8, 16, and 28 weeks after intake
Secondary	Complicated grief symptoms	Overall score of the Inventory of Complicated Grief (lower is better)	8, 16, and 28 weeks after intake
Secondary	Perceived deservingness of loss and guilt over loss	Loss Beliefs Scale (lower is better)	8, 16, an 28 weeks after intake
Secondary	Fear of subsequent pregnancies	Overall score of the Fear of subsequent pregnancies measure (lower is better)	8, 16, and 28 weeks after intake