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

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Interpersonal psychotherapy for major depression following perinatal loss
Coping with Depression
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Perinatal loss, Depression

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Anywhere in the entire state of Michigan (treatment is virtual)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interpersonal psychotherapy for major depression following perinatal loss

Coping with Depression

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to Major Depressive Disorder recovery
Assessed via the Longitudinal Interview Follow-up Evaluation (LIFE; lower is better)

Secondary Outcome Measures

Depressive symptoms
Overall score on the Quick Inventory of Depressive Symptoms (QIDS; lower is better)
PTSD symptoms
Life Events Checklist and PTSD Checklist for DSM-5 (LEC-PCL; lower is better)
Time to PTSD recovery
Assessed via the Longitudinal Interval Follow-Up Evaluation (LIFE; lower is better)
Overall perceived social support
Overall score of the Multidimensional Scale of Perceived Social Support (higher is better)
Dyadic social support (from partner or another important person)
Overall score of the Relationship Assessment Scale (higher is better)
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)
Well-being
Overall score of the NIH Neuro-Quality of Life scale for positive affect and well-being (higher is better)
Grief symptoms
Overall score of the Perinatal Bereavement Grief Scale (lower is better)
Complicated grief symptoms
Overall score of the Inventory of Complicated Grief (lower is better)
Perceived deservingness of loss and guilt over loss
Loss Beliefs Scale (lower is better)
Fear of subsequent pregnancies
Overall score of the Fear of subsequent pregnancies measure (lower is better)

Full Information

First Posted
November 10, 2020
Last Updated
June 26, 2023
Sponsor
Michigan State University
Collaborators
Women and Infants Hospital of Rhode Island
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1. Study Identification

Unique Protocol Identification Number
NCT04629599
Brief Title
IPT for Major Depression Following Perinatal Loss: Healing After Loss (HeAL)
Acronym
HeAL
Official Title
IPT for Major Depression Following Perinatal Loss: Healing After Loss (HeAL)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
Women and Infants Hospital of Rhode Island

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Perinatal loss, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
274 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interpersonal psychotherapy for major depression following perinatal loss
Arm Type
Experimental
Arm Description
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.
Arm Title
Coping with Depression
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal psychotherapy for major depression following perinatal loss
Other Intervention Name(s)
IPT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Coping with Depression
Other Intervention Name(s)
CWD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Major Depressive Disorder recovery
Description
Assessed via the Longitudinal Interview Follow-up Evaluation (LIFE; lower is better)
Time Frame
censored at 28 weeks, the proposed study duration
Secondary Outcome Measure Information:
Title
Depressive symptoms
Description
Overall score on the Quick Inventory of Depressive Symptoms (QIDS; lower is better)
Time Frame
8, 16, and 28 weeks after intake
Title
PTSD symptoms
Description
Life Events Checklist and PTSD Checklist for DSM-5 (LEC-PCL; lower is better)
Time Frame
8, 16, and 28 weeks after intake
Title
Time to PTSD recovery
Description
Assessed via the Longitudinal Interval Follow-Up Evaluation (LIFE; lower is better)
Time Frame
censored at 28 weeks, the proposed study duration
Title
Overall perceived social support
Description
Overall score of the Multidimensional Scale of Perceived Social Support (higher is better)
Time Frame
8, 16, and 28 weeks after intake
Title
Dyadic social support (from partner or another important person)
Description
Overall score of the Relationship Assessment Scale (higher is better)
Time Frame
8, 16, and 28 weeks after intake
Title
Social role functioning (including parental functioning)
Description
Overall score of the Short version of the Social Adjustment Scale (SAS) - Self Report and parental functioning SAS subscale (lower is better)
Time Frame
8, 16, and 28 weeks after intake
Title
Well-being
Description
Overall score of the NIH Neuro-Quality of Life scale for positive affect and well-being (higher is better)
Time Frame
8, 16, and 28 weeks after intake
Title
Grief symptoms
Description
Overall score of the Perinatal Bereavement Grief Scale (lower is better)
Time Frame
8, 16, and 28 weeks after intake
Title
Complicated grief symptoms
Description
Overall score of the Inventory of Complicated Grief (lower is better)
Time Frame
8, 16, and 28 weeks after intake
Title
Perceived deservingness of loss and guilt over loss
Description
Loss Beliefs Scale (lower is better)
Time Frame
8, 16, an 28 weeks after intake
Title
Fear of subsequent pregnancies
Description
Overall score of the Fear of subsequent pregnancies measure (lower is better)
Time Frame
8, 16, and 28 weeks after intake
Other Pre-specified Outcome Measures:
Title
Treatment acceptability
Description
Client Satisfaction Questionnaire - Revised (CSQ-8-R; higher is better)
Time Frame
16 weeks after intake

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Adult women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer E Johnson, PhD
Phone
810-600-5669
Email
jjohns@msu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer E Johnson, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anywhere in the entire state of Michigan (treatment is virtual)
City
Flint
State/Province
Michigan
ZIP/Postal Code
48502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Lamphere, MSW
Phone
810-516-0319
Email
heal@msu.edu
First Name & Middle Initial & Last Name & Degree
Susan Lamphere, MSU
Phone
810-600-5672
Email
Lamphe14@msu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
This project will meet NICHD's timelines and requirements for depositing relevant de-identified data into relevant national databases. This will be reflected in study consent forms. De-identified data will be also made available to qualified researchers upon request, on a compact disk (CD) or other electronic means compatible with our systems. The request will be evaluated by the Principal Investigator to ensure that it meets reasonable standards of scientific integrity.
IPD Sharing Time Frame
Data sharing will occur on NIH-designated timelines.
IPD Sharing Access Criteria
Request needs to meet reasonable standards of scientific integrity, as judged by the Study Principal Investigator
Citations:
PubMed Identifier
27003141
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.
Results Reference
background
PubMed Identifier
35440458
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.
Results Reference
derived

Learn more about this trial

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

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