Major Depressive DisorderHeALNCT04629599
IPT for Major Depression Following Perinatal Loss: Healing After Loss (HeAL)
A study testing Interpersonal psychotherapy for major depression following perinatal loss and Coping with Depression in people with Major Depressive Disorder, run by Michigan State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Interpersonal psychotherapy for major depression following perinatal loss and Coping with Depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Anywhere in the entire state of Michigan (treatment is virtual)
Flint, Michigan, 48502
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Interpersonal psychotherapy for major depression following perinatal loss, Coping with Depression
- Keywords
- Perinatal loss, Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal psychotherapy for major depression following perinatal lossBehavioural
Also called IPT
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 DepressionBehavioural
Also called CWD
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.
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal psychotherapy for major depression following perinatal loss | Experimental | 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. Receives: Behavioral: Interpersonal psychotherapy for major depression following perinatal loss |
| Coping with Depression | Active comparator | 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. Receives: Behavioral: Coping with Depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Major Depressive Disorder recovery
Assessed via the Longitudinal Interview Follow-up Evaluation (LIFE; lower is better)
Measured: censored at 28 weeks, the proposed study duration
Secondary outcomes (11)
Depressive symptoms
Overall score on the Quick Inventory of Depressive Symptoms (QIDS; lower is better)
Measured: 8, 16, and 28 weeks after intake
PTSD symptoms
Life Events Checklist and PTSD Checklist for DSM-5 (LEC-PCL; lower is better)
Measured: 8, 16, and 28 weeks after intake
Time to PTSD recovery
Assessed via the Longitudinal Interval Follow-Up Evaluation (LIFE; lower is better)
Measured: censored at 28 weeks, the proposed study duration
Overall perceived social support
Overall score of the Multidimensional Scale of Perceived Social Support (higher is better)
Measured: 8, 16, and 28 weeks after intake
Dyadic social support (from partner or another important person)
Overall score of the Relationship Assessment Scale (higher is better)
Measured: 8, 16, and 28 weeks after intake
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)
Measured: 8, 16, and 28 weeks after intake
Well-being
Overall score of the NIH Neuro-Quality of Life scale for positive affect and well-being (higher is better)
Measured: 8, 16, and 28 weeks after intake
Grief symptoms
Overall score of the Perinatal Bereavement Grief Scale (lower is better)
Measured: 8, 16, and 28 weeks after intake
Complicated grief symptoms
Overall score of the Inventory of Complicated Grief (lower is better)
Measured: 8, 16, and 28 weeks after intake
Perceived deservingness of loss and guilt over loss
Loss Beliefs Scale (lower is better)
Measured: 8, 16, an 28 weeks after intake
Fear of subsequent pregnancies
Overall score of the Fear of subsequent pregnancies measure (lower is better)
Measured: 8, 16, and 28 weeks after intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Aug 2021
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Women and Infants Hospital of Rhode Island
- Responsible party
- Principal investigator, Jennifer E. Johnson, Michigan State University
- Investigators
- Jennifer E Johnson, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629599
- Sponsor's protocol ID
- R01HD100471
- Acronym
- HeAL
- Status last verified
- Apr 2026
- First submitted
- 10 Nov 2020
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 27003141Johnson 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.
PubMed 35440458
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IPT for Major Depression Following Perinatal Loss: Healing After Loss (HeAL)
- ClinicalTrials.gov ID
- NCT04629599
- Acronym / sponsor ID
- HeAL / R01HD100471
- Conditions
- Major Depressive Disorder
- Keywords
- Perinatal loss, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Women and Infants Hospital of Rhode Island
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpersonal psychotherapy for major depression following perinatal loss | Experimental | Behavioral: Interpersonal psychotherapy for major depression following perinatal lossParticipants 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 | Active comparator | Behavioral: Coping with DepressionThe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpersonal psychotherapy for major depression following perinatal lossAlso: IPTParticipants 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. | Behavioural | Interpersonal psychotherapy for major depression following perinatal loss |
| Coping with DepressionAlso: CWDThe 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. | Behavioural | Coping with Depression |
Primary outcome
Time to Major Depressive Disorder recovery
Time frame: censored at 28 weeks, the proposed study duration
Assessed via the Longitudinal Interview Follow-up Evaluation (LIFE; lower is better)
11 secondary outcomes
Depressive symptoms
Time frame: 8, 16, and 28 weeks after intake
PTSD symptoms
Time frame: 8, 16, and 28 weeks after intake
Time to PTSD recovery
Time frame: censored at 28 weeks, the proposed study duration
Overall perceived social support
Time frame: 8, 16, and 28 weeks after intake
Dyadic social support (from partner or another important person)
Time frame: 8, 16, and 28 weeks after intake
Social role functioning (including parental functioning)
Time frame: 8, 16, and 28 weeks after intake
Well-being
Time frame: 8, 16, and 28 weeks after intake
Grief symptoms
Time frame: 8, 16, and 28 weeks after intake
Complicated grief symptoms
Time frame: 8, 16, and 28 weeks after intake
Perceived deservingness of loss and guilt over loss
Time frame: 8, 16, an 28 weeks after intake
Fear of subsequent pregnancies
Time frame: 8, 16, and 28 weeks after intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 27003141Johnson 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.
- Derived from this study: PubMed 35440458Johnson 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer E Johnson, PhD principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal psychotherapy for major depression following perinatal loss and Coping with Depression in people with Major Depressive Disorder, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Major Depressive Disorder recovery (time frame: censored at 28 weeks, the proposed study duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04629599, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.