Interpersonal Psychotherapy for Depression After Perinatal Loss

(HeAL Trial)

Recruiting at 2 trial locations

Overseen By Jennifer E Johnson, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Michigan State University

Must not be taking: Antidepressants

Disqualifiers: Bipolar, Schizophrenia, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of interpersonal psychotherapy (IPT) for women experiencing major depression after losing a baby during or soon after pregnancy. IPT aims to improve relationships and social support, aiding in coping with grief and depression. Participants will attend group therapy sessions and some individual sessions, with the option to involve partners or other support people. Women who have experienced perinatal loss and are currently dealing with major depression may be suitable for this study. As an unphased study, this trial provides a unique opportunity to explore new methods for managing grief and depression with professional support.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must have a stable course of antidepressant medication, meaning no changes in the dose for at least 12 weeks before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that interpersonal psychotherapy (IPT) is generally safe and well-tolerated for treating major depression. This therapy has been adapted for women who have experienced the loss of a baby during pregnancy. Studies have found that IPT is both feasible and acceptable for individuals dealing with this type of depression, potentially aiding in better coping.

As a form of talk therapy, IPT lacks the physical side effects that medications might cause. Instead, it enhances personal relationships and communication skills, which can greatly benefit those facing depression.

For those considering joining a trial involving IPT, current evidence suggests it is a safe option for managing major depression after losing a baby during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Interpersonal Psychotherapy (IPT) for major depression following perinatal loss because it focuses on enhancing social support, which is crucial during the mourning process. Unlike typical treatments that might involve medication or traditional cognitive therapy, IPT includes group sessions where participants can bring partners or support people to help improve relationship dynamics and reduce conflicts after a loss. This unique approach not only addresses the emotional aspects of depression but also strengthens the social bonds that are vital for recovery.

What evidence suggests that interpersonal psychotherapy might be an effective treatment for depression following perinatal loss?

Research has shown that interpersonal psychotherapy (IPT), one of the treatments studied in this trial, is a promising approach for major depression, especially after losing a baby. Studies have found that IPT reduces symptoms of postpartum depression, which resembles depression after such a loss. This therapy focuses on improving relationships and social support, crucial for those grieving. It has proven practical and well-received by individuals dealing with depression after losing a baby. Additionally, IPT has effectively helped people recover from major depressive disorder (MDD) by enhancing their relationships and communication. Overall, these findings suggest that IPT could be a valuable tool for managing depression in this specific situation. ^{1 2 4 6 7}

Who Is on the Research Team?

Jennifer E Johnson, PhD

Principal Investigator

Michigan State University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

speak and understand English well enough to understand questionnaires when they are read aloud

I am a woman diagnosed with major depressive disorder.

have access to a telephone through owning one, a relative/friend, or an agency

Exclusion Criteria

You are at immediate risk of hurting yourself or others.

You currently have an addiction to drugs or alcohol as your main health issue.

You have been diagnosed with bipolar disorder, schizophrenia, or any other mental disorder that causes hallucinations or delusions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 group sessions and 2 individual sessions of interpersonal psychotherapy (IPT) for major depression following perinatal loss

12 weeks

12 group sessions, 2 individual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 8, 16, and 28 weeks

16 weeks

3 follow-up assessments

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview 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.

How Is the Trial Designed?

Group I: Interpersonal psychotherapy for major depression following perinatal loss Experimental Treatment 1 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 Depression Active Control 1 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.

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials

202

Recruited

687,000+

Women and Infants Hospital of Rhode Island

Collaborator

Trials

119

Recruited

59,200+

Published Research Related to This Trial

Interpersonal psychotherapy (IPT) is supported by strong evidence as an effective treatment for postpartum depression (PPD), focusing on the interpersonal challenges women face after childbirth.

IPT is delivered in 12 sessions and is particularly relevant for addressing issues like role transitions and interpersonal disputes, making it a practical and effective option for primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An approach to interpersonal psychotherapy for postpartum depression: focusing on interpersonal changes. Grigoriadis, S., Ravitz, P.[2022]

Interpersonal psychotherapy (IPT) is effective in reducing symptoms of depression and anxiety in perinatal women, based on a systematic review of 45 studies, including 25 randomized controlled trials.

IPT not only alleviates psychological distress but also enhances social support and relationship quality, making it a valuable intervention during pregnancy and up to 12 months postpartum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interpersonal Psychotherapy to Reduce Psychological Distress in Perinatal Women: A Systematic Review. Bright, KS., Charrois, EM., Mughal, MK., et al.[2021]

Interpersonal psychotherapy (IPT) is effective in preventing and treating perinatal depression, significantly reducing depressive symptoms and the prevalence of depressive episodes based on a systematic review of 28 studies.

In addition to depression, IPT also shows promise in reducing anxiety symptoms and improving relationship quality, social adjustment, and social support during the perinatal period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of interpersonal psychotherapy for perinatal women. Sockol, LE.[2019]

Interpersonal psychotherapy (IPT) has been effectively adapted for treating depression in elderly patients, particularly those experiencing grief from the loss of a spouse.

In a preliminary study of 6 geriatric patients, IPT led to a significant reduction in depression scores on the Hamilton Rating Scale, from an average of 18.5 to 7.2 after about 17 sessions, indicating its efficacy as a short-term treatment for bereavement-related depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying interpersonal psychotherapy to bereavement-related depression following loss of a spouse in late life. Miller, MD., Frank, E., Cornes, C., et al.[2021]

This study will be the first large-scale randomized trial assessing the effectiveness of interpersonal psychotherapy (IPT) specifically for women experiencing major depressive disorder after perinatal loss, involving 274 participants from Michigan.

The trial aims to evaluate not only the recovery from depression but also PTSD symptoms and other related outcomes, with assessments occurring at multiple time points to track progress and the impact of IPT on social support and grief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the Healing After Loss (HeAL) Study: a randomised controlled trial of interpersonal psychotherapy (IPT) for major depression following perinatal loss. Johnson, JE., Price, AB., Sikorskii, A., et al.[2022]

The study involved 50 women who experienced perinatal loss and tested an adapted interpersonal psychotherapy (IPT) for its feasibility and preliminary efficacy, showing that IPT was well-accepted and led to higher satisfaction compared to a cognitive behavioral treatment.

IPT demonstrated potential effectiveness in reducing depressive symptoms and improving social support and grief symptoms, suggesting it could be a valuable intervention for women dealing with major depressive disorder after perinatal loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interpersonal psychotherapy (IPT) for major depression following perinatal loss: a pilot randomized controlled trial. Johnson, JE., Price, AB., Kao, JC., et al.[2022]

A group-based interpersonal psychotherapy (IPT) approach significantly reduced depression scores in 17 women diagnosed with postpartum depression, showing both immediate and lasting effects over a 6-month follow-up.

The study suggests that group IPT can be an effective treatment for postpartum depression, although limitations such as small sample size and lack of a control group may affect the reliability of the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interpersonal psychotherapy adapted for the group setting in the treatment of postpartum depression. Klier, CM., Muzik, M., Rosenblum, KL., et al.[2018]

Citations

1. womensmentalhealth.org womensmentalhealth.org/posts/interpersonal-therapy-effective-moderately-severe-postpartum-depression/

Interpersonal Therapy Effective for Moderately Severe ... Michael o'Hara and Scott Stuart were the first to demonstrate the effectiveness of this psychotherapy for the treatment of postpartum depression. Since that ...

2. samhsa.gov samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6372988/

Interpersonal Psychotherapy (IPT) for Major Depression ... This group IPT treatment adapted for MDD after perinatal loss is feasible, acceptable, and possibly efficacious. Keywords: depression, major depressive disorder ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04629599

Study Details | NCT04629599 | IPT for Major Depression ... 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 ( ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9020310/

Protocol for the Healing After Loss (HeAL) Study This protocol describes a study testing the efficacy of interpersonal psychotherapy (IPT) for major depressive disorder following perinatal loss.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2212657024000345

Pilot study of a perinatal interpersonal psychotherapy ... This is the first perinatal interpersonal psychotherapy group (P-IPTG) implemented for distressed women from pregnancy to postpartum.

7. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-019-1158-6

Interpersonal psychotherapy for perinatal women Interpersonal psychotherapy (IPT) is an intervention that has established efficacy in the prevention and treatment of depressive disorders.