Psychotherapy for Postpartum Depression

Overseen By Maddy Schier

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Must be taking: Antidepressants

Must not be taking: Psychotropic drugs

Disqualifiers: Suicidal intent, Substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called Engage & Connect, designed to help women with postpartum depression feel less isolated and improve their mood. It compares this treatment to another approach that reviews symptoms and provides education about depression. Both treatments occur remotely over nine weeks and aim to reduce feelings of depression and loneliness. Women within a year of giving birth who feel persistently sad or isolated, even while on a steady dose of antidepressants, might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for postpartum depression.

Will I have to stop taking my current medications?

The trial requires that participants either be off antidepressants or on a stable dose for at least 8 weeks, with no plans to change the dose in the next 10 weeks. Other psychotropic drugs are generally not allowed, except for a small amount of lorazepam.

What prior data suggests that these psychotherapies are safe for postpartum depression?

Research shows that the Engage & Connect therapy is being tested for safety and effectiveness in treating postpartum depression. This 9-week, remote therapy aims to reduce feelings of social isolation and depression. Although detailed safety information for this specific therapy is still being gathered, its early trial phase indicates ongoing data collection.

Talk therapies like Engage & Connect are generally well-tolerated and have fewer side effects than medication-based treatments. As a type of talk therapy, Engage & Connect is expected to have a low risk of negative effects. Participants typically share their experiences during and after the therapy, helping researchers ensure the treatment's safety.

In summary, while detailed safety data on Engage & Connect is not yet available, talk therapies are generally considered safe. Participants can discuss any concerns with the study team to ensure they feel safe and comfortable during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Engage & Connect" treatment for postpartum depression because it offers a novel approach that differs from traditional methods like medication and standard talk therapy. This treatment focuses on enhancing social support and building connections, which are crucial for new mothers experiencing depression. The method emphasizes psychoeducation and symptom review, empowering women with knowledge and coping strategies tailored to their specific needs. By addressing the social and educational aspects of postpartum depression, "Engage & Connect" has the potential to provide more comprehensive and personalized support, making it a promising option for those seeking alternatives to medication.

What evidence suggests that this trial's treatments could be effective for postpartum depression?

Research has shown that Engage & Connect therapy, a treatment under study in this trial, improves social interactions, which is crucial for managing postpartum depression. This therapy aims to enhance the brain's reward system, which often functions poorly in women with postpartum depression. Early findings suggest that by targeting these reward systems, Engage & Connect can reduce feelings of loneliness and improve mood. Based on neuroscience, this therapy uses knowledge of brain function to enhance mental health. While researchers continue to gather data from larger studies, early results are promising for treating postpartum depression with this method. ^{1 2 3 4 6}

Who Is on the Research Team?

Nili Solomonov, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for new mothers 4-12 weeks post-delivery who are experiencing postpartum depression, as indicated by a score of ≥10 on the Edinburgh Postnatal Depression Scale. Participants should be either off antidepressants or on a stable dose for at least 8 weeks and speak English well. Those with severe psychiatric conditions other than certain anxiety disorders or specific phobias, using certain psychotropic drugs, or undergoing ongoing psychotherapy are excluded.

Inclusion Criteria

Speaks English proficiently

You scored 10 or higher on the Edinburgh Postnatal Depression Scale (EPDS).

I am able to understand and agree to the research and treatment plan.

Exclusion Criteria

I use no more than 0.5 mg of lorazepam daily or less.

You have a history of mental health conditions other than major depression, generalized anxiety, persistent depression, or specific phobias.

I am currently in psychotherapy, but not more than once every 8 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Engage & Connect psychotherapy or Symptom Review and Psychoeducation intervention remotely over 9 weeks

9 weeks

Weekly remote sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Engage & Connect

Trial Overview The study is testing 'Engage & Connect,' a new type of psychotherapy designed to help reduce postpartum depression. It involves 9 weeks of remote therapy sessions aimed at decreasing feelings of social isolation and improving how social rewards are processed, along with measuring changes in the severity of depression.

How Is the Trial Designed?

Group I: Symptom Review and Psychoeducation Experimental Treatment 1 Intervention

Group II: Engage & Connect Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

Postpartum depression affects 10% to 15% of new mothers, with even higher screening rates of 35% among African American women, highlighting the need for effective screening and intervention in primary care settings.

Effective treatments for perinatal depression include interpersonal psychotherapy and selective serotonin reuptake inhibitors, and timely mental health intervention can improve maternal well-being and prevent negative impacts on infant development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antepartum and postpartum depression: healthy mom, healthy baby. Moses-Kolko, EL., Roth, EK.[2021]

A case study of a first-time mother with postpartum depression showed that therapist-assisted internet-delivered cognitive behavior therapy (ICBT) led to significant symptom reduction over 12 weeks, indicating its potential efficacy for treating PPD.

The participant reported high treatment satisfaction and a strong therapeutic alliance with her therapist, suggesting that this approach could be a valuable option for clinicians working with women experiencing PPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet therapy for postpartum depression: a case illustration of emailed therapeutic assistance. Pugh, NE., Hadjistavropoulos, HD., Fuchs, CM.[2022]

An eight-week mindfulness-based cognitive therapy (MBCT) intervention showed promise as an adjunctive treatment for postpartum depression and anxiety, with participants experiencing significant decreases in their symptoms compared to a control group.

The study indicated that MBCT not only reduced depression and anxiety levels but also increased mindfulness, suggesting it could be a valuable non-pharmacological option for breastfeeding mothers who are hesitant to increase medication dosages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a mindfulness-based cognitive therapy group intervention as an adjunctive treatment for postpartum depression and anxiety. Shulman, B., Dueck, R., Ryan, D., et al.[2019]

This study will evaluate a blended cognitive-behavioral intervention for postpartum depression, combining face-to-face sessions with a web-based program, aiming to improve treatment accessibility for women who may not seek traditional help.

The trial will compare this blended intervention to usual care in healthcare centers, assessing various outcomes such as depressive symptoms, anxiety, and quality of life in Portuguese postpartum women, providing valuable data on its efficacy and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Blended Cognitive-Behavioral Intervention for the Treatment of Postpartum Depression: Study Protocol for a Randomized Controlled Trial. Branquinho, M., Canavarro, MC., Fonseca, A.[2021]

Psychotherapeutic interventions, particularly counseling, are effective as a standalone treatment for postpartum depression, making them a strong first-line option.

Unlike medication, psychotherapy poses no risks to breastfeeding infants, and there is emerging evidence that it may also help prevent postpartum depression, although further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevention and psychotherapeutic treatment of postpartum depression. Stuart, S., O'Hara, MW., Gorman, LL.[2016]

Mother-infant psychotherapy has been shown to significantly reduce depressive symptoms in mothers in the short term, with a standardized mean difference of -0.25 based on 13 randomized controlled trials.

However, the therapy did not demonstrate long-term benefits for maternal mood, mother-infant interaction, or infant attachment, indicating that while it may help initially, further research is needed to understand its lasting effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The short- and long-term effectiveness of mother-infant psychotherapy on postpartum depression: A systematic review and meta-analysis. Huang, R., Yang, D., Lei, B., et al.[2020]

Interpersonal psychotherapy (IPT) has been shown to significantly improve symptoms of postpartum depression (PPD), with evidence from 11 clinical trials indicating overall clinical improvement and often full recovery in treated patients.

IPT can effectively shorten the time to recovery from PPD and help maintain longer periods of clinical remission, whether used alone or in combination with antidepressants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interpersonal psychotherapy for postpartum depression: a systematic review. Miniati, M., Callari, A., Calugi, S., et al.[2022]

Group Interpersonal Psychotherapy (IPT-G) is an effective, structured approach for treating postnatal depression (PND), focusing on the social and relational challenges faced by new mothers.

A randomized controlled trial supports the efficacy of IPT-G, highlighting its strengths in addressing attachment styles and social isolation during the transition to parenthood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development and content of an interpersonal psychotherapy group for postnatal depression. Reay, RE., Mulcahy, R., Wilkinson, RB., et al.[2012]

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]

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]

A pilot trial involving 16 postpartum couples showed that a family-based treatment for postpartum depression (PPD) was highly acceptable and feasible, with high session attendance and positive participant feedback.

Both mothers and fathers experienced improvements in depression symptoms and family functioning, suggesting that involving family members in PPD treatment could enhance outcomes and warrant further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family treatment for postpartum depression: acceptability, feasibility, and preliminary clinical outcomes. Battle, CL., Cardemil, EV., Rossi, R., et al.[2023]

Mother-infant interaction is crucial in treating postpartum depression, as infants are highly sensitive to their mothers' emotional states, which can significantly impact their development.

The paper discusses the need for tailored psychotherapeutic approaches for young mothers and presents an integrated treatment model that focuses on both the mother and infant to effectively address postpartum depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychotherapy for postpartum depression with a focus on mother-infant interaction]. Reck, C., Weiss, R., Fuchs, T., et al.[2018]

Both mother-infant psychotherapy and interpersonal psychotherapy significantly reduced maternal depressive symptoms compared to a waiting-list group, highlighting their efficacy in treating postpartum depression.

These therapies also improved mothers' perceptions of their infants and increased positive interactions, emphasizing the importance of early intervention for mothers experiencing major depression after childbirth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotherapy for postpartum depression: a preliminary report. Clark, R., Tluczek, A., Wenzel, A.[2022]

Citations

1. 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.

2. jcto.weill.cornell.edu jcto.weill.cornell.edu/open_clinical_trials/engage-connect-a-novel-neuroscience-informed-streamlined-psychotherapy-for-postpartum-depression

Engage & Connect: A novel, neuroscience-informed ... This study will test the effectiveness of Engage & Connect, a 9-week remotely delivered psychotherapy for postpartum depression that focuses on reducing ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05585164

Engage & Connect: A Psychotherapy for Postpartum ... Details for study NCT05585164, | ClinicalTrials.gov.

4. osf.io osf.io/n4p75/download/?format=pdf

Engage & Connect psychotherapy improves social reward ... Women with PPD experience disruptions in reward-supported behaviors - reduced behavioral activation and social reward responsivity. Thus, the reward system is a ...

5. withpower.com withpower.com/trial/phase-depression-9-2022-2d1af

Psychotherapy for Postpartum Depression This N/A medical study run by Weill Medical College of Cornell University is evaluating whether Engage & Connect will have tolerable side effects & efficacy ...

6. psychiatry.weill.cornell.edu psychiatry.weill.cornell.edu/join-our-treatment-studies

Join Our Treatment Studies Antidepressant Medication Study for Older Adults with DepressionPersistent Sadness… Loss of Interests and Pleasure… Low Energy or Sleeplessness…