IMAGINE for Perinatal Depression

Overseen By Jaclyn Escudero, MPH

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Major depression, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new digital group intervention called IMAGINE, designed to help prevent depression in individuals who are pregnant or recently had a baby. The researchers aim to determine if IMAGINE can engage key therapy targets, reduce depression symptoms, and remain easy and practical for users. Participants will either join a 12-week IMAGINE group session or receive standard care, with follow-up questionnaires tracking progress. This trial suits those who are pregnant or up to 6 months postpartum, at risk for depression, and have regular smartphone access. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could shape future mental health support for new and expecting parents.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, if you are receiving other mental healthcare services, you must have been on a stable treatment regimen for at least 6 months.

What prior data suggests that the IMAGINE digital group intervention is safe for perinatal populations?

Research shows that the IMAGINE program, a digital group activity for new and expecting mothers with depression, is safe and easy to use. A small study found that participants liked the program and found it helpful. These studies reported no major safety issues.

The IMAGINE program is based on the "Mothers and Babies" program, which has proven effective in reducing stress and depression. As an online version of this successful program, IMAGINE is expected to be safe for participants. Overall, current evidence suggests the program is safe for use by new and expecting mothers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IMAGINE treatment for perinatal depression because it offers a digital, interactive adaptation of the proven Mothers and Babies program. Unlike traditional therapies that may rely on in-person sessions, IMAGINE allows perinatal individuals to receive support in a group setting facilitated by a mental health provider through an online platform. This approach increases accessibility and convenience, making it easier for new parents to get the help they need without leaving home. By harnessing digital technology, IMAGINE has the potential to reach a wider audience and provide timely, effective support for managing perinatal depression.

What evidence suggests that the IMAGINE digital group intervention is effective for preventing perinatal depression?

Research shows that the IMAGINE program, which participants in this trial may receive, is an online version of the Mothers and Babies course, a proven method to prevent depression during and after pregnancy. The original Mothers and Babies program uses cognitive behavioral therapy (CBT), which helps people change negative thinking patterns. Studies have shown that CBT effectively reduces depression symptoms. Early results suggest that digital versions like IMAGINE are well-received and helpful for participants. Thus, IMAGINE might reduce depression in pregnant and new mothers by using these proven techniques. ^{1 2 3 5 6}

Who Is on the Research Team?

Keshet Ronen, PhD, MPH

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for pregnant or postpartum individuals (up to 6 months after birth), aged 16+, at risk of perinatal depression but not currently experiencing major depression. Participants must speak English or Spanish, have stable mental healthcare if any, and access to a smartphone with data.

Inclusion Criteria

Access to a smartphone with cellular data at least 3 days per week

At elevated risk of perinatal depression (per USPSTF)

My depression score is low and I'm not currently severely depressed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either participate in the IMAGINE group for 12 weeks or receive standard of care.

12 weeks

1 visit (enrollment), 1 visit (12 weeks post-enrollment)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (24 weeks post-enrollment)

What Are the Treatments Tested in This Trial?

Interventions

• IMAGINE

Trial Overview The IMAGINE digital group intervention aims to prevent perinatal depression using cognitive behavioral therapy techniques. The study compares IMAGINE over a 12-week period against standard care, measuring engagement, effectiveness on lowering depression scores, and user satisfaction.

How Is the Trial Designed?

Group I: IMAGINE Experimental Treatment 1 Intervention

The intervention is a digital adaptation of the evidence-based Mothers and Babies program, delivered interactively to groups of perinatal people and facilitated by a mental health provider.

Group II: Control Active Control 1 Intervention

Control participants will be provided with standardized information about signs and symptoms of perinatal depression and will continue to receive standard healthcare.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Seattle Children's Research Institute

Collaborator

Trials

2

Recruited

180+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Perinatal depression significantly contributes to preventable health issues during and after childbirth, yet effective and accessible treatment options are limited, especially for marginalized groups.

The authors are piloting a new intervention called Center M, which adapts Mindfulness-Based Cognitive Therapy to improve access and appeal for preventing perinatal depression, addressing barriers in standard prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting Mindfulness-Based Cognitive Therapy for Perinatal Depression to Improve Access and Appeal of Preventive Care. Tilden, EL., Holmes, LR., Vasquez Guzman, CE., et al.[2023]

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]

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06746337

IMAGINE: Pilot Trial of a Digital Group Intervention to ... Details for study NCT06746337, | ClinicalTrials.gov.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10873795/

Acceptability and Utility of a Digital Group Intervention to ... The Mothers and Babies Course (MB) is an evidence-based intervention for the prevention of perinatal depression, grounded in cognitive behavioral therapy, ...

4. formative.jmir.org formative.jmir.org/2024/1/e51066

Acceptability and Utility of a Digital Group Intervention to ... Background: Perinatal depression (depression during pregnancy or the first year postpartum) affects 10%-25% of perinatal individuals, ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38306159/

Acceptability and Utility of a Digital Group Intervention to ... Division of Adolescent Medicine, Seattle Children's Hospital, Seattle, WA, United States. 3 Department of Obstetrics and Gynecology, Warren ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032722008011

Results from an effectiveness-implementation evaluation of ... Mothers and Babies 1-on-1 delivered by lay home visitors leads to reductions in perceived stress and depressive symptoms.