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

Trial Summary

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 data supports the effectiveness of the treatment IMAGINE for perinatal depression?

The PRISM program, which shares similar goals with IMAGINE, showed that it might improve how healthcare providers screen for and manage perinatal depression, suggesting that structured support programs can be effective in addressing this condition. ^{1 2 3 4 5}

Is the treatment in the IMAGINE trial for perinatal depression safe for humans?

The research articles do not provide specific safety data for the treatment in the IMAGINE trial. However, they discuss the general use of antidepressants during pregnancy, noting that while no medication is entirely risk-free, many antidepressants, especially SSRIs (a type of antidepressant), are considered safer than leaving depression untreated during pregnancy. ^{6 7 8 9 10}

How is the IMAGINE treatment for perinatal depression different from other treatments?

The IMAGINE treatment for perinatal depression is unique because it incorporates mindfulness-based cognitive therapy, which is designed to be more accessible and appealing, especially for people who face barriers in traditional healthcare settings. ^{11 12 13 14 15}

What is the purpose of this trial?

The goal of this clinical trial is to evaluate if a digital group intervention (named IMAGINE) can prevent depression in perinatal populations. The main questions it aims to answer are: Does IMAGINE engage cognitive behavioral therapy targets? Does IMAGINE lead to lower depression scores? Is IMAGINE acceptable, appropriate, usable and feasible? Participants will be randomized to either participate in an IMAGINE group for 12 weeks or receive standard of care. Participants will respond to questionnaires at enrollment and study visits at 12 and 24 weeks after enrollment.

Research Team

Keshet Ronen, PhD, MPH

Principal Investigator

University of Washington

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Implementing Routine Screening and Referrals for Perinatal Mood Disorders in an Integrated Multi-site Pediatric and Obstetric Setting. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Important research outcomes for treatment studies of perinatal depression: systematic overview and development of a core outcome set. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Strategies for improving perinatal depression treatment in North American outpatient obstetric settings. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

PRogram In Support of Moms (PRISM): Development and Beta Testing. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Improving perinatal depression care: the Massachusetts Child Psychiatry Access Project for Moms. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Antepartum and postpartum depression: healthy mom, healthy baby. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Use of Antidepressants During Pregnancy?: What to Consider when Weighing Treatment with Antidepressants Against Untreated Depression. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Mamma Mia - A randomized controlled trial of an internet-based intervention for perinatal depression. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Examining the Prevalence of Peripartum Depressive Symptoms in a Border Community. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Perinatal Obstetric Office Depression Screening and Treatment: Implementation in a Health Care System. [2021]

11. Australia pubmed.ncbi.nlm.nih.gov

A national approach to perinatal mental health in Australia: exercising caution in the roll-out of a public health initiative. [2020]

12. Austria pubmed.ncbi.nlm.nih.gov

The EPDS-Lifetime: assessment of lifetime prevalence and risk factors for perinatal depression in a large cohort of depressed women. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Adapting Mindfulness-Based Cognitive Therapy for Perinatal Depression to Improve Access and Appeal of Preventive Care. [2023]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Prevalence and incidence of probable perinatal depression among women enrolled in Option B+ antenatal HIV care in Malawi. [2022]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of intervention delivered by frontline maternal care providers to improve outcome and parenting skills among adolescents with perinatal depression in Nigeria (the RAPiD study): A cluster randomized controlled trial. [2022]