In-Person vs. Virtual Therapy for Postpartum Depression

Overseen By Galena Rhoades, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Denver

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

Compensation: Varies

Number of Visits: 10

Duration: 5 weeks

900 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the ROSE Program treatment for postpartum depression?

The ROSE Program, which is a group educational intervention, has been shown to reduce cases of postpartum depression in community prenatal settings, especially among low-income pregnant women. Additionally, online interventions and workshops based on cognitive behavioral therapy have been found to improve postpartum depression symptoms, suggesting that virtual adaptations of the ROSE Program could also be effective. ^{1 2 3 4 5}

Is the ROSE Program safe for humans?

The ROSE Program, which is a group educational intervention to prevent postpartum depression, has been studied in various settings and has shown positive outcomes without any reported safety concerns for participants. ^{1 2 3 6 7}

How is the ROSE Program treatment for postpartum depression different from other treatments?

The ROSE Program is unique because it offers both in-person and virtual therapy options, providing flexibility and accessibility for new mothers. This program focuses on supporting mothers of newborns through a structured approach, which may include elements like cognitive-behavioral therapy, to improve mental health and the mother-infant relationship. ^{1 3 4 8 9}

What is the purpose of this trial?

The goal of this clinical trial is to test whether an established preventive intervention (group interpersonal therapy) delivered virtually shows the same benefits for preventing postpartum depression as it does when delivered in person.

Research Team

Galena Rhoades, PhD

Principal Investigator

University of Denver

Elysia P Davis, PhD

Principal Investigator

University of Denver

Eligibility Criteria

This trial is for English or Spanish-speaking individuals who are less than 30 weeks into their pregnancy. It's designed to help prevent postpartum depression and there are no specific exclusion criteria, meaning it's quite open for participants.

Inclusion Criteria

Less than 30 gestational weeks

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ROSE program, consisting of four 90-minute weekly group sessions and one individual booster session, delivered either in-person or virtually

5 weeks

4 group sessions (in-person or virtual), 1 individual session

Follow-up

Participants are monitored for depression levels using surveys and electronic health records at multiple time points postpartum

12 months

Surveys at 6 weeks, 3, 6, and 12 months postpartum

Treatment Details

Interventions

• ROSE Program: In Person
• ROSE Program: Virtual

Trial Overview The study is comparing the effectiveness of a group therapy program called ROSE in preventing postpartum depression when delivered in two ways: face-to-face (in person) and over the internet (virtually).

Participant Groups

Group I: Virtual Delivery of Group Preventative Intervention (ROSE) Experimental Treatment 1 Intervention

In parallel to ROSE delivered in person, virtual ROSE consists of four 90-minute, weekly group sessions conducted via Zoom and one individual booster session.

Group II: In-Person Delivery of Group Preventative Intervention (ROSE) Active Control 1 Intervention

The Reach Out, Stay Strong, Essentials for New Mothers Program (ROSE), is an established Interpersonal Therapy (IPT)-oriented group intervention for postpartum depression. ROSE is a brief (5-session) program and its content addresses social support, role transition to motherhood, communication skills, and psychoeducation on PPD. ROSE consists of four 90-minute, weekly in person group sessions and one individual booster session. The first four sessions of ROSE will be delivered in groups of 6 to 20, and conducted in both English and Spanish. For the in-person groups, transportation via Uber will be provided to Denver Health Medical Center to reduce barriers to attendance.

ROSE Program: In Person is already approved in United States for the following indications:

Approved in United States as ROSE Program for:

• Prevention of postpartum depression

Who Is Running the Clinical Trial?

University of Denver

Lead Sponsor

Trials

25

Recruited

10,600+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Denver Health Medical Center

Collaborator

Trials

13

Recruited

5,600+

Findings from Research

A one-day online workshop utilizing cognitive behavioral therapy significantly improved symptoms of postpartum depression and anxiety, as well as enhancing social support and the mother-infant relationship.

This approach offers an efficient way to increase access to treatment for postpartum depression, suggesting it could be a valuable addition to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Day Workshop Beneficial for Postpartum Depression. Rosenberg, K.[2022]

The ROSE sustainment (ROSES) study is evaluating the effectiveness and cost-effectiveness of a stepwise approach to sustaining a postpartum depression prevention program in 90 outpatient clinics, aiming to reduce postpartum depression rates among low-income pregnant women.

This study is the first randomized trial to assess the return on investment (ROI) of sustainment strategies in implementation science, which will provide valuable insights into maintaining effective interventions in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the ROSE sustainment (ROSES) study, a sequential multiple assignment randomized trial to determine the minimum necessary intervention to maintain a postpartum depression prevention program in prenatal clinics serving low-income women. Johnson, JE., Wiltsey-Stirman, S., Sikorskii, A., et al.[2023]

A new internet-based cognitive behavioral therapy (CBT) intervention combined with peer support was developed to prevent postpartum depression (PPD) and showed promising results, with only 4% of participants meeting the criteria for PPD at 6 weeks postpartum.

The study involved 25 pregnant women with mild depressive symptoms, and both the peer-supported and individual internet interventions effectively reduced depression symptoms, indicating that peer support may enhance adherence to online treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Group-Based Online Intervention to Prevent Postpartum Depression (Sunnyside): Feasibility Randomized Controlled Trial. Duffecy, J., Grekin, R., Hinkel, H., et al.[2020]

Therapist-assisted internet cognitive behavior therapy (TAICBT) is viewed positively by most women with postpartum depression (PPD), offering benefits like flexibility, accessibility, and enhanced self-awareness, based on feedback from 24 participants.

Despite the overall positive reception, some women faced challenges such as time management and the lack of face-to-face interaction, highlighting areas for improvement in future TAICBT programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Client experiences of guided internet cognitive behavior therapy for postpartum depression: a qualitative study. Pugh, NE., Hadjistavropoulos, HD., Hampton, AJD., et al.[2022]

A telephone-based screening protocol for postpartum depression (PPD) was developed and implemented, successfully identifying symptoms in 52% of women screened between 2 and 3 weeks postpartum.

The protocol led to high acceptance rates for referrals, with 64% of women accepting both provider and support services, and follow-through rates of 89% for provider referrals and 78% for support referrals, highlighting the efficacy of early screening and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uncovering the Golden Veil: Applying the Evidence for Telephone Screening to Detect Early Postpartum Depression. BenDavid, DN., Hunker, DF., Spadaro, KC.[2020]

The ROSE intervention, which focuses on strengthening social support and interpersonal skills, led to a significantly longer duration of breastfeeding among low-income women, with a median of 54 days compared to 21 days in the standard care group.

While both groups had similar rates of breastfeeding initiation, the ROSE program's emphasis on self-care and assertive help-seeking may enhance breastfeeding outcomes during the transition to motherhood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Positive Effect of a Group Intervention to Reduce Postpartum Depression on Breastfeeding Outcomes in Low-Income Women. Kao, JC., Johnson, JE., Todorova, R., et al.[2018]

The ROSE postpartum depression prevention program will be tested on 2320 pregnant individuals to evaluate its effectiveness as a universal prevention strategy, compared to selective or indicated prevention methods.

This study aims to provide insights into the cost-effectiveness, equity, and scalability of the ROSE program, making it the largest trial of its kind to date, which could influence future guidelines on postpartum depression prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for the ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression prevention. Johnson, JE., Loree, AM., Sikorskii, A., et al.[2023]

A randomized controlled trial with 183 participants showed that a 9-week online group cognitive-behavioral therapy (CBT) led by peers significantly reduced postpartum depression (PPD) and anxiety symptoms, with improvements lasting for at least 3 months after the intervention.

The study also found enhancements in maternal social support and reductions in infant-focused anxiety and negative emotionality, suggesting that this peer-delivered approach could effectively increase access to treatment for PPD and benefit families overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online peer-delivered group cognitive-behavioral therapy for postpartum depression: A randomized controlled trial. Merza, D., Amani, B., Savoy, C., et al.[2023]

A 9-week group cognitive-behavioral therapy (CBT) intervention delivered by peers significantly reduced symptoms of postpartum depression (PPD) and anxiety in 73 mothers, with improvements remaining stable at a 6-month follow-up.

The intervention also enhanced mother-infant bonding and reduced feelings of rejection and anger, suggesting it not only addresses mental health symptoms but also improves the overall mother-infant relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-Delivered Cognitive-Behavioral Therapy for Postpartum Depression: A Randomized Controlled Trial. Amani, B., Merza, D., Savoy, C., et al.[2022]

References

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

One-Day Workshop Beneficial for Postpartum Depression. [2022]

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

Protocol for the ROSE sustainment (ROSES) study, a sequential multiple assignment randomized trial to determine the minimum necessary intervention to maintain a postpartum depression prevention program in prenatal clinics serving low-income women. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

A Group-Based Online Intervention to Prevent Postpartum Depression (Sunnyside): Feasibility Randomized Controlled Trial. [2020]

4. Austria pubmed.ncbi.nlm.nih.gov

Client experiences of guided internet cognitive behavior therapy for postpartum depression: a qualitative study. [2022]

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

Uncovering the Golden Veil: Applying the Evidence for Telephone Screening to Detect Early Postpartum Depression. [2020]

6. England pubmed.ncbi.nlm.nih.gov

The Positive Effect of a Group Intervention to Reduce Postpartum Depression on Breastfeeding Outcomes in Low-Income Women. [2018]

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

Study protocol for the ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression prevention. [2023]

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

Online peer-delivered group cognitive-behavioral therapy for postpartum depression: A randomized controlled trial. [2023]

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

Peer-Delivered Cognitive-Behavioral Therapy for Postpartum Depression: A Randomized Controlled Trial. [2022]