250 Participants NeededMy employer runs this trial

Digital Therapy for Postpartum Depression

(HARMONY Trial)

EC
Overseen ByEliza Congdon, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if digital data from phones and watches can better predict treatment effectiveness for postpartum depression compared to self-reported symptoms alone. Participants will engage in a specialized online therapy program for postpartum depression, receiving coaching or clinical care based on symptom severity. The study targets women who are late in pregnancy or recently postpartum, experiencing moderate to severe depression, and not currently receiving mental health treatment. As an unphased trial, this research provides a unique opportunity to contribute to innovative methods for enhancing mental health care.

Do I have to stop taking my current medications for the trial?

The trial does not specify whether you need to stop taking your current medications. However, if you are currently receiving treatment by a therapist or psychiatrist, you are not eligible to participate.

What prior data suggests that this digital therapy and sensing method is safe for postpartum depression treatment?

Research has shown that digital therapy, such as online cognitive behavioral therapy (CBT), is generally well-received by individuals with postpartum depression. Studies have found that internet-based CBT effectively lessens symptoms of postnatal depression. This method is considered safe because it avoids the side effects often associated with medication.

One study discovered that digital CBT for postpartum depression works as well as in-person therapy, with participants experiencing fewer depressive symptoms after treatment. Another report notes that digital CBT is popular among users, who appreciate its convenience and easy access.

In summary, digital therapy with coaching appears safe and well-liked by users, making it a promising option for treating postpartum depression.12345

Why are researchers excited about this trial?

Researchers are excited about the digital therapy for postpartum depression because it uses a new method of delivering cognitive-behavioral therapy online, making it more accessible for new mothers. Unlike traditional face-to-face therapies, this digital approach allows participants to engage with the content through illustrated videos and downloadable materials at their own pace. Additionally, the option for coaching sessions via video conferences provides personalized support without the need for in-person visits. This method could make therapy more flexible and less time-consuming, which is crucial for mothers dealing with the demands of a newborn.

What evidence suggests that this digital therapy could be effective for postpartum depression?

Research has shown that digital cognitive behavioral therapy (CBT) offers a promising approach to treating postpartum depression (PND). Studies have found that online CBT effectively reduces PND symptoms, providing results comparable to traditional in-person therapy. For instance, one CBT app significantly improved mood and reduced depression in new mothers. In this trial, participants in the "Tier 2 - PND Digital Therapy with Coaching" arm will access a perinatal depression online CBT course, allowing new mothers to receive therapy at home, which suits their busy schedules. Additionally, data from devices like phones and watches may help predict treatment response, potentially leading to better outcomes.26789

Who Is on the Research Team?

NF

Nelson Freimer, MD

Principal Investigator

University of California, Los Angeles

MG

Michelle G Craske, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for women in their last trimester of pregnancy or who have recently given birth and are experiencing symptoms of depression. The study especially aims to include low-income mothers who may not have had much access to mental health care.

Inclusion Criteria

I am 18 years old or older.
Able to read and communicate in English
Between 28 weeks pregnant and 12 weeks postpartum
See 5 more

Exclusion Criteria

Severe uncontrolled medical conditions (e.g., anorexia nervosa, cardiac conditions requiring continuous monitoring)
I have been diagnosed with psychosis not caused by depression.
Cognitive impairment (e.g., developmental disability, dementia)
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Digital Sensing

Collection of digital sensing data from phones and watches during the first four weeks of study participation

4 weeks
Data collection via digital devices

Treatment

Participants receive STAND for PND treatment, including digital CBT for moderate symptoms or clinician-delivered CBT with pharmacotherapy for severe symptoms

12 weeks
Weekly sessions via secure video conference

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Digital Sensing Data Collection

Trial Overview

The study is testing if using data from phones and watches, along with regular symptom check-ins, can better predict how well digital or clinician-guided therapy works for perinatal depression over a 12-week period.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Tier 2 - PND Digital Therapy with CoachingActive Control1 Intervention
Group II: Tier 3 - Clinical CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Foundation for Women's Health

Collaborator

Citations

National Helpline for Mental Health, Drug, Alcohol Issues

SAMHSA's National Helpline is a free, confidential, 24/7, 365-day-a-year treatment referral and information service (in English and Spanish) ...

The Effects of Online Cognitive Behavioral Therapy on ... - PMC

Background/Objectives: Postpartum depression seriously affects the safety and health of mothers and children. Online cognitive behavioral therapy is ...

Is Electronically-Delivered Cognitive Therapy Effective in ...

Is Electronically-Delivered Cognitive Therapy. Effective in Producing Remission from Clinical. Depression in Postpartum Women by 15 Weeks. After ...

Effectiveness of an app-based cognitive behavioral therapy ...

The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression.

Digital Cognitive Behavioral Therapy for Depression ...

This review suggests that CBT can be used to target depression during pregnancy and can be delivered using a digital platform.

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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.

Internet Cognitive Behavioral Therapy for Women With ...

Background: There are few published controlled trials examining the efficacy of Internet-based treatment for postnatal depression (PND) and ...

FDA Clears Digital Therapeutic for the Treatment of ...

MamaLift Plus is a prescription-only digital therapeutic intervention for the treatment of mild to moderate postpartum depression using several different ...

Feasibility of a Mobile App–Based Cognitive-Behavioral ...

Although numerous mental health apps exist, there is little research on developing programs to address the unique needs of perinatal individuals ...