Curio Digital Therapy for the Treatment of Post-partum Depression

NCT05958095 | Unknown FDA Device

• 1 other identifier: CU-T-003
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: Evaluate the clinical effectiveness of the MamaLift Plus app compared to control (digital sham plus treatment as usual) for the management of PPD in the observed population for a period of 9 calendar weeks. It is hypothesized that women who use the MamaLift Plus APP will experience less severe symptoms of depression in post-partum period than comparable women who do not and receive their usual care from health providers.

Conditions

PostPartum Depression

Keywords

PostPartum depression (PPD), symptoms of PPD, Anxiety, Peri-natal depression, mild-to-moderate depression

Outcome Measures

Primary Outcomes (2)

• EPDS Score

  Proportion of women that improve EPDS by \>= 4 points at their end of study assessment.

  9 week period

• EPDS Score improvement

  Proportion of women that improve EPDS to \< 13 points at their end of study assessment

  9 week period

Study Arms (2)

MamaLift Plus

EXPERIMENTAL

Principles of Cognitive Behavioral Therapy used to treat PPD with App

Device: MamaLift Plus

Digital Sham App

SHAM COMPARATOR

Content on general mental health and wellbeing topics delivered with sham App

Device: Digital Sham App

Interventions

MamaLift Plus DEVICE

MamaLift Plus is a digital therapeutic designed to augment usual care and support the treatment of mild-to-moderate postpartum depression (PPD). This mobile-based intervention is grounded on principles of Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT) and includes key content areas for the treatment management of PPD. It also includes recent developments in acceptance and commitment-based therapies, specifically for the perinatal context.

MamaLift Plus

Digital Sham App DEVICE

The digital sham app delivers content, tips, and suggestion for general wellbeing support.

Digital Sham App

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Adult females who delivered live births in the 3 months prior to study start
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be able to read, write and speak English; 3. Participants must provide written informed consent prior to enrollment; 4. Participants must be 18 to 50 years of age at the time of enrollment; 5. Participants must have had a live childbirth \<=3 months prior to their enrollment into the study; 6. Participants who have a score of greater than or equal to 13 but not exceeding 19 on the Edinburgh Postnatal Depression Scale (EPDS) during initial screening visit/call; 7. Depression diagnosis needs to be confirmed by licensed behavioral health therapist or medical professional; 8. Participants must answer "0/Never" or "1/Hardly Ever" to the self-harm question on EPDS (Question #10); 9. Participants must be willing to use a mobile app and own an iOS or android enabled mobile phone or device; 10. Participants must have wireless internet connectivity in their home (or have access to internet connectivity) and be willing to connect devices via a Wi-Fi network

Sponsors & Collaborators

• Healthcare Innovation Technology Lab: lead
• Curio Digital Therapeutics, Inc.: collaborator

Study Sites (1)

Healthcare Innovation and Technology Lab

New York, New York, 10032, United States

Location

Related Publications (1)

• Dixit S, Malladi I, Shankar S, Shah A. Evaluating the Efficacy of MamaLift Plus Digital Therapeutic Mobile App for Postpartum Depression (SuMMER): Randomized, Placebo-Controlled Pivotal Trial. J Med Internet Res. 2025 Jul 1;27:e69050. doi: 10.2196/69050.

  PMID: 40549508 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Anxiety Disorders

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Stan Kachnowski, PhD

  Healthcare Innovation Technology Lab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not aware of whether they are receiving the MamaLift Plus interventional device or the digital placebo device. The applications have the same user interface and require a similar amount of time to complete activities. Participants in both arms will receive treatment as usual in addition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair

Model Details: The data of 200 participants will be collected and analyzed for this study. Participants will be selected from a pool of patients who have given birth in the last three months prior to the study start date and been diagnosed with postpartum depression or have experienced depressive symptoms. The study aims to recruit a diverse study cohort across age, race, and SES to reflect the intended user population in the United States.

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: April 1, 2023
• Primary Completion: May 24, 2023
• Study Completion: August 15, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)