MedTrace Logo

Curio Digital Therapy for the Treatment of Post-partum Depression

NCT05958095 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2023-07-24

No results posted yet for this study

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

Interventions

DEVICE

MamaLift Plus

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.

DEVICE

Digital Sham App

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

Sponsors & Collaborators

  • Curio Digital Therapeutics, Inc.

    collaborator INDUSTRY

  • Healthcare Innovation Technology Lab

    lead INDUSTRY

Principal Investigators

  • Stan Kachnowski, PhD · Healthcare Innovation Technology Lab

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2023-05-24
Completion
2023-08-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05958095 on ClinicalTrials.gov