Curio Digital Therapy for the Treatment of Post-partum Depression

Healthcare Innovation Technology Lab142 enrolled

Overview

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.

Women between 18 and 50 years of age who have had a live birth within 3 months prior to study start date and have a diagnosis of mild to moderate PPD. A total of 200 women will be recruited to volunteer in the study with 166 assigned to the intervention arm and 37 assigned to the control group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

142

Conditions

PostPartum Depression

Interventions

MamaLift PlusDEVICE

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.

Digital Sham AppDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: \-

Locations (1)

Healthcare Innovation and Technology Lab

New York, New York, United States

Outcomes

Primary Outcomes

EPDS Score

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

Time frame: 9 week period

EPDS Score improvement

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

Time frame: 9 week period

Data from ClinicalTrials.gov

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