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Curio Digital Therapy for the Treatment of Post-partum Depression (SuMMER)

Primary Purpose

PostPartum Depression

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MamaLift Plus
Digital Sham App
Sponsored by
Healthcare Innovation Technology Lab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PostPartum Depression focused on measuring PostPartum depression (PPD), symptoms of PPD, Anxiety, Peri-natal depression, mild-to-moderate depression

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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: -

Sites / Locations

  • Healthcare Innovation and Technology Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

MamaLift Plus

Digital Sham App

Arm Description

Principles of Cognitive Behavioral Therapy used to treat PPD with App

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

Outcomes

Primary Outcome Measures

EPDS Score
Proportion of women that improve EPDS by >= 4 points at their end of study assessment.
EPDS Score improvement
Proportion of women that improve EPDS to < 13 points at their end of study assessment

Secondary Outcome Measures

Full Information

First Posted
July 14, 2023
Last Updated
July 14, 2023
Sponsor
Healthcare Innovation Technology Lab
Collaborators
Curio Digital Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05958095
Brief Title
Curio Digital Therapy for the Treatment of Post-partum Depression
Acronym
SuMMER
Official Title
Supporting Maternal Mental Health and Emotional Regulation (SuMMER): Assessment of the Clinical Effectiveness of a Mobile Application for Patients With Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
May 24, 2023 (Actual)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Healthcare Innovation Technology Lab
Collaborators
Curio Digital Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PostPartum Depression
Keywords
PostPartum depression (PPD), symptoms of PPD, Anxiety, Peri-natal depression, mild-to-moderate depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MamaLift Plus
Arm Type
Experimental
Arm Description
Principles of Cognitive Behavioral Therapy used to treat PPD with App
Arm Title
Digital Sham App
Arm Type
Sham Comparator
Arm Description
Content on general mental health and wellbeing topics delivered with sham App
Intervention Type
Device
Intervention Name(s)
MamaLift Plus
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Digital Sham App
Intervention Description
The digital sham app delivers content, tips, and suggestion for general wellbeing support.
Primary Outcome Measure Information:
Title
EPDS Score
Description
Proportion of women that improve EPDS by >= 4 points at their end of study assessment.
Time Frame
9 week period
Title
EPDS Score improvement
Description
Proportion of women that improve EPDS to < 13 points at their end of study assessment
Time Frame
9 week period

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Adult females who delivered live births in the 3 months prior to study start
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stan Kachnowski, PhD
Organizational Affiliation
Healthcare Innovation Technology Lab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healthcare Innovation and Technology Lab
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Curio Digital Therapy for the Treatment of Post-partum Depression

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