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

• ClinicalTrials.gov Identifier: NCT05958095
• Recruitment Status: Active, not recruiting
• First Posted: July 24, 2023
• Last Update Posted: July 24, 2023
• Sponsor: Healthcare Innovation Technology Lab
• Collaborator: Curio Digital Therapeutics, Inc.
• Information provided by (Responsible Party): Stan Kachnowski, Healthcare Innovation Technology Lab

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.

Condition or disease	Intervention/treatment	Phase
PostPartum Depression	Device: MamaLift Plus; Device: Digital Sham App	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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: Single (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.
• Primary Purpose: Treatment
• Official Title: Supporting Maternal Mental Health and Emotional Regulation (SuMMER): Assessment of the Clinical Effectiveness of a Mobile Application for Patients With Postpartum Depression
• Actual Study Start Date: April 1, 2023
• Actual Primary Completion Date: May 24, 2023
• Estimated Study Completion Date: August 15, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: MamaLift Plus; Principles of Cognitive Behavioral Therapy used to treat PPD with App	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.
Sham Comparator: Digital Sham App; Content on general mental health and wellbeing topics delivered with sham App	Device: Digital Sham App; The digital sham app delivers content, tips, and suggestion for general wellbeing support.

Outcome Measures

Primary Outcome Measures :

1. EPDS Score [ Time Frame: 9 week period ]
   Proportion of women that improve EPDS by >= 4 points at their end of study assessment.
2. EPDS Score improvement [ Time Frame: 9 week period ]
   Proportion of women that improve EPDS to < 13 points at their end of study assessment

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Adult females who delivered live births in the 3 months prior to study start
• Accepts Healthy Volunteers: Yes

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:

-

Contacts and Locations

Locations

United States, New York

Healthcare Innovation and Technology Lab

New York, New York, United States, 10032

Sponsors and Collaborators

Healthcare Innovation Technology Lab

Curio Digital Therapeutics, Inc.

Investigators

• Principal Investigator: Stan Kachnowski, PhD; Healthcare Innovation Technology Lab

More Information

• Responsible Party: Stan Kachnowski, Chair, Healthcare Innovation Technology Lab
• ClinicalTrials.gov Identifier: NCT05958095
• Other Study ID Numbers: CU-T-003
• First Posted: July 24, 2023
• Last Update Posted: July 24, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Stan Kachnowski, Healthcare Innovation Technology Lab:

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

Additional relevant MeSH terms:

Depression, Postpartum; Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases