Clinical trial NCT05958095: Curio Digital Therapy for the Treatment of Post-partum Depression
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: PostPartum Depression
Keywords: PostPartum depression (PPD), symptoms of PPD, Anxiety, Peri-natal depression, mild-to-moderate depression
Lead sponsor: Healthcare Innovation Technology Lab
Sponsor class: INDUSTRY
Collaborators: name: Curio Digital Therapeutics, Inc.
First posted: 2023-07-24
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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:

-

Primary outcomes:
measure: EPDS Score
timeFrame: 9 week period
measure: EPDS Score improvement
timeFrame: 9 week period
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Healthcare Innovation and Technology Lab
state: New York
Study officials:
affiliation: Healthcare Innovation Technology Lab
name: Stan Kachnowski, PhD
role: PRINCIPAL_INVESTIGATOR
References: