(517 days)
Not Found
No
The description focuses on delivering standard CBT principles via software and personalized guidance based on user input, without mentioning AI or ML algorithms for analysis or decision-making.
Yes
The device is intended to treat mild to moderate postpartum depression by improving a patient's symptoms of depression, which is a therapeutic purpose.
No
The device is a therapeutic digital health application intended to treat symptoms of postpartum depression, not diagnose it. While it tracks patient-reported data, this is for monitoring progress in treatment, not for making an initial diagnosis.
Yes
The device description explicitly states that MamaLift Plus is a "digital therapy designed to treat symptoms of postpartum depression by delivering evidence-based therapeutic components of Cognitive Behavioral Therapy (CBT) via software on a mobile application (smartphone or tablet)." It details the software features and the clinician dashboard, with no mention of any accompanying hardware components being part of the medical device itself.
Based on the provided information, MamaLift Plus is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used to diagnose, monitor, or screen for diseases or conditions.
- MamaLift Plus Function: MamaLift Plus is a digital therapeutic that delivers cognitive behavioral therapy (CBT) interventions through a mobile application. It treats postpartum depression by providing therapeutic content and tools to the patient directly. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it provides "neurobehavioral interventions" and "treats mild to moderate postpartum depression by improving a patient's symptoms of depression." This is a therapeutic intervention, not a diagnostic test.
- Device Description: The description focuses on the software delivering therapeutic content, tracking patient-reported data (mood, sleep, activity), and providing a clinician dashboard for monitoring. There is no mention of analyzing biological samples.
Therefore, MamaLift Plus falls under the category of a digital therapeutic or software as a medical device (SaMD) that provides behavioral health treatment, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
MamaLift Plus is a prescription-only digital therapeutic intended to provide neurobehavioral interventions to patients 22 years of age and older, as an adjunct to clinician-managed outpatient care. MamaLift Plus treats mild to moderate postpartum depression by improving a patient's symptoms of depression.
Product codes
SAP
Device Description
MamaLift Plus is a digital therapy designed to treat symptoms of postpartum depression by delivering evidence-based therapeutic components of Cognitive Behavioral Therapy (CBT) via software on a mobile application (smartphone or tablet). MamaLift Plus is indicated as a behavioral health intervention for patients 22 years of age and older with mild to moderate symptoms of depression by improving their symptoms of depression. As with face- to-face CBT, MamaLift Plus uses personalized cognitive restructuring as the main therapeutic component to improve the symptoms of postpartum depression. This element is mapped onto standard, evidence-based CBT interventions that are developed for and provided by a therapist in a face-toface care setting with a patient. The content is conveyed via a sequence of eight self-guided and interactive treatment modules daily over a period of eight to nine weeks sequentially.
Patients are encouraged to complete all eight modules of the MamaLift Plus application at the rate of one module per week. However, the entire program can last up to 9 weeks, inclusive of the baseline and posttreatment assessment periods. Full engagement by prescribing clinicians and their support staff facilitates effective use by patients of the prescribed treatment and their continued use in conjunction with ongoing monitoring by the clinician.
The content of MamaLift Plus is delivered through a variety of features which include text, personalized goal setting, graphical feedback based on inputted symptoms, and illustrations to enrich comprehension, quizzes to test and enhance user knowledge, video vignettes to promote user identification with material, and video-based expert explanations. Periodic notifications or "nudges" are also sent to increase user engagement and encourage program adherence. Additional features of MamaLift Plus include a daily tracker in which patients can self- monitor and record standardized sleep parameters (e.g., sleep and naps), self-reports of perceived Sleep Quality, and self-reports of perceived Energy Level. In addition, MamaLift Plus offers a daily mood tracker and activity tracker. The application provides personalized cognitive restructuring guidance based on the individual's beliefs, context, and attitudes.
To facilitate its use as an adjunct to outpatient standard of care conducted under the supervision of a qualified health care provider, MamaLift Plus includes a clinician facing dashboard summarizes patient use of the mobile application during the treatment period thereby enabling the clinician to assess and monitor their patient's progress throughout the therapeutic period. Clinical data collected via the patient interface, including self-reports of depressive symptoms/moods, and sleep data, are also displayed via the clinician dashboard. (All data are encrypted and compliant with data privacy and patient confidentiality requirements of the Health Insurance Portability Act.) These features are intended to support the clinician and enable patient follow up, engagement and communication of healthcare decisions. This facilitates treatment adherence and achievement of optimal patient outcomes. These are critical components that demonstrate the effectiveness of MamaLift Plus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
22 years of age and older
Intended User / Care Setting
Adjunct to clinician-managed outpatient care. Health care settings or home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
US Pivotal Study Design: The indication for use is supported by the results from the SuMMER (Supporting Maternal health & Emotional Regulation), a pivotal, remote, sham controlled, randomized study that enrolled 141 participants in the 33 states of USA: 4 states with the largest enrolments are California, New York, Florida, and Texas. The patients were recruited using online-ads (Google Ads, Reddit Ads) and social media (Instagram Ads).
The participants were randomized in a 2:1 ratio to the treatment arm (CDT001, MamaLift Plus plus treatment as usual (TAU)) or sham control arm (CDP002, Digital Placebo arm plus TAU). The study was powered to enroll 210 US subjects in total (140 in CDT001 and 70 in CDT002). The protocol allowed for an interim analysis to meet the cutoff date for an FDA response. A total of 141 subjects were enrolled when the study was stopped for this purpose. Sponsor chose a 2:1 ratio for the following reasons: increased exposure to active arm, more data in active arm, and to facilitate recruitment and retention. The study sample size was planned to have 80% power for the primary endpoint for a 2:1 randomization was stratified by "New Mother" status (Yes/No).
Assessments were scheduled for week 8 (end of study). There was no planned follow-up after the week 8 assessment.
US Pivotal Study Population: The study enrolled female patients from 18 to 50 years who gave birth within 3 months prior to the enrollment, had an EPDS score at baseline between 13-19 (inclusive) and a confirmatory clinical diagnosis of PPD that was confirmed by licensed behavioral health therapist or medical professional.
Only those participants were included who answered "0/Never" or "1/Hardly Ever" to the self-harm question (question number 10) on the EPDS questionnaire.
Key exclusion criteria included patients who were diagnosed with serious mental illness (SMIS) as defined by psychotic symptoms or treatment-resistant depression (which includes participants hospitalized for depression or currently using more than 2 medications for depression at the same time); or cognitive impairment.
Participants were randomly assigned to one of two arms: treatment as usual (TAU) or sham control plus TAU. Participants were allowed to continue with TAU in both arms. The sham control mimicked the features, functionality, and user experience of the treatment. It was designed to appear and feel similar to the treatment, but without the therapeutic or active ingredients that would induce the intended physiological or psychological effects. Specifically, the most important difference between participants in the two arms was that participants in sham control app did not receive any CBT content. Sham control content paralleled the treatment arm with regards to frequency of engaging with the app and the relative "workload" in each arm was similar.
Analysis Populations:
Intent to Treat (ITT): 95 for MamaLift Plus (CDT001), 46 for Sham Control (CDP002).
Full Analysis Set (FAS): 90 for MamaLift Plus (CDT001), 40 for Sham Control (CDP002).
Evaluable Set (EP): 78 for MamaLift Plus (CDT001), 38 for Sham Control (CDP002).
Effectiveness Endpoints:
Primary Endpoint: "4 or more points improvement in the Edinburgh Postpartum Depression Scale (EPDS)."
Key Secondary Endpoint: Improvement of EPDS below the threshold (
§ 882.5801 Computerized behavioral therapy device for psychiatric disorders.
(a)
Identification. A computerized behavioral therapy device for psychiatric disorders is a prescription only device intended to provide a computerized version of condition-specific behavioral therapy as an adjunct to clinician supervised outpatient treatment to patients with psychiatric conditions. The digital therapy is intended to provide patients access to therapy tools used during treatment sessions to improve recognized treatment outcomes.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must be provided to fulfill the following:
(i) Describe a validated model of behavioral therapy for the psychiatric disorder; and
(ii) Validate the model of behavioral therapy as implemented by the device.
(2) Software must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis must be performed. Software documentation must demonstrate that the device effectively implements the behavioral therapy model.
(3) The following labeling must be provided:
(i) Patient and physician labeling must include instructions for use, including images that demonstrate how to interact with the device.
(ii) Patient and physician labeling must list compatible devices.
(iii) Patient and physician labeling must include a warning that the device is not intended for use as a standalone therapy.
(iv) Patient and physician labeling must include a warning that the device does not represent a substitution for the patient's medication.
(v) Physician labeling must include a summary of the clinical testing with the device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 22, 2024
Curio Digital Therapeutics Inc. Shailja Dixit CEO 100 Outlook Drive. 2nd Floor Princeton, New Jersey 08540-7814
Re: K223515
Trade/Device Name: MamaLift Plus Regulation Number: 21 CFR 882.5801 Regulation Name: Computerized behavioral therapy device for psychiatric disorders Regulatory Class: Class II Product Code: SAP Dated: February 14, 2024 Received: February 14, 2024
Dear Shailja Dixit:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Kang -S
for Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K223515
Device Name MamaLift Plus
Indications for Use (Describe)
MamaLift Plus is a prescription-only digital therapeutic intended to provide neurobehavioral interventions to patients 22 years of age and older, as an adjunct to clinician-managed outpatient care. MamaLift Plus treats mild to moderate postpartum depression by improving a patient's symptoms of depression.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
MamaLift Plus Submission Number: K223515
Submitter:
Curio Digital Therapeutics, Inc. 100 Overlook Drive, Floor 2 Princeton, NJ 08540-7814 Phone: 267-629-9674 Contact person: Shailja Dixit
Date Prepared: April 18, 2024
Name of Device: MamaLift Plus™ Common or Usual Name: Prescription Digital Therapeutic for Postpartum Depression Regulation Number: 21 CFR 882.5801 Regulation Name: Computerized Behavioral Therapy Device for Psychiatric Disorders Product Code: SAP Product Code Name: Computerized behavioral therapy device for depressive disorders. Regulatory Class: II
Predicate Device: Somryst™ (K191716) by Pear Therapeutics Inc., a cognitive behavioral therapy for insomnia (CBT-I) via a mobile application). Trade/Device Name: Somryst Regulation Number: 21 CFR 882.5801 Regulation Name: Computerized Behavioral Therapy Device for Psychiatric Disorders Product Code: QVO Product Code Name: Computerized behavioral therapy device for insomnia Regulatory Class: Class II
Device Description:
MamaLift Plus is a digital therapy designed to treat symptoms of postpartum depression by delivering evidence-based therapeutic components of Cognitive Behavioral Therapy (CBT) via software on a mobile application (smartphone or tablet). MamaLift Plus is indicated as a behavioral health intervention for patients 22 years of age and older with mild to moderate symptoms of depression by improving their symptoms of depression. As with face- to-face CBT, MamaLift Plus uses personalized cognitive restructuring as the main therapeutic component to improve the symptoms of postpartum depression. This element is mapped onto standard, evidence-based CBT interventions that are developed for and provided by a therapist in a face-toface care setting with a patient. The content is conveyed via a sequence of eight self-guided and interactive treatment modules daily over a period of eight to nine weeks sequentially.
Patients are encouraged to complete all eight modules of the MamaLift Plus application at the rate of one module per week. However, the entire program can last up to 9 weeks, inclusive of the baseline and posttreatment assessment periods. Full engagement by prescribing clinicians and their support staff facilitates effective use by patients of the prescribed treatment and their continued use in conjunction with ongoing monitoring by the clinician.
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The content of MamaLift Plus is delivered through a variety of features which include text, personalized goal setting, graphical feedback based on inputted symptoms, and illustrations to enrich comprehension, quizzes to test and enhance user knowledge, video vignettes to promote user identification with material, and video-based expert explanations. Periodic notifications or "nudges" are also sent to increase user engagement and encourage program adherence. Additional features of MamaLift Plus include a daily tracker in which patients can self- monitor and record standardized sleep parameters (e.g., sleep and naps), self-reports of perceived Sleep Quality, and self-reports of perceived Energy Level. In addition, MamaLift Plus offers a daily mood tracker and activity tracker. The application provides personalized cognitive restructuring guidance based on the individual's beliefs, context, and attitudes.
To facilitate its use as an adjunct to outpatient standard of care conducted under the supervision of a qualified health care provider, MamaLift Plus includes a clinician facing dashboard summarizes patient use of the mobile application during the treatment period thereby enabling the clinician to assess and monitor their patient's progress throughout the therapeutic period. Clinical data collected via the patient interface, including self-reports of depressive symptoms/moods, and sleep data, are also displayed via the clinician dashboard. (All data are encrypted and compliant with data privacy and patient confidentiality requirements of the Health Insurance Portability Act.) These features are intended to support the clinician and enable patient follow up, engagement and communication of healthcare decisions. This facilitates treatment adherence and achievement of optimal patient outcomes. These are critical components that demonstrate the effectiveness of MamaLift Plus.
Indications for use:
MamaLift Plus™ is a prescription-only digital therapeutic intended to provide neurobehavioral interventions to patients 22 years of age and older, as an adjunct to clinician-managed outpatient care. MamaLift Plus treats mild to moderate postpartum depression by improving a patient's symptoms of depression.
Substantial Equivalence Comparison:
The table below compares the intended use and technological characteristics of MamaLift Plus and the predicate device.
| Item | Subject Device
MamaLift Plus | Proposed Predicate
Device (K191716)
Somryst | Comparison |
|------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------|
| Medical Device
Type | Software as a Medical
Device (SaMD) | Software as a Medical
Device (SaMD) | Same |
| Product Code
Name | Computerized behavioral
therapy device for
depressive disorders. | Computerized behavioral
therapy device for insomnia | Similar, therapies for
different conditions |
| Regulation
Number | 21 CFR 882.5801 | 21 CFR 882.5801 | Same |
| Regulation
Name | Computerized Behavioral
Therapy Device for
Psychiatric Disorders | Computerized
behavioral therapy
device for psychiatric
disorders | Same |
| Product Code | SAP | QVO | Similar |
Technological Characteristics Comparison
5
| Device Type | Class II | Class II | Same |
|---|---|---|---|
| Software | |||
| Architecture | Patient facing mobile | ||
| application, clinician | |||
| facing dashboard, backend | |||
| services. | Patient facing mobile | ||
| application, clinician | |||
| facing dashboard, | |||
| backend services. | Same | ||
| Mechanism of | |||
| Action | Cognitive Behavioral | ||
| Therapy (for Post | |||
| partum depression) | Cognitive Behavioral | ||
| Therapy (for Insomnia). | Similar, therapies for | ||
| different conditions only. | |||
| Software Content | Text, video, and audio | ||
| content. | Text, video, and audio | ||
| content. | Same | ||
| Therapy Duration | 8-9 weeks | 9 weeks | Similar, 0 to 1 week less |
| duration in subject device | |||
| Intended | |||
| Environments | Health care settings or | ||
| home | Health care settings or | ||
| home | Same | ||
| Target | |||
| Population | Female patients 22 years | ||
| of age and older | |||
| diagnosed with post | |||
| partum depression | |||
| currently enrolled in | |||
| outpatient treatment | |||
| under the supervision | |||
| of a clinician | Patients 22 years of age | ||
| and older who are | |||
| currently enrolled in | |||
| outpatient treatment | |||
| under the supervision of a | |||
| clinician | Similar, one is gender based | ||
| User Interface | Software application that | ||
| requires users to log in, | |||
| go through modules of | |||
| therapeutic content | |||
| (text, video, audio), | |||
| interact with the device, | |||
| and receive notifications | |||
| to increase engagement | |||
| and encourage | |||
| program adherence. | Software application that | ||
| requires users to log in, | |||
| go through modules of | |||
| therapeutic content (text, | |||
| video, audio), interact | |||
| with the device (through | |||
| quizzes, videos, reporting | |||
| sleep and mood, etc.), and | |||
| receive notifications to | |||
| increase engagement and | |||
| encourage program | |||
| adherence. | Similar, interactions | ||
| tailored for different | |||
| conditions. | |||
| Mobile Platform | Smartphones, tablets (iOS | ||
| and Android) | Smartphones, tablets (iOS | ||
| and Android) | Same |
The subject and predicate device implement similar device technologies with similar architectures and software content in the intended environments. In addition, both MamaLift Plus and Somryst are computerized behavioral therapy devices for psychiatric disorders regulated under 21 CFR 882.5801. The products deliver digitized cognitive behavioral therapy and are deployed through mobile applications for smart devices. They both have a sequence of content modules with similar behavioral treatment techniques, software architecture, and are prescription devices.
MamaLift Plus and Somryst are both intended to be used by patients 22 years of age or older, however, MamaLift Plus is solely to be used by those diagnosed with post-partum depression. The Mechanism
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of Action and User Interface are similar for both devices but tailored for different therapeutic conditions.
Non-Clinical Performance Data:
Testing to support the safety and performance of MamaLift Plus can be summarized as follows:
- . Human factors testing for functionality and usability as per recommendations of the 2016 guidance document Applying Human Factors and Usability Enqineering to Medical Devices
- . Functional and Software verifications and validation testing as per recommendations of 2019 FDA Policy for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff
- . Matrix Traceability testing as per recommendations of 2019 FDA Policy for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff
- . Cybersecurity per recommendations of FDA's April 8, 2022, draft guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions for supporting its premarket submission.
Clinical Performance Data:
Performance to assess safety and efficacy in MamaLift Plus was addressed as per the 2017 FDA Policy for Software as a Medical Device (SaMD): Clinical Evaluation Guidance for Industry and Food and Drug Administration Staff.
US Pivotal Study Design
The indication for use is supported by the results from the SuMMER (Supporting Maternal health & Emotional Regulation), a pivotal, remote, sham controlled, randomized study that enrolled 141 participants in the 33 states of USA: 4 states with the largest enrolments are California, New York, Florida, and Texas. The patients were recruited using online-ads (Google Ads, Reddit Ads) and social media (Instagram Ads).
The participants were randomized in a 2:1 ratio to the treatment arm (CDT001, MamaLift Plus plus treatment as usual (TAU)) or sham control arm (CDP002, Digital Placebo arm plus TAU). The study was powered to enroll 210 US subjects in total (140 in CDT001 and 70 in CDT002). The protocol allowed for an interim analysis to meet the cutoff date for an FDA response. A total of 141 subjects were enrolled when the study was stopped for this purpose. Sponsor chose a 2:1 ratio for the following reasons: increased exposure to active arm, more data in active arm, and to facilitate recruitment and retention. The study sample size was planned to have 80% power for the primary endpoint for a 2:1 randomization was stratified by "New Mother" status (Yes/No).
Assessments were scheduled for week 8 (end of study). There was no planned follow-up after the week 8 assessment.
US Pivotal Study Population
The study enrolled female patients from 18 to 50 years who gave birth within 3 months prior to the enrollment, had an EPDS score at baseline between 13-19 (inclusive) and a confirmatory clinical diagnosis of PPD that was confirmed by licensed behavioral health therapist or medical professional.
Only those participants were included who answered "0/Never" or "1/Hardly Ever" to the self-harm question (question number 10) on the EPDS questionnaire.
Curio Digital Therapeutics Inc., 100 Overlook Center, 2nd floor, Princeton, NJ 08540
7
Key exclusion criteria included patients who were diagnosed with serious mental illness (SMIS) as defined by psychotic symptoms or treatment-resistant depression (which includes participants hospitalized for depression or currently using more than 2 medications for depression at the same time); or cognitive impairment.
Participants were randomly assigned to one of two arms: treatment as usual (TAU) or sham control plus TAU. Participants were allowed to continue with TAU in both arms. The sham control mimicked the features, functionality, and user experience of the treatment. It was designed to appear and feel similar to the treatment, but without the therapeutic or active ingredients that would induce the intended physiological or psychological effects. Specifically, the most important difference between participants in the two arms was that participants in sham control app did not receive any CBT content. Sham control content paralleled the treatment arm with regards to frequency of engaging with the app and the relative "workload" in each arm was similar.
Analysis Populations
The Intent to Treat Analysis Set (ITT) included all randomized participants who started at least 1 module. ITT participants with no post-baseline EPDS assessment were classified as non-responders.
Full Analysis Set (FAS) is a subset of the ITT and included all participants randomized in the study who started at least 1 module and provided a post-baseline (either Week 4 or end of treatment) EPDS assessment. This population was used for primary effectiveness analyses. For participants with no week 8 EPDS assessment in ITT and FAS, their week 4 EPDS value was used.
Evaluable Population (EP) population is a subset of the FAS and included all participants who completed their baseline and end of treatment EPDS assessments.
The sample sizes for the 3 analysis sets are shown in Table 2. A small number of participants (5 in treatment and 6 in sham control) did not provide any post-baseline EPDS assessment. Missing rates are 5.3% and 13.0% for the treatment and control arms, respectively.
| Analysis Set | MamaLift Plus
(CDT001) | Sham Control (CDP002) |
|-------------------------|---------------------------|-----------------------|
| Intent to Treat (ITT) | 95 | 46 |
| Full Analysis Set (FAS) | 90 | 40 |
| Evaluable Set (EP) | 78 | 38 |
Table 2: Participant Disposition
Socio-demographic baseline characteristics of the ITT population are presented in Table 3. The two groups are comparable in age (32.39 vs 30.74 years), marital status (76.8% vs 82.6% married/living together) and educational level (68.4% vs 80% higher education). Approximately two-thirds (63.1% vs 67.3%) of the women were first time mothers in each of the study arms.
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Table 3: Socio-demographic characteristics (ITT)
| | MamaLift Plus
(CDT001) | Sham Control
(CDP002) |
|-------------------------|---------------------------|--------------------------|
| | N= 95 | N=46 |
| Age | 32.39 (5.54) | 30.74 (5.54) |
| Marital status | | |
| Married/living together | 73 (76.8%) | 38 (82.6%) |
| Educational level | | |
| Until High school | 25 (26.3%) | 7 (15.2%) |
| Higher education | 65 (68.4%) | 36 (80.0%) |
| Other or Unknown | 5 (5.3%) | 3 (4.8%) |
| New Mom | | |
| Yes | 60 (63.1%) | 31 (67.3%) |
| Region (USA) | | |
| California | 12 (12.6%) | 8 (17.4%) |
| New York | 10 (10.5%) | 6 (13%) |
| Texas | 12 (12.6%) | 3 (6.5%) |
| Florida | 7 (7.4%) | 2 (4.3%) |
| All other States | 54 (56.8%) | 27 (58.7%) |
Effectiveness Endpoints
Primary Endpoint: The primary end point of the study was "4 or more points improvement in the Edinburgh Postpartum Depression Scale (EPDS)." The 4-point improvement is considered a clinically meaningful improvement.
Key Secondary Endpoint: Improvement of EPDS below the threshold (