(517 days)
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.
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.
The provided text describes the MamaLift Plus device, its intended use, and the studies conducted to demonstrate its safety and effectiveness.
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1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for MamaLift Plus are based on improvements in the Edinburgh Postpartum Depression Scale (EPDS) scores.
| Acceptance Criteria (Endpoint) | Reported Device Performance (MamaLift Plus + TAU) in ITT Population | Reported Device Performance (Sham Control + TAU) in ITT Population | p-value |
|---|---|---|---|
| Primary Endpoint: Improvement of 4 or more points in EPDS | 86.3% | 23.9% |
§ 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.