Search Results

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.

Here's an analysis based on your requested information:

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.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size:
  • Total Enrolled: 141 participants
  • Intent to Treat (ITT) Analysis Set: MamaLift Plus: 95; Sham Control: 46
  • Full Analysis Set (FAS): MamaLift Plus: 90; Sham Control: 40
  • Evaluable Population (EP): MamaLift Plus: 78; Sham Control: 38
• Data Provenance: The study was a "pivotal, remote, sham controlled, randomized study" conducted in the USA, enrolling participants from 33 states. The study utilized prospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for participant eligibility (diagnosis of PPD) was established by a "confirmatory clinical diagnosis of PPD that was confirmed by licensed behavioral health therapist or medical professional." The number of these experts involved in confirming the diagnosis for the test set is not specified.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method like 2+1 or 3+1 for the test set. The clinical diagnosis of PPD was confirmed by licensed professionals, but there's no mention of multiple experts reviewing cases or a specific method for resolving discrepancies.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This study focuses on the effectiveness of a digital therapeutic (MamaLift Plus) as an adjunct to clinician-managed outpatient care, not on improving human reader performance with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The study assessed the performance of MamaLift Plus plus Treatment as Usual (TAU) compared to Sham Control plus TAU. While MamaLift Plus is a digital therapeutic, its intended use is "as an adjunct to clinician-managed outpatient care" and "under the supervision of a clinician." Therefore, it is not a standalone algorithm-only performance study without human-in-the-loop, as ongoing monitoring and clinical oversight are part of its intended use.

7. The Type of Ground Truth Used

The ground truth for the efficacy evaluation was based on clinical assessment scores from the Edinburgh Postpartum Depression Scale (EPDS) and confirmed clinical diagnosis of PPD by licensed behavioral health therapists or medical professionals.

8. The Sample Size for the Training Set

The document does not provide information about a separate training set or its sample size. The clinical study described is a pivotal trial for effectiveness, indicating it's likely the primary method of validating the device's performance rather than a training dataset for an AI model. MamaLift Plus uses "personalized cognitive restructuring as the main therapeutic component," derived from "standard, evidence-based CBT interventions." This suggests the content is based on established therapeutic practices rather than a machine learning model trained on a specific dataset.

9. How the Ground Truth for the Training Set Was Established

Since no training set is explicitly mentioned for an AI model, the method for establishing its ground truth is not applicable based on the provided text. The therapeutic content stems from evidence-based Cognitive Behavioral Therapy (CBT) principles.

Ask a specific question about this device