A Closed-loop Assessment and Treatment Platform for Unipolar Depression and Anxiety

Major Depressive Disorder Clinical Trial

Official title: A Closed-loop Assessment and Treatment Platform for Unipolar Depression and Anxiety

Status Completed

Clinical Trial Summary

Specific Aim 1: Finalize development of the closed-loop strategy in the MMT application.

Specific Aim 2: Evaluate the acceptability and feasibility of the MMT application with the target population to prepare for a large-scale efficacy trial.

Clinical Trial Description

Specific Aim 1: Investigators have recently constructed a beta version of the MMT application, comprised of the multi-modal assessment modules, several treatment modules and an initial version of the closed-loop algorithm to control treatment delivery. Utilizing the extensive experience in developing mobile assessment and treatment tools at Posit Science Corporation, the investigators will employ an iterative development process incorporating feedback from users (focus groups of patients with mood disorders), clinicians and scientists (project consultants) to achieve the following development goals: (1) Finalize MMT's closed-loop algorithm to incorporate all assessment modules and expand the existing triage approach; (2) Expand cognitive behavioral therapy (CBT) functions within the app; and (3) Expand in-app bi-directional communication feature between the clinician and user. At the completion of Specific Aim 1, the investigators will have a mobile app suitable for evaluation in a feasibility trial (Specific Aim 2).

Specific Aim 2: The investigators will conduct a single arm, open label feasibility field trial with 40 participants that meet criteria for Major Depressive Disorder (MDD). Participants will be asked to engage with the experimental cognitive treatment and spend up to six weeks engaged in 15 hours of cognitive training as an adjunct to their standard clinical treatment. The experimental cognitive treatment will be deployed as dictated by the closed loop predictive algorithm, with all patient data continuously accessible for remote monitoring by the attending clinicians, research staff and Principal Investigator at University of Minnesota, and research staff and Sponsor PI at Posit Science Corporation. Participants will be re-evaluated every two weeks during treatment use, and again at the expected time of completion of training, at 6 weeks, to evaluate changes in cognitive function. Participants will then stop using their assigned program for 6 weeks, and return for a follow-up assessment to evaluate the endurance of changes in cognitive function in the absence of further program use. ;

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT02948036
• Study type: Interventional
• Source: Posit Science Corporation
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Completion date: May 11, 2023