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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
This study employs a mobile-device delivered treatment program. Participants will be asked to use the assigned treatment program for approximately 30 minutes per session, up to seven sessions per week, over 6 weeks (42 total sessions).
University of Minnesota
Minneapolis, Minnesota, United States
Change in total score for depressive symptoms using Beck Depression Scale (BDI-II)
The Beck Depression Scale (BDI-II) is a self-report questionnaire that assesses depressive symptoms with a scoring range between 0-63.
Time frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
Change in total score for depressive symptoms using Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ-9) is a self-report questionnaire that assesses the degree of depression severity with a scoring range between 0-27.
Time frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
Change in total score for anxiety symptoms using Generalized Anxiety Disorder (GAD-7)
The Generalized Anxiety Disorder (GAD-7) is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder with a scoring range between 0-21.
Time frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
Change in total score for mood symptoms using Immediate Mood Scaler (IMS)
The Immediate Mood Scaler (IMS) is a clinical assessment that assesses momentary mood symptoms related to anxiety and depression with a scoring range between 22-181.
Time frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
Change in total score for quality of life using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) assesses the degree of enjoyment and satisfaction experienced in various areas of daily functioning with a scoring range between 0-70.
Time frame: At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
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