A Closed-loop Assessment and Treatment Platform for Mood Disorders

A Closed-loop Assessment and Treatment Platform for Mood Disorders

Sponsors

Lead sponsor: Posit Science Corporation

Collaborator: National Institute of Mental Health (NIMH)
University of Minnesota

Source Posit Science Corporation
Brief 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.

Detailed 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 30 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.

Overall Status Active, not recruiting
Start Date October 1, 2017
Completion Date March 30, 2020
Primary Completion Date March 30, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in total score for depressive symptoms using Beck Depression Scale (BDI-II) At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
Secondary Outcome
Measure Time Frame
Change in total score for depressive symptoms using Patient Health Questionnaire (PHQ-9) At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
Change in total score for anxiety symptoms using Generalized Anxiety Disorder (GAD-7) At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
Change in total score for mood symptoms using Immediate Mood Scaler (IMS) 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) At 2 weeks, 4 weeks, 6 weeks and at 12 weeks
Change in total score for executive function using the Multiple Object Tracking task At 6 weeks
Change in total score for inhibition using Gradual Onset Continuous Performance task At 6 weeks
Change in total score in set-shifting using Rule Switcher task At 6 weeks
Change in total score in processing speed using Visual Time Order Judgement task. At 6 weeks
Change in total score in learning using the Reinforcement Learning Task At 6 weeks and 12 weeks
Enrollment 30
Condition
Intervention

Intervention type: Other

Intervention name: Mobile-device, plasticity-based adaptive cognitive treatment

Description: 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).

Arm group label: MMT

Other name: MMT

Eligibility

Criteria:

Inclusion Criteria:

1. Participants must be 18 to 60 years of age.

2. Participant must be referred by a clinician and is currently in treatment for depression and/or anxiety, as verified by the attending clinician. Other comorbid psychiatric conditions will be verified by the attending clinician.

3. Participants taking antidepressants or engaged in psychotherapy will not be excluded; instead, their antidepressant treatment will be evaluated and entered as covariates in all statistical analyses. However, participants on antidepressants, anxiolytics, etc. must be on a stable medication regimen ≥ 6 weeks prior to screening.

4. Participants must be clinically stable and on out-patient status for a period of ≥ 6 weeks prior to screening.

5. Participant must be a fluent English speaker.

6. Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control and use a mobile device and/or computer as required to complete study activities.

7. Participant must have access to wireless Internet connectivity.

8. Participants must be willing to communicate with study staff via email.

Exclusion Criteria:

1. Participants with unstable and/or untreated conditions that may affect cognition, including substance abuse/dependence disorders, cardiovascular, endocrine, neurologic disorder, epilepsy, brain injury, recent hospitalization, ongoing chemotherapy or other cancer treatment

2. Per clinician report, participants with history or current DSM-5 diagnosis of organic mental disorder, schizophrenia, schizoaffective disorder, delusion disorder, psychotic disorder NOS, bipolar disorder, substance abuse (<1 year), and/or mood congruent or mood incongruent psychotic features or disorders.

3. Participant has a history or current diagnosis of dementia and/or scores within an abnormal range on the UBACC, at the time of screening.

4. Participant with active suicidal ideations or behaviors within 2 months of screening

5. Participant that shows signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit. Such participants will have that visit re-scheduled; participants with this problem occurring more than once may be excluded and dropped at the discretion of the Principal Investigators.

6. Participant has problems performing assessments or comprehending or following spoken instructions, or those with behaviors during screening or baseline visits that, in the judgment of the screening staff.

7. Participant is enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment that could affect the outcome of this study. However, participation in standard treatments (e.g., occupational therapy) or use of prescribed medications (e.g., anti-depressants) is allowable.

8. Participant is using computer-based cognitive training programs or has used it within a month of the consent date.

Gender: All

Minimum age: 18 Years

Maximum age: 60 Years

Healthy volunteers: No

Overall Official
Location
facility University of Minnesota
Location Countries

United States

Verification Date

March 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: MMT

Arm group type: Experimental

Description: Mobile-device, plasticity-based adaptive cognitive treatment

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov