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

NCT02948036 | Completed

• 2 other identifiers: PSC-1011-161R43MH111325
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  At 2 weeks, 4 weeks, 6 weeks and at 12 weeks

Secondary Outcomes (4)

• 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

Study Arms (1)

MMT

EXPERIMENTAL

Mobile-device, plasticity-based adaptive cognitive treatment

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

Interventions

Mobile-device, plasticity-based adaptive cognitive treatment OTHER

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).

Also known as: MMT

MMT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participant must be 18 to 60 years of age.
• Participant must score ≥ 9 on the Patient Health Questionnaire-9 (PHQ-9).
• Participant taking antidepressants or engaged in psychotherapy will not be excluded. If potential participants are currently prescribed psychotropic medication, they must be on a clinically stable medication regimen for ≥ 6 weeks prior to screening, based on self-report or as verified by medical health records, when available and authorized.
• Participant must be a fluent English speaker.
• 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.
• Participant must have access to wireless Internet connectivity.
• Participant must be willing to communicate with study staff via email.

You may not qualify if:

• Participant with unstable and/or untreated conditions that may affect cognition, including untreated substance abuse/dependence disorders, unmanaged cardiovascular disease, endocrine or neurologic disorder, epilepsy, brain injury, hospitalization within 6-weeks of enrollment, ongoing chemotherapy or other cancer treatment (e.g., radiation) .
• Participant with history or current DSM-5 diagnosis of psychosis, such as 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.
• Participant has a history or current diagnosis of dementia and/or scores less than a 14 (75%) on the UBACC.
• Participant with active suicidal ideations or behaviors within 2 months of screening.
• 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.
• 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, are likely to present significant problems for the staff conducting assessments.
• 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..
• Participant is using computer-based cognitive training programs or has used it within a month of the consent date.

Sponsors & Collaborators

• Posit Science Corporation: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Minnesota: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

2-methylcyclopentadienyl manganese tricarbonyl

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Gamze Balci, MD

  University of Minnesota - Department of Psychiatry

  PRINCIPAL INVESTIGATOR

• Thomas Van Vleet, PhD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: October 28, 2016
• Study Start: October 1, 2017
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Locations

US (1)