NCT03200028

Brief Summary

The primary objective of this study is to evaluate the feasibility of the revised brain training program with individuals diagnosed with Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

June 21, 2017

Last Update Submit

October 10, 2019

Conditions

Alcohol Use DisorderPost Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

  • Acceptability

    Acceptability will be evaluated through Cognitive Training Acceptability Measure. This measure is comprised of 17 statements about their training experience and participants will be asked to rate each statement on a 7-point Likert scale from Strongly Disagree to Strongly Agree.

    At 6 weeks

  • Usability

    Usability will be evaluated through the Computer System Usability Questionnaire and System Usability Scale. The Computer System Usability Questionnaire and System Usability Scale is comprised of a total of 29 statements and participants will be asked to rate the usability of the system on a 7-point Likert scale from Strongly Disagree to Strongly Agree.

    At 6 weeks

Study Arms (1)

Experimental Treatment

EXPERIMENTAL

Computerized plasticity-based adaptive cognitive training requiring a total maximum of 30 treatment sessions, up to 5 sessions per week, 30 minutes per session.

Other: Computerized Plasticity-Based Adaptive Cognitive Training

Interventions

Computerized Plasticity-Based Adaptive Cognitive TrainingOTHER

Thirty minutes of training on computerized exercises that targets executive function, memory and attention.

Experimental Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is a Veteran and is enrolled in outpatient Substance Use Disorder treatment within Veteran Affairs Palo Alto Health Care System
  • Participant meets Diagnostic and Statistical Manual of Mental Disorders-5 criteria for current Alcohol Use Disorder and seeking treatment for Alcohol Use Disorder
  • Participant meets Meet Diagnostic and Statistical Manual of Mental Disorders-5 criteria for current PTSD
  • Participant must be willing to perform daily home-based computer exercises for 6 weeks
  • Participant must demonstrate mild cognitive deficit on neuropsychological tests at the screening visit
  • Participant must be a fluent English speaker from the age of 12
  • Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a iPad screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a touchpad

You may not qualify if:

  • Participant with diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis, Traumatic Brain Injury, mental retardation or pervasive developmental disorder, epilepsy, Parkinson's Disease, delirium or dementia)
  • Participant with active suicidal ideations as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
  • Participant with problems performing assessments or comprehending or following spoken instructions
  • Participant who has been treated within 5 years of the date of consent with a computer-based cognitive training program manufactured by Posit Science
  • Participant with current severe traumatic brain injury
  • Participant with any type of dementia
  • Participant with any type of mental retardation
  • Participant with limited ability to speak/read/write/understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veterans Affairs Palo Alto Health Care System

Palo Alto, California, 94025, United States

Location

MeSH Terms

Conditions

AlcoholismStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Hyun Kyu Lee, 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

June 21, 2017

First Posted

June 27, 2017

Study Start

April 1, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

October 15, 2019

Record last verified: 2019-10

Locations

US(1)