CCTAP: Cognitive Control Training for Treatment of AUD-PTSD

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).

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder; Alcohol Use Disorder
• Intervention / Treatment: Other: Computerized Plasticity-Based Adaptive Cognitive Training

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94025
      • Veterans Affairs Palo Alto Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Treatment; 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; Thirty minutes of training on computerized exercises that targets executive function, memory and attention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Posit Science Corporation
• Collaborators: VA Palo Alto Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: June 21, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Alcohol-Related Disorders; Substance-Related Disorders; Trauma and Stressor Related Disorders; Alcoholism; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: PSC-0613-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No