CCTAP: Cognitive Control Training for Treatment of AUD-PTSD

Study Overview
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Brief Summary
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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).

Official Title
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CCTAP: Cognitive Control Training for Treatment of AUD-PTSD

Conditions
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Alcohol Use Disorder, Post Traumatic Stress Disorder

Intervention / Treatment
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* Other: Computerized Plasticity-Based Adaptive Cognitive Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Treatment<br>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<br>* Thirty minutes of training on computerized exercises that targets executive function, memory and attention.<br>|

What is the study measuring?
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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 |