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CCTAP: Cognitive Control Training for Treatment of AUD-PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200028
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
VA Palo Alto Health Care System
Information provided by (Responsible Party):
Posit Science Corporation

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).

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Post Traumatic Stress Disorder Other: Computerized Plasticity-Based Adaptive Cognitive Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CCTAP: Cognitive Control Training for Treatment of AUD-PTSD
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Acceptability [ Time Frame: At 6 weeks ]
    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.

  2. Usability [ Time Frame: At 6 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200028


Locations
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United States, California
Veterans Affairs Palo Alto Health Care System
Palo Alto, California, United States, 94025
Sponsors and Collaborators
Posit Science Corporation
VA Palo Alto Health Care System
Investigators
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Principal Investigator: Hyun Kyu Lee, PhD Posit Science Corporation
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Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT03200028    
Other Study ID Numbers: PSC-0613-17
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Alcoholism
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders