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OpenTrials
Completed

NCT Number: NCT03200028

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Veterans Affairs Palo Alto Health Care System

Palo Alto, California, 94025, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computerized plasticity-based adaptive cognitive training

Other

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Posit Science Corporation

Industry

Collaborators

  • VA Palo Alto Health Care System

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 27, 2017
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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