Back to resultsCCTAP: Cognitive Control Training for Treatment of AUD-PTSD
Primary Purpose
Alcohol Use Disorder, Post Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Plasticity-Based Adaptive Cognitive Training
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
Eligibility 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
Sites / Locations
- Veterans Affairs Palo Alto Health Care System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental Treatment
Arm Description
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 30 treatment sessions, up to 5 sessions per week, 30 minutes per session.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03200028
First Posted
June 21, 2017
Last Updated
October 10, 2019
Sponsor
Posit Science Corporation
Collaborators
VA Palo Alto Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT03200028
Brief Title
CCTAP: Cognitive Control Training for Treatment of AUD-PTSD
Official Title
CCTAP: Cognitive Control Training for Treatment of AUD-PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Posit Science Corporation
Collaborators
VA Palo Alto Health Care System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Post Traumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Treatment
Arm Type
Experimental
Arm Description
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 30 treatment sessions, up to 5 sessions per week, 30 minutes per session.
Intervention Type
Other
Intervention Name(s)
Computerized Plasticity-Based Adaptive Cognitive Training
Intervention Description
Thirty minutes of training on computerized exercises that targets executive function, memory and attention.
Primary Outcome Measure Information:
Title
Acceptability
Description
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.
Time Frame
At 6 weeks
Title
Usability
Description
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.
Time Frame
At 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Kyu Lee, PhD
Organizational Affiliation
Posit Science Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94025
Country
United States
12. IPD Sharing Statement
Learn more about this trial
CCTAP: Cognitive Control Training for Treatment of AUD-PTSD
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