CCTAP: Cognitive Control Training for Treatment of AUD-PTSD

Alcohol Use Disorder Clinical Trial

Official title:

CCTAP: Cognitive Control Training for Treatment of AUD-PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03200028
• Other study ID #: PSC-0613-17
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: October 2019
• Source: Posit Science Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Disease
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Computerized Plasticity-Based Adaptive Cognitive Training
Thirty minutes of training on computerized exercises that targets executive function, memory and attention.

Locations

Country	Name	City	State
United States	Veterans Affairs Palo Alto Health Care System	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Posit Science Corporation	VA Palo Alto Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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