CCTAP: Cognitive Control Training for Treatment of AUD-PTSD

NCT ID: NCT03200028

Last Updated: 2019-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-02-28

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).

Conditions

Alcohol Use Disorder; Post Traumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Computerized Plasticity-Based Adaptive Cognitive Training

Intervention Type: OTHER

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

Interventions

Computerized Plasticity-Based Adaptive Cognitive Training

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Palo Alto Health Care System

FED

Sponsor Role: collaborator

Posit Science Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyun Kyu Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

Posit Science Corporation

Locations

Veterans Affairs Palo Alto Health Care System

Palo Alto, California, United States

Countries

United States

Other Identifiers

PSC-0613-17

Identifier Type: -

Identifier Source: org_study_id