Virtual Reality- Working Memory Retraining (VR-WMR)
|ClinicalTrials.gov Identifier: NCT03786276|
Recruitment Status : Completed
First Posted : December 26, 2018
Last Update Posted : May 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder Mild Traumatic Brain Injury||Behavioral: VR-WMR-Only Behavioral: Exercise-only Behavioral: Active VR-WMR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||We will use an 8-week, randomized cross--over design trial of active VR-WMR.|
|Masking:||None (Open Label)|
|Official Title:||Effects of Active Virtual Reality Working Memory Retraining on Heavy Drinking Veterans With Mild Traumatic Brain Injury|
|Actual Study Start Date :||February 1, 2019|
|Actual Primary Completion Date :||March 31, 2020|
|Actual Study Completion Date :||March 31, 2020|
Exercise-Only condition, 12 exercise sessions on a stationary recumbent bicycle over 4 weeks. After 4 weeks, the participants will have a 1-week washout followed by Active VR-WMR arm.
Participants will ride a stationary recumbent bicycle for up to 30 minutes during each training session.
Other Name: Recumbent bicycle
Virtual Reality Working Memory Retraining-Only condition, 12 working memory retraining sessions over 4 weeks. After 4 weeks, the participants will have a 1-week washout followed by Active VR-WMR arm.
Participants will spend up to 30 minutes in a VR-WMR environment during each training session.
Other Name: Virtual Reality-Working Memory Retraining
Experimental: Active VR-WMR
After 4 weeks in one of the first two arms, the participants will have a 1-week washout followed by the Active VR-WMR arm. Participants will complete 12 Active VR-WMR sessions on a stationary recumbent bicycle over 4 weeks.
Behavioral: Active VR-WMR
Participants will spend up to 30 minutes in a VR-WMR environment while riding a stationary, recumbent bicycle during each training session.
Other Name: Active Virtual Reality-Working Memory Retraining
- System Usability Scale [ Time Frame: 18 months ]A validated measure of technology usability will be administered at end of study to assess the usability of Active VR-WMR.The System Usability Scale (SUS) is a reliable 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree used to measure product usability. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. An SUS score above a 68 would be considered above average and anything below 68 is below average.
- The Client Satisfaction Questionnaire [ Time Frame: 18 months ]A validated measure of client satisfaction with an intervention will be administered at the end of study to evaluate satisfaction with Active VR-WMR. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction) with different descriptors for each response point. Total scores range from 8 to 32, with higher scores indicating greater satisfaction. A standard mean rating of ≥ 24 will be considered acceptable.
- Working Memory [ Time Frame: 18 months ]Change in working memory in each arm will be evaluated. Working Memory consists of well validated WAIS-IV Arithmetic and Digit Span Subscales. Working memory will be the average of the scaled scores (ss) of each subscale, with a mean (M) = 10 and a standard deviation (SD) = 3. The subtest ss range from 1 to 19.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786276
|United States, California|
|VA Medical Center San Francisco|
|San Francisco, California, United States, 94121|
|Principal Investigator:||David L Pennington, Ph.D.||University of California, San Francisco|