Virtual Reality- Working Memory Retraining (VR-WMR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03786276|
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : September 27, 2019
|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)|
|Estimated 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|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||January 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786276
|Contact: Holly D Pothier, M.S.W.||415-221-4810 ext email@example.com|
|United States, California|
|VA Medical Center San Francisco||Recruiting|
|San Francisco, California, United States, 94121|
|Contact: David L Pennington, PhD 415-221-4810 ext 24504 firstname.lastname@example.org|
|Contact: Brooke Lasher, BA 4152214810 ext 24495 email@example.com|
|Principal Investigator: David L Pennington, PhD|
|Principal Investigator:||David L Pennington, Ph.D.||University of California, San Francisco|