This study will compare two approaches to cognitive rehabilitation in adults with longCOVID with persistent, mild to moderate, cognitive impairment. One approach will feature(A) web-based computer "games" that trains how quickly individuals process informationthat they receive through their senses; (B) in-lab training on everyday activities withimportant cognitive components, (C) procedures designed to transfer improvements incognition from the treatment setting to everyday life, and (D) a non-invasive form ofvagus nerve stimulation (VNS), i.e., trans-auricular VNS (taVNS). Component B willinclude work-related tasks. This approach is termed Constraint-Induced Cognitive Therapy(CICT). The other approach will feature (A) web-based computer "games" that trainreaction time and eye-hand coordination; (B) in-lab training on relaxation, healthynutrition, and healthy sleep, (C) procedures designed to promote integration of theselifestyle changes into everyday life, and (D) taVNS. This approach is termed BrainFitness Training (BFT).A subset of participants, who qualify for and and desire vocational rehabilitation (VR),will receive VR from the Alabama Department of Rehabilitation Services (ADRS) in additionto CICT or BFT. ADRS VR will include career counseling, prescription of on-the-jobaccommodations, and guidance on return-to-work. Those in the CICT + VR group will alsoreceive on-the-job coaching from a peer mentor for a month after completing training.CICT, with or without VR, will involve 30 hours of training. Ten 3-hour in-lab,face-to-face, therapist-directed sessions will be scheduled. These sessions will featureone hour of gaming; the remainder will be committed to in-lab training on the targetbehaviors and the procedures designed to promote transfer of therapeutic gains to dailylife and improving skills essential to work; the set of the latter procedures is termedthe Transfer Package. ta-VNS will administered for 10 minutes before gaming and in-labtarget behavior training. To accommodate the demands of participants' other activities,training sessions will be permitted to be scheduled as tightly as every weekday over 2weeks or as loosely as every other weekday or so over 4 weeks. If a family caregiver isavailable, they will receive training on how to best support participants in theirtherapeutic program. After training ends, four follow-up phone calls will be scheduledapproximately one-week apart with participants to promote integration of the skillsgained during training into everyday life.BFT, with or without VR, will involve 30 hours of training following the same schedule asfor CICT. Ten 3-hour in-lab, face-to-face, therapist-directed sessions will be scheduled.These sessions will feature one hour of gaming; the remainder will be committed to in-labtraining on the target behaviors (healthy sleep, nutrition and relaxation habits) and theprocedures designed to promote transfer of behavior change to daily life. ta-VNS will beadministered for 10 minutes before gaming and in-lab target behavior training. If afamily caregiver is available, they will receive training on how to best supportparticipants in their therapeutic program. After training ends, four follow-up phonecalls will be scheduled approximately one-week apart with participants to promoteintegration of the skills gained during training into everyday life.Participants will be randomly assigned to the interventions. Randomization will bestratified by whether participants qualify for and desire VR from ADRS or not. If yes,participants will be randomized in equal numbers to CICT + VR or BFT + VR. If no,participants will be randomized in equal numbers to CICT or BFT.Testing will happen one month before treatment, one day before treatment, one dayafterwards, and 6- and 12-months afterwards. Outcomes measured will include cognitiveprocessing speed, cognitive function on laboratory tests, and spontaneous performance ofeveryday activities with important cognitive components in daily life. Another importantoutcome measure will be whether or not participants were able to return back to work orhad significant improvements in their work activities.
Not Provided
Behavioral: Processing Speed Training
Speed of processing training involves trainer-guided practice of computer-based video
"games." The games require the "player" to rapidly distinguish targets from decoys, which
trains how rapidly the player processes information received through their senses.
Behavioral: In-lab Instrumental Activities of Daily Living Training
Participant will receive shaping on IADLS. Participants will receive training on everyday
tasks with important cognitive components, in which the difficulty is increased in small
steps over the course of treatment.
Other Name: In-lab IADL Training
Behavioral: In-lab Brain Health Training
Participants will receive training on healthy eating, sleeping, and relaxation techniques
that have been shown to improve brain health.
Other Name: In-lab Stress Management Training
Behavioral: Transfer Package
The Transfer Package was designed to try and bridge the gap between what is trained in
the lab and what the participant does outside of the treatment setting. This components
includes negotiation of a behavioral contract with participants at the outset of
treatment regarding the responsibilities of the participant, family caregivers, if
available, and the treatment team, self-monitoring, assignment of "homework," review of
homework by the trainer, and support of problem-solving by the participant.
Other Name: TP
Behavioral: Follow Up Phone Calls
After completing training, participants will receive four follow up phone calls in the
first month of training. Each call will separated by about a week. The focus of the calls
will incorporating the lessons learnt during treatment into daily life.
Behavioral: Vocational Rehabilitation
In partnership with the Alabama Department of Rehabilitation Services (ADRS),
participants who are eligible may receive vocational rehabilitation. Participants will
receive typical services offered by the ADRS. These could include career counseling,
guidance regarding job retention or return-to-work, and guidance regarding workplace
accommodations.
Behavioral: Peer Mentoring
Participants who are eligible for vocational rehabilitation, and agree will also have a
peer mentor, a co-worker that will be trained by our team, to reinforce strategies the
participant learned during training, and to help the participant problem solve issues
that may arise on the job during the first month after treatment. Peer mentors will meet
with trainers during the month after treatment to make sure procedures are being followed
and address any issues that may arise.
Behavioral: Reaction Time Training
Reaction time training involves trainer-guided practice of computer-based video "games."
Several different games will be featured that train how rapidly "players" react to
"threats" and train eye-hand coordination.
Procedure: Trans-auricular Vagus Nerve Stimulation: High Intensity
The vagus nerve run from the brain to the external ear, throat, chest, and abdomen and
controls, among other functions, the rest and relax response, which supports learning and
turns down inflammatory processes. The rest and relax response can be turned on by
electrically stimulating the vagus nerve. We will place electrodes on the external part
of each ear and safely apply a microcurrent of at least 4 milliamps. Stimulation will
administered for 10 minutes near the start and midway point of each treatment session.
Procedure: Trans-auricular Vagus Nerve Stimulation: Low Intensity
The vagus nerve run from the brain to the external ear, throat, chest, and abdomen and
controls, among other functions, the rest and relax response, which supports learning and
turns down inflammatory processes. The rest and relax response can be turned on by
electrically stimulating the vagus nerve. We will place electrodes on the external part
of each ear and safely apply a microcurrent of less than 4 milliamps. Stimulation will
administered for 10 minutes near the start and midway point of each treatment session.
Inclusion Criteria:
- >3 months post COVID
- mild or greater cognitive impairment
- moderate or greater brain fog
- impairment in performance of daily activities
- reside in community
- reliable transportation to lab
- sufficiently mentally and physically fit
- adequate sight and hearing
- ability to follow directions, and retain information
- sufficient English proficiency
Exclusion Criteria:
- cognitive impairment due to developmental disability, psychiatric disorder, or
substance abuse, TBI or progressive brain disease
- stroke prior to the onset of COVID
- current substance abuse disorder
- prior cognitive processing speed training on DoubleDecision or similar program
- cannot tolerate trans-auricular vagus nerve stimulation
University of Alabama at Birmingham
Birmingham, Alabama, United States
Investigator: Piper Hempfling, MS
Contact: 205-934-9768
pchemp@uab.edu
Investigator: Gitendra Uswatte, PhD
Piper Hempfling, MS
205-934-9768
pchemp@uab.edu
Staci McKay, BS
205-934-9768
stacemc@uab.edu
Gitendra Uswatte, PhD, Principal Investigator
Professor of Psychology, University of Alabama at Birmingham