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Long COVID Brain Fog: Cognitive Rehabilitation Trial

Primary Purpose

Long COVID, Brain Fog, Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Speed of Processing Training
In-lab Instrumental Activities of Daily Living Training
In-lab Brain Health Training
Transfer Package
Follow Up Phone Calls
Vocational Rehabilitation
Peer Mentoring
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Long COVID focused on measuring Long COVID, Brain Fog, Cognitive Impairment, Vocational Rehabilitation, COVID-19, PASC, Cognitive Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    CICT

    CICT + VR

    BFT

    BFT + VR

    Arm Description

    Constraint-Induced Cognitive Therapy uses in-lab training on everyday activities with important cognitive components and procedures designed to transfer improvements from the treatment setting to every day life. This will be combined with computer-based Speed of Processing Training.

    Constraint-Induced Cognitive Therapy plus Vocational Rehabilitation uses in-lab training on everyday activities with important cognitive components and procedures designed to transfer improvements from the treatment setting to every day life. This will be combined with computer-based Speed of Processing Training. This group will also receive vocational rehabilitation from the Alabama Department of Rehabilitation Services, such as career counseling and building important career skills.

    Brain Fitness Training involves in-lab training on relaxation, healthy nutrition, and healthy sleep with procedures designed to promote integration of these lifestyles into everyday life. This will be combined with computer-based Speed of Processing Training.

    Brain Fitness Training plus Vocational Rehabilitation involves in-lab training on relaxation, healthy nutrition, and healthy sleep with procedures designed to promote integration of these lifestyles into everyday life. This group will also receive vocational rehabilitation from the Alabama Department of Rehabilitation Services, such as career counseling and building important career skills.

    Outcomes

    Primary Outcome Measures

    Canadian Occupational Performance Measure (COPM)
    The COPM is a standard, validated, trans-diagnostic, patient-centered structured interview which is commonly used to measure the real-world outcome of rehabilitation procedures that span both motor and cognitive functions after stroke. The Performance Scale assesses how well a participant performs five activities in their daily life, i.e., outside the lab, that are important to the participant. Activities, for this purpose, will be restricted to those with an important cognitive component ,i.e., IADL. The 10-point response scale ranges from 1 (not able to do the activity at all) to 10 (able to do the activity extremely well). Performance Scale scores from the participant will be the primary outcome.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 19, 2023
    Last Updated
    October 23, 2023
    Sponsor
    University of Alabama at Birmingham
    Collaborators
    National Institute on Disability, Independent Living, and Rehabilitation Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06095297
    Brief Title
    Long COVID Brain Fog: Cognitive Rehabilitation Trial
    Official Title
    Technique to Enable Return-to-Work by Employees With Long COVID Brain Fog
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham
    Collaborators
    National Institute on Disability, Independent Living, and Rehabilitation Research

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will compare two approaches to cognitive rehabilitation in adults with long COVID with persistent, mild to moderate, cognitive impairment. Both approaches will feature a web-based computer "game" that trains cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. This training is termed Speed of Processing Training (SOPT). One approach will add (A) in-lab training on everyday activities with important cognitive components and (B) procedures designed to transfer improvements in cognition from the treatment setting to everyday life. Component A will include work-related tasks. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will add (A) in-lab training on relaxation, healthy nutrition, and healthy sleep and (B) procedures designed to promote integration of these lifestyle changes into everyday life. This approach is termed Brain Fitness 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 addition to CICT or BFT. ADRS VR will include career counseling, prescription of on-the-job accommodations, and guidance on return-to-work. Those in the CICT + VR group will also receive 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 feature one hour of SOPT; the remainder will be committed to in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life and improving skills essential to work; the set of the latter procedures is termed the Transfer Package. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. If a family caregiver is available, they will receive training on how to best support participants in their therapeutic program. After training ends, four follow-up phone calls will be scheduled approximately one-week apart with participants to promote integration of the skills gained during training into everyday life. BFT, with or without VR, will involve 30 hours of training following the same schedule as for CICT. Ten 3-hour in-lab, face-to-face, therapist-directed sessions will be scheduled. These sessions will feature one hour of SOPT; the remainder will be committed to in-lab training on the target behaviors (healthy sleep, nutrition and relaxation habits) and the procedures designed to promote transfer of behavior change to daily life. If a family caregiver is available, they will receive training on how to best support participants in their therapeutic program. After training ends, four follow-up phone calls will be scheduled approximately one-week apart with participants to promote integration of the skills gained during training into everyday life. Participants will be randomly assigned to the interventions. Randomization will be stratified 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 day afterwards, and 6- and 12-months afterwards. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life. Another important outcome measure will be whether or not participants were able to return back to work or had significant improvements in their work activities.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Long COVID, Brain Fog, Cognitive Impairment, Cognitive Dysfunction, Post-Acute COVID-19 Syndrome
    Keywords
    Long COVID, Brain Fog, Cognitive Impairment, Vocational Rehabilitation, COVID-19, PASC, Cognitive Rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    The tester will masked to group assignment.
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CICT
    Arm Type
    Experimental
    Arm Description
    Constraint-Induced Cognitive Therapy uses in-lab training on everyday activities with important cognitive components and procedures designed to transfer improvements from the treatment setting to every day life. This will be combined with computer-based Speed of Processing Training.
    Arm Title
    CICT + VR
    Arm Type
    Experimental
    Arm Description
    Constraint-Induced Cognitive Therapy plus Vocational Rehabilitation uses in-lab training on everyday activities with important cognitive components and procedures designed to transfer improvements from the treatment setting to every day life. This will be combined with computer-based Speed of Processing Training. This group will also receive vocational rehabilitation from the Alabama Department of Rehabilitation Services, such as career counseling and building important career skills.
    Arm Title
    BFT
    Arm Type
    Active Comparator
    Arm Description
    Brain Fitness Training involves in-lab training on relaxation, healthy nutrition, and healthy sleep with procedures designed to promote integration of these lifestyles into everyday life. This will be combined with computer-based Speed of Processing Training.
    Arm Title
    BFT + VR
    Arm Type
    Active Comparator
    Arm Description
    Brain Fitness Training plus Vocational Rehabilitation involves in-lab training on relaxation, healthy nutrition, and healthy sleep with procedures designed to promote integration of these lifestyles into everyday life. This group will also receive vocational rehabilitation from the Alabama Department of Rehabilitation Services, such as career counseling and building important career skills.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Speed of Processing Training
    Other Intervention Name(s)
    SOPT
    Intervention Description
    Speed of processing training involves trainer-guided practice of computer-based video "games." The "games" require the "player" to identify targets that are presented very briefly. In the first level of difficulty, the player has to identify a target at the center of the screen. In the second level, the player has to identify targets at the center and edge of the screen simultaneously. In the third level, other objects, which serve as decoys, are added. This intervention aims to improve the mental processing speed of participants. Trainees receive immediate feedback at the end of each trial, and rest will be provided after trials if necessary. These "games" will be implemented during training, and participants are also encouraged to practice at home.
    Intervention Type
    Behavioral
    Intervention Name(s)
    In-lab Instrumental Activities of Daily Living Training
    Other Intervention Name(s)
    In-lab IADL Training
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    In-lab Brain Health Training
    Other Intervention Name(s)
    In-lab Stress Management Training
    Intervention Description
    Participants will receive training on healthy eating, sleeping, and relaxation techniques that have been shown to improve brain health.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Transfer Package
    Other Intervention Name(s)
    TP
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Follow Up Phone Calls
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Vocational Rehabilitation
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Peer Mentoring
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Canadian Occupational Performance Measure (COPM)
    Description
    The COPM is a standard, validated, trans-diagnostic, patient-centered structured interview which is commonly used to measure the real-world outcome of rehabilitation procedures that span both motor and cognitive functions after stroke. The Performance Scale assesses how well a participant performs five activities in their daily life, i.e., outside the lab, that are important to the participant. Activities, for this purpose, will be restricted to those with an important cognitive component ,i.e., IADL. The 10-point response scale ranges from 1 (not able to do the activity at all) to 10 (able to do the activity extremely well). Performance Scale scores from the participant will be the primary outcome.
    Time Frame
    Change from Day 30 to Day 60, i.e., from Pre- to Post-treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Piper Hempfling, MS
    Phone
    205-934-9768
    Email
    pchemp@uab.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Staci McKay, BS
    Phone
    205-934-9768
    Email
    stacemc@uab.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gitendra Uswatte, PhD
    Organizational Affiliation
    Professor of Psychology, University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Long COVID Brain Fog: Cognitive Rehabilitation Trial

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