Improving Thinking in Everyday Life After Covid-19

NCT04644172 | Completed

• 1 other identifier: IRB-300002814C
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this initial study is to evaluate a new form of cognitive rehabilitation therapy for improving your ability to think, particularly how rapidly you process information that you receive from your senses, e.g., sight, hearing, and smell. The study will also test how often and how well you carry out tasks that rely on thinking in your daily life. You will be randomly assigned to receive the new therapy soon or about three months later. In other words, your treatment schedule will be determined by chance. The new therapy involves intensive, repetitive cognitive exercises (up to 3.5hr/day for 10 consecutive weekdays) with rest periods interspersed as needed.

Conditions

Covid-19; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Canadian Occupation Performance Measure (COPM)

  The COPM is a widely used, transdiagnostic, individualized, structured interview that detects changes over time in a respondent's performance of five, self-selected activities of daily living (ADL). In this case, the instrument will be completed by a family caregiver and only assess instrumental ADL (IADL) with important cognitive components. Performance is rated using 10-point scale that ranges from 1-10 scale points. High scores reflect effective performance. The test score is the mean of the ratings of the five, self-selected IADL.

  Change from Day 0 to Day 17

Secondary Outcomes (3)

• Improved and New Cognitive Ability (INCA)

  Change from Day 0 to Day 17

• Cognitive Task Activity Log (CTAL) How Well Scale

  Change from Day 0 to Day 17

• Cognitive Task Activity Log (CTAL) Independence Scale

  Change from Day 0 to Day 17

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

The treatment will have 3 components. The first component, Speed of Processing Training, is a computer game. Participants identify targets on the screen as rapidly as possible. The second component is training following shaping principles on simulated instrumental activities of daily living (IADL), such as making a telephone call or generating a shopping list, in the treatment setting. Shaping involves progressively increasingly the complexity of a task in incremental steps as a participant gains mastery. Frequent, positive feedback is another important aspect of shaping. The third component is a set of psychological techniques that will help participants apply the improvements from the game to carrying out tasks that rely on thinking in their daily

Behavioral: Speed of Processing Training; Behavioral: Instrumental Activities of Daily Living Shaping; Behavioral: Transfer Package from CI Therapy

Delayed Treatment

OTHER

Participants in this arm will receive testing on the same schedule as the Immediate Treatment up to six-month followup. Delayed Treatment participants will not receive any treatment from the study during this period but will permitted to receive any healthcare that is available on a clinical basis. After six-month followup, participants in this arm will be crossed over to receive the experimental treatment.

Behavioral: Speed of Processing Training; Behavioral: Instrumental Activities of Daily Living Shaping; Behavioral: Transfer Package from CI Therapy; Other: Usual Care

Interventions

Speed of Processing Training BEHAVIORAL

Testing involves trainer-guided practice of computerbased video "games." The "games" require the "player" to identify targets that are presented very briefly. In the first level, 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. SOPT is aimed at improving the fluidity of mental processing speed (not psychomotor reaction time) so that trainees can process more complex information over briefer periods of time. The training involves practice with feedback. The trainer teaches some task-specific strategies, offer suggestions, encouragement, and personalized modification of difficulty for enhancing performance. Speed and task difficulty level are tailored to trainee ability, trainees practice blocks of 16 trials with a goal of achieving performance of 10 to 12 correct trials for each training block.

Also known as: SOPT

Delayed Treatment; Immediate Treatment

Instrumental Activities of Daily Living Shaping BEHAVIORAL

In addition to training on the SOPT software, participants will train on tasks that simulate everyday activities that have important cognitive components (e.g., selecting medicine bottles from a cabinet, measuring ingredients to bake a cake, finding information online). The training will follow shaping principles. Activity periods will be divided into trials of specific length, and the performance of the participant will be measured and graphed to provide the participant with feedback on their performance. Verbal praise will be used to reward a participant for improvements in performance. The difficulty of the task will be increased in small increments as a participant gains mastery. The purpose of this component is to serve as a bridge between the SOPT training, which exercises a basic aspect of cognitiven function, and cognitive function in everyday life, which is embedded in the context of multi-part, and multidimensional tasks.

Also known as: IADL Shaping

Delayed Treatment; Immediate Treatment

Transfer Package from CI Therapy BEHAVIORAL

Behavioral Contract. At the outset of treatment, the therapist negotiates a contract with the participant and caregiver, if one is available.Daily home diary. During treatment, the participants catalog the ADL and IADL for the part of the day spent outside the laboratory. Daily administration of the Cognitive Task Activity Log (CTAL). The CTAL collects information about attempts by the participant to complete ADL and IADL. Problem Solving. The therapist helps participants to think through any barriers to completing ADL and IADL independently. Home skill assignments during treatment. Participants are assigned on a written check-off sheet 10 specific ADL tasks. Home skill assignments after treatment. Toward the end of treatment, a written individualized post-treatment program is developed containing a list of up to 10 IADL for each day of the week. Post-treatment telephone contacts. Participants are contacted during the 12 month period after treatment to evaluate treatment outcomes.

Also known as: Transfer Package (TP)

Delayed Treatment; Immediate Treatment

Usual Care OTHER

Healthcare that is available for adults with cognitive impairment subsequent to COVID-19 in the community on a clinical basis. This includes commercially available, gamified, computerized cognitive training programs.

Delayed Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of cognitive impairment due to Covid-19 infection
• mild-to-moderate general cognitive impairment as determined by a Montreal Cognitive Assessment (MOCA) score between 10-25
• at least 3 months after positive status for Covid-19
• years or older
• medically stable
• sufficiently fit, from both a physical and mental health perspective, to take part in study
• adequate sight and hearing to complete UFOV test
• adequate thinking skills, e.g., ability to follow directions, retain information, to complete UFOV and CTAL, as marked by judgement of the screener that the candidate is able to adequately complete the UFOV and CTAL
• reside in the community (as opposed to a hospital or skilled nursing facility)
• able to travel to laboratory on multiple occasions
• caregiver available

You may not qualify if:

• \- cognitive impairment due to a developmental disability, psychiatric disorder, or substance abuse

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Uswatte G, Taub E, Ball K, Mitchell BS, Blake JA, McKay S, Biney F, Iosipchuk O, Hempfling P, Harris E, Dickerson A, Lokken K, Knight AJ, Mark VW, Agnihotri S, Cutter G. Long COVID brain fog treatment: An early-phase randomized controlled trial of constraint-induced cognitive therapy signals go. Rehabil Psychol. 2025 Apr 28:10.1037/rep0000626. doi: 10.1037/rep0000626. Online ahead of print.

  PMID: 40310209 DERIVED

MeSH Terms

Conditions

COVID-19; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Edward Taub

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychology

Model Details: Pilot RCT with two arms: Immediate and Delayed Treatment with crossover to experimental intervention after 6-month followup. Delayed group is allowed to receive usual care while awaiting crossover. Testing is done for both groups at pre- and post-treatment and 6-month followup.

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: November 25, 2020
• Study Start: January 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: May 15, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)