Improving Thinking in Everyday Life After Covid-19

May 23, 2024 updated by: Gitendra Uswatte, University of Alabama at Birmingham

Improving Thinking in Everyday Life: Pilot Study C

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this pilot study is to develop and test an intervention for slow processing of sensory input that not only increases the speed of processing but also produces improvement in how much and how well adults with this type of cognitive impairment carry out everyday tasks that rely on cognitive function. The intervention will combine Speed of Processing Training (SOPT) with a modified form of the Transfer Package (TP) from Constraint-Induced Movement therapy (CI therapy). SOPT has been shown to increase speed of processing in a variety of patient populations. The Transfer Package has been shown to produce transfer of gains from the treatment setting to everyday life when combined with training of arm use in the treatment in adults after stroke.

This early phase, randomized controlled trial (RCT) will have two arms: Immediate SOPT+TP (experimental group) and Delayed SOPT+TP (control group). The Immediate SOPT+TP group will receive the experimental intervention immediately after pre-treatment testing, and then be followed for a year. The Delayed SOPT+TP group will receive testing on the same schedule as the Immediate group up to 3-month follow-up. Delayed group participants will be permitted to receive care that is available in the community as part of typical clinical care during this period. After 3-month follow-up testing, Delayed group participants will receive the experimental intervention and then be followed up for a year. Thus, the study design is a RCT with a usual care control group featuring crossover to the experimental intervention for that group at 3 month follow-up.

In the experimental intervention, the length of each treatment session will vary from 2 to 3.5 hours per day, the number of treatment days per week will range from 2 to 5, and the number of weeks of treatment will range from 2 to 10. Accordingly, the interval between testing occasions may change depending on the findings from initial pilot work. Total hours of treatment will not exceed 35. Ranges are given rather than precise values because part of the purpose of this pilot work is to decide, on a preliminary basis, what is the best schedule of delivery. In addition, four follow-up telephone calls will be conducted each week for the first month after the end of treatment. Then, a follow-up telephone call will be placed once a month for up to 11 months. These telephone calls will permit elements of the Transfer Package to be delivered remotely, helping the patient to transition from taking part in treatment to living their daily lives. Each telephone call will last 30 to 60 minutes.

If a caregiver is available, the caregiver will be asked to complete interviews about the participant's progress (see below) and will be invited to support the participant in following the Transfer Package elements of the treatment (see below).

The outcomes that will be assessed are: speed of processing, performance of instrumental activities of daily living (IADL) that place demands on cognitive activity in the laboratory setting, and performance of IADL that place demands on cognitive activity outside the laboratory setting.

The diagram immediately below shows the treatment and testing schedule for the Immediate Treatment group.

Informed Consent Interview → Screening → Pre-treatment Testing → Treatment (2-10 weeks) → Post-treatment testing → up to 4 weekly follow-up phone calls → up to 2 monthly follow-up phone calls → 3-month follow-up testing → up to 9 monthly follow-up calls → 12-month follow-up testing

The diagram immediately below show the treatment and testing schedule for the Delayed Treatment group.

Informed Consent Interview → Screening → Baseline Testing 1 → Usual care (2-10 weeks) → Baseline Testing 2 → 3 months → Pre-treatment Testing → Treatment (2-10 weeks) → Post-treatment testing → up to 4 weekly follow-up phone calls → up to 2 monthly follow-up phone calls → 3-month follow-up testing → up to 9 monthly follow-up calls → 12-month follow-up testing

Repeated measures analysis of variance models with a between-subjects factor will be used to evaluate if statistically significant improvements take place as a result of treatment. The primary comparison will be between the Immediate Treatment and Delayed Treatment groups at post-treatment. The cross-over design permits a another, secondary evaluation of the efficacy of the experimental intervention by comparing the usual care to the SOPT+TP period in the Delayed Treatment group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Edward Taub, Ph.D.
  • Phone Number: 205-934-2471
  • Email: etaub@uab.edu

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 18 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immediate Treatment
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: Transfer Package from CI Therapy
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.
Other Names:
  • Transfer Package (TP)
Behavioral: Speed of Processing Training
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.
Other Names:
  • SOPT
Behavioral: Instrumental Activities of Daily Living Shaping
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.
Other Names:
  • IADL Shaping
Other: Delayed Treatment
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: Transfer Package from CI Therapy
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.
Other Names:
  • Transfer Package (TP)
Behavioral: Speed of Processing Training
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.
Other Names:
  • SOPT
Behavioral: Instrumental Activities of Daily Living Shaping
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.
Other Names:
  • IADL Shaping
Other: Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Canadian Occupation Performance Measure (COPM)
Time Frame: Change from Day 0 to Day 17
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improved and New Cognitive Ability (INCA)
Time Frame: Change from Day 0 to Day 17
The INCA gathers a comprehensive record of participant changes in everyday Instrumental Activities of Daily Living (IADL) with important cognitive components that have been observed since the start of training. These can be reported by the participant (when possible), the caregiver, or other friends and family that have spent time with the participant. The test score is a count; it is the number of new and improved activities with important cognitive components that a participant has been observed to undertake in their daily life since beginning training. The range is 0 to infinite.
Change from Day 0 to Day 17
Cognitive Task Activity Log (CTAL) How Well Scale
Time Frame: Change from Day 0 to Day 17
The CTAL quantifies how well and independently participants complete activities of daily living (ADL) and instrumental ADL (IADL) outside the treatment setting. Twenty-two activities with important cognitive components are surveyed; each is rated by the family caregiver using 11-point scales. The How Well Scale is reported here. The range is 0-5 scale points; high scores reflect effective performance of the activities.
Change from Day 0 to Day 17
Cognitive Task Activity Log (CTAL) Independence Scale
Time Frame: Change from Day 0 to Day 17
The CTAL quantifies how well and independently participants complete activities of daily living (ADL) and instrumental ADL (IADL) outside the treatment setting. Twenty-two activities with important cognitive components are surveyed; each is rated by the family caregiver using 11 point scales. The Independence Scale is reported. The range is 0-5 scale points; high scores reflect performance of the activities without assistance from others.
Change from Day 0 to Day 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edward Taub, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-300002814C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is pilot study. A major purpose of this study is simply to develop the intervention. Sharing individual data is premature.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid-19

Clinical Trials on Transfer Package from CI Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings