Covid-19NCT04644172
Improving Thinking in Everyday Life After Covid-19
A study testing Speed of Processing Training, Instrumental Activities of Daily Living Shaping and Transfer Package from CI Therapy in people with Covid-19 and Cognitive Impairment, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19, Cognitive Impairment
- What is being tested?
- Speed of Processing Training, Instrumental Activities of Daily Living Shaping and Transfer Package from CI Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- cognitive impairment due to a developmental disability, psychiatric disorder, or substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid-19, Cognitive Impairment
- Being tested
- Speed of Processing Training, Instrumental Activities of Daily Living Shaping, Transfer Package from CI Therapy, Usual Care
- Medical subject headings
- COVID-19, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speed of Processing TrainingBehavioural
Also called SOPT
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.
Instrumental Activities of Daily Living ShapingBehavioural
Also called IADL 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.
Transfer Package from CI TherapyBehavioural
Also called Transfer Package (TP)
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.
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Speed of Processing Training; Behavioral: Instrumental Activities of Daily Living Shaping; Behavioral: Transfer Package from CI Therapy; Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Day 0 to Day 17
Secondary outcomes (3)
Improved and New Cognitive Ability (INCA)
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.
Measured: Change from Day 0 to Day 17
Cognitive Task Activity Log (CTAL) How Well Scale
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.
Measured: Change from Day 0 to Day 17
Cognitive Task Activity Log (CTAL) Independence Scale
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.
Measured: Change from Day 0 to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Jan 2021
- Primary completion30 Sep 2022
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gitendra Uswatte, University of Alabama at Birmingham
- Investigators
- Edward Taub, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644172
- Sponsor's protocol ID
- IRB-300002814C
- Status last verified
- May 2024
- First submitted
- 23 Nov 2020
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is pilot study. A major purpose of this study is simply to develop the intervention. Sharing individual data is premature.
Publications
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. 2026 Feb;71(1):46-61. doi: 10.1037/rep0000626. Epub 2025 Apr 28.
PubMed 40310209
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Thinking in Everyday Life: Pilot Study C
- ClinicalTrials.gov ID
- NCT04644172
- Acronym / sponsor ID
- IRB-300002814C
- Conditions
- Covid-19, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Behavioral: Speed of Processing Training, Behavioral: Instrumental Activities of Daily Living Shaping, Behavioral: Transfer Package from CI TherapyThe 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 |
| Delayed Treatment | Other | Behavioral: Speed of Processing Training, Behavioral: Instrumental Activities of Daily Living Shaping, Behavioral: Transfer Package from CI Therapy, Other: Usual CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (1 listed)
- cognitive impairment due to a developmental disability, psychiatric disorder, or substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speed of Processing TrainingAlso: SOPTTesting 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. | Behavioural | Delayed Treatment, Immediate Treatment |
| Instrumental Activities of Daily Living ShapingAlso: IADL ShapingIn 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. | Behavioural | Delayed Treatment, Immediate Treatment |
| Transfer Package from CI TherapyAlso: Transfer Package (TP)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. | Behavioural | Delayed Treatment, Immediate Treatment |
| Usual CareHealthcare 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. | Other | Delayed Treatment |
Primary outcome
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.
3 secondary outcomes
Improved and New Cognitive Ability (INCA)
Time frame: Change from Day 0 to Day 17
Cognitive Task Activity Log (CTAL) How Well Scale
Time frame: Change from Day 0 to Day 17
Cognitive Task Activity Log (CTAL) Independence Scale
Time frame: Change from Day 0 to Day 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Derived from this study: PubMed 40310209Uswatte 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. 2026 Feb;71(1):46-61. doi: 10.1037/rep0000626. Epub 2025 Apr 28.
- Individual participant dataSharing planned: No. This is pilot study. A major purpose of this study is simply to develop the intervention. Sharing individual data is premature.
Related trials for Covid-19
RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
Active, not recruitingPhase 2
COVID-FISETIN: Pilot in SARS-CoV-2 of Fisetin to Alleviate Dysfunction and Inflammation
Covid19
RecruitingObservational study
Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health
Post-Coronavirus Disease 19
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Enrolling by invitationObservational study
Prescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic
Dementia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Taub principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speed of Processing Training, Instrumental Activities of Daily Living Shaping and Transfer Package from CI Therapy in people with Covid-19 and Cognitive Impairment, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupation Performance Measure (COPM) (time frame: Change from Day 0 to Day 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04644172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.