Cognitive ImpairmentNCT03873844
Improving Thinking in Everyday Life: Pilot Study A
A study testing Speed of Processing Training and Transfer Package from CI Therapy in people with Cognitive Impairment, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This is a pilot study at the University of Alabama at Birmingham. The purpose of this initial study is to test how effective a new therapy is for improving participants ability to think, particularly how rapidly they process information that they receive from their senses, e.g., sight, hearing,… . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Speed of Processing Training 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
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 30 Jun 2022
- 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
- impairment in speed of processing. This will determined by a time greater than 100 ms on Task 2 and greater than 300 ms on Task 3 of the Useful Field of View test
- substantial impairment in performance of daily activities. This will be determined by a score of at most 2.5 on the Cognitive Task Activity Log
- presence of a stroke, including vascular dementia, TBI, or cognitive impairment due to other causes
- at least 3 months since brain injury for participants with stroke or TBI
- 18 years or older
- medically stable
Show all 11Show fewer
- 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, i.e., ability to follow directions, retain information, to complete UFOV and CTAL, per judgement of the screener
- reside in the community (as opposed to a hospital or skilled nursing facility)
- able to travel to laboratory on multiple occasions
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
This is a pilot study at the University of Alabama at Birmingham. The purpose of this initial study is to test how effective a new therapy is for improving participants ability to think, particularly how rapidly they process information that they receive from their senses, e.g., sight, hearing,… . The study will also test whether the new therapy improves how often and how well they are able to carry out tasks that rely on thinking in their daily life. The therapy will combine a computer game that ask participants to identify targets on the screen as rapidly as possible with a set of psychological techniques that will help to apply the improvements that are made in how rapidly participants process information as a result of the game to carrying out tasks that rely on thinking in your daily life.
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 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. 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. 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. There will be two baseline testing sessions, followed by post-treatment testing, and testing six months and 12 months after treatment. The two baseline testing sessions will be separated by a week, and will permit any changes observed after treatment to be compared to what takes place when no treatment is provided. In other words, the baseline testing sessions will provide a source of within-subject control. If a caregiver is available, the caregiver will be asked to complete CTAL interviews about the participant (see below) and will be invited to support the participant in following the Transfer Package elements of the treatment (see below). Repeated measures analysis of variance models will be used to evaluate if statistically significant improvements take place as a result of treatment.
- Conditions
- Cognitive Impairment
- Being tested
- Speed of Processing Training, Transfer Package from CI Therapy
- Keywords
- cognitive processing, transfer package
- Medical subject headings
- 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
Speed of Processing Training (SOPT). 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. SOPT has the primary aim of improving the fluid ability of mental processing speed such that trainees can process increasingly more information and increasingly more complex information over briefer periods of time. The training primarily involves practice with feedback. Trainers also offer suggestions, encouragement, and personalized modifications of difficulty for the trainee according to a specified protocol. At a display speed and task difficulty level tailored to their ability, trainees practice blocks of 16 trials. Trainees receive immediate feedback after each trial and see their total correct trials at the end of each block of trials. Trainers tell the trainees that their goal is to achieve performance of 10 to 12 correct trials for each training block.
Transfer Package from CI TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CI Cognitive Therapy | Experimental | The treatment will have 2 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 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 life. Receives: Behavioral: Speed of Processing Training; Behavioral: Transfer Package from CI Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Task Activity Log (CTAL)
The CTAL collects information about attempts by the participant to complete activities of daily living (ADL) and instrumental ADL (IADL).
Measured: Change from Day 0 to Day 28
Secondary outcomes (1)
Useful Field of View (UFOV)
This test is very similar to the SOPT training program (see paragraph on SOPT in Treatment section above). The UFOV Assessment quantifies how rapidly test takers process sensory input. It is well validated test, that is used widely. It has been adopted by Federal and State agencies and insurance companies to assess fitness to drive, which is closely related to speed of processing.
Measured: Change from Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start1 Apr 2019
- Primary completion1 Apr 2020
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study. Two baseline assessments precede intervention, which is followed by post-treatment testing.
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT03873844
- Sponsor's protocol ID
- IRB-300002814
- Status last verified
- May 2024
- First submitted
- 11 Mar 2019
- 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.
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 A
- ClinicalTrials.gov ID
- NCT03873844
- Acronym / sponsor ID
- IRB-300002814
- Conditions
- Cognitive Impairment
- Keywords
- cognitive processing, transfer package
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 14 Mar 2019 (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.
This is a pilot study at the University of Alabama at Birmingham. The purpose of this initial study is to test how effective a new therapy is for improving participants ability to think, particularly how rapidly they process information that they receive from their senses, e.g., sight, hearing,… . The study will also test whether the new therapy improves how often and how well they are able to carry out tasks that rely on thinking in their daily life. The therapy will combine a computer game that ask participants to identify targets on the screen as rapidly as possible with a set of psychological techniques that will help to apply the improvements that are made in how rapidly participants process information as a result of the game to carrying out tasks that rely on thinking in your daily life.
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 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. 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. 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. There will be two baseline testing sessions, followed by post-treatment testing, and testing six months and 12 months after treatment. The two baseline testing sessions will be separated by a week, and will permit any changes observed after treatment to be compared to what takes place when no treatment is provided. In other words, the baseline testing sessions will provide a source of within-subject control. If a caregiver is available, the caregiver will be asked to complete CTAL interviews about the participant (see below) and will be invited to support the participant in following the Transfer Package elements of the treatment (see below). Repeated measures analysis of variance models will be used to evaluate if statistically significant improvements take place as a result of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study. Two baseline assessments precede intervention, which is followed by post-treatment testing.
| Arm | Type | Receives |
|---|---|---|
| CI Cognitive Therapy | Experimental | Behavioral: Speed of Processing Training, Behavioral: Transfer Package from CI TherapyThe treatment will have 2 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 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 life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- impairment in speed of processing. This will determined by a time greater than 100 ms on Task 2 and greater than 300 ms on Task 3 of the Useful Field of View test
- substantial impairment in performance of daily activities. This will be determined by a score of at most 2.5 on the Cognitive Task Activity Log
- presence of a stroke, including vascular dementia, TBI, or cognitive impairment due to other causes
- at least 3 months since brain injury for participants with stroke or TBI
- 18 years or older
Key exclusion criteria (1 listed)
- n/a
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 TrainingSpeed of Processing Training (SOPT). 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. SOPT has the primary aim of improving the fluid ability of mental processing speed such that trainees can process increasingly more information and increasingly more complex information over briefer periods of time. The training primarily involves practice with feedback. Trainers also offer suggestions, encouragement, and personalized modifications of difficulty for the trainee according to a specified protocol. At a display speed and task difficulty level tailored to their ability, trainees practice blocks of 16 trials. Trainees receive immediate feedback after each trial and see their total correct trials at the end of each block of trials. Trainers tell the trainees that their goal is to achieve performance of 10 to 12 correct trials for each training block. | Behavioural | CI Cognitive Therapy |
| Transfer Package from CI TherapyBehavioral 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 | CI Cognitive Therapy |
Primary outcome
Cognitive Task Activity Log (CTAL)
Time frame: Change from Day 0 to Day 28
The CTAL collects information about attempts by the participant to complete activities of daily living (ADL) and instrumental ADL (IADL).
1 secondary outcome
Useful Field of View (UFOV)
Time frame: Change from Day 0 to Day 28
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.
- 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.
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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 and Transfer Package from CI Therapy in people with 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?
Cognitive Task Activity Log (CTAL) (time frame: Change from Day 0 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.