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Improving Thinking in Everyday Life: Pilot Study A

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03873844
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : May 7, 2019
Information provided by (Responsible Party):
Edward Taub, University of Alabama at Birmingham

Brief 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,… . 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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Behavioral: Speed of Processing Training Behavioral: Transfer Package from CI Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot study. Two baseline assessments precede intervention, which is followed by post-treatment testing.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Thinking in Everyday Life: Pilot Study A
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : March 15, 2025

Arm Intervention/treatment
Experimental: CI Cognitive Therapy
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.
Behavioral: Speed of Processing Training
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.

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.

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. Useful Field of View (UFOV) [ Time Frame: Change from Day 0 to Day 28 ]
    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.

Other Outcome Measures:
  1. Timed Instrumental Activities of Daily Living [ Time Frame: Change from Day 0 to Day 28 ]
    This test measures how rapidly participants can complete five timed tasks that simulate everyday instrumental activities of daily living in the laboratory. Tasks are: 1. finding a telephone number of a specific individual in the telephone directory, 2. finding and correctly counting out 37 cents from a group of coins, 3. finding and reading the ingredients on a food can label, 4. finding two food items in an array of food items simulating a crowded pantry shelf, and 5. finding and reading the directions on a medicine container. The tester records the time required to complete each task. If the participant does not complete the task within the preset time limit, testing for that particular task discontinues. The tester adds a penalty to completion time for the tasks completed with minor errors, transforms the times for each of the tasks into z-scores, and calculates the average of the transformed scores. This test has been validated and was used in a multi-site clinical trial test

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

- n/a

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03873844

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Contact: Staci McKay, B.S. 2059349768
Contact: Edward Taub, PhD 2059342471

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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
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Principal Investigator: Edward Taub University of Alabama at Birmingham

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Responsible Party: Edward Taub, University Professor, Department of Psychology, University of Alabama at Birmingham Identifier: NCT03873844     History of Changes
Other Study ID Numbers: IRB-300002814
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Edward Taub, University of Alabama at Birmingham:
cognitive processing, transfer package
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors