Improving Thinking in Everyday Life: Pilot Study A
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|ClinicalTrials.gov Identifier: NCT03873844|
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Impairment||Behavioral: Speed of Processing Training Behavioral: Transfer Package from CI Therapy||Not Applicable|
|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)|
|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|
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.
- 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).
- 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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03873844
|Contact: Staci McKay, B.S.||email@example.com|
|Contact: Edward Taub, PhDfirstname.lastname@example.org|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Edward Taub||University of Alabama at Birmingham|