Improving Thinking in Everyday Life: Pilot Study A

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment
• Intervention / Treatment: Behavioral: Speed of Processing Training; Behavioral: Transfer Package from CI Therapy

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Staci McKay, B.S.; Phone Number: 2059349768; Email: stacemc@uab.edu
• Study Contact Backup: Name: Edward Taub, PhD; Phone Number: 2059342471; Email: etaub@uab.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Change from Day 0 to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Day 0 to Day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed Instrumental Activities of Daily Living	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	Change from Day 0 to Day 28

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Edward Taub, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): March 15, 2028

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: cognitive processing, transfer package
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: IRB-300002814

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