Improving Thinking in Everyday Life: Pilot Study A

NCT03873844 | Completed

• 1 other identifier: IRB-300002814
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment

Keywords

cognitive processing, transfer package

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Useful Field of View (UFOV)

  Change from Day 0 to Day 28

Other Outcomes (1)

• Timed Instrumental Activities of Daily Living

  Change from Day 0 to Day 28

Study Arms (1)

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.

Behavioral: Speed of Processing Training; Behavioral: Transfer Package from CI Therapy

Interventions

Speed of Processing Training BEHAVIORAL

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.

CI Cognitive Therapy

Transfer Package from CI Therapy BEHAVIORAL

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.

CI Cognitive Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• \- n/a

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Edward Taub

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychology

Model Details: Pilot study. Two baseline assessments precede intervention, which is followed by post-treatment testing.

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 14, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: June 30, 2022
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)