Improving Time-Based Prospective Memory in TBI

Study Overview
=================
Brief Summary
-----------------
This research aims to test aspects of a computer-based cognitive rehabilitation program designed to improve thinking skills in individuals with traumatic brain injury (TBI).

Detailed Description
-----------------
This research aims to test aspects of a computer-based cognitive rehabilitation program designed to improve thinking skills in individuals with traumatic brain injury (TBI), particularly improving the ability to remember to do things in the future.

Official Title
-----------------
Improving Time-Based Prospective Memory in TBI: A Feasibility and Dosing Study

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Behavioral: computer-based cognitive rehabilitation (CBCR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sustained a moderate-to-severe TBI at least one year prior to assessment Fluent in English Demonstrate impairment in strategic cognitive abilities Exclusion Criteria: Significant neurological history other than TBI Significant psychiatric history (e.g., bipolar disorder, schizophrenia) Significant substance abuse history Steroid and/or benzodiazepine use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>The experimental group will receive treatment program designed to train strategic cognitive functions. Sessions will last 50 minutes and take place twice per week for 16 weeks. | Behavioral: computer-based cognitive rehabilitation (CBCR)<br>* Program designed to improve strategic cognitive domains (e.g., complex attention, working memory)<br>|
| No Intervention: Control group<br>The control group will receive no active treatment and will be treated as a no-contact control group. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Tolerability Assessment Scale | visual analog scale to assess participants' tolerability of intervention | baseline through final follow-up assessment (16 weeks) | 
| Recruitment rate percentage | percentage of interested participants who met eligibility criteria via phone screen are eligible at in person screen | phone screen to in-person screen (within 2 weeks) | 
| Retention rate percentage | adherence rate to treatment sessions within 8 weeks (i.e., attendance at 16 sessions), 12 weeks (24 sessions), and 16 weeks (32 sessions) | baseline to mid-intervention assessment #2 (8 weeks), mid-intervention assessment #3 (12 weeks), and final follow-up (16 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in time monitoring & time-based prospective memory | Via a task that simultaneously assesses time monitoring frequency as it relates to time-based prospective memory performance. | 16 weeks | 
| Changes in strategic cognitive functions (performance on NIH EXAMINER) | Via the NIH EXAMINER, a comprehensive computerized battery of tests designed to assess strategic cognitive functioning, particularly related to executive functions and related domains. | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Traumatic Brain Injury, TBI, Brain Injury