Improving Time-Based Prospective Memory in TBI (TBPM)
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|ClinicalTrials.gov Identifier: NCT04065477|
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : October 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Behavioral: computer-based cognitive rehabilitation (CBCR)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Masking Description:||Study staff conducting baseline and follow-up assessments will be blind as to which group participants are placed. Study staff conducting intervention sessions will be blind to participants' baseline and follow-up assessment performance.|
|Official Title:||Improving Time-Based Prospective Memory in TBI: A Feasibility and Dosing Study|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2021|
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)
Program designed to improve strategic cognitive domains (e.g., complex attention, working memory)
No Intervention: Control group
The control group will receive no active treatment and will be treated as a "no-contact control" group.
- Intervention Tolerability Assessment Scale [ Time Frame: baseline through final follow-up assessment (16 weeks) ]visual analog scale to assess participants' tolerability of intervention
- Recruitment rate percentage [ Time Frame: phone screen to in-person screen (within 2 weeks) ]percentage of interested participants who met eligibility criteria via phone screen are eligible at in person screen
- Retention rate percentage [ Time Frame: baseline to mid-intervention assessment #2 (8 weeks), mid-intervention assessment #3 (12 weeks), and final follow-up (16 weeks) ]adherence rate to treatment sessions within 8 weeks (i.e., attendance at 16 sessions), 12 weeks (24 sessions), and 16 weeks (32 sessions)
- Changes in time monitoring & time-based prospective memory [ Time Frame: 16 weeks ]Via a task that simultaneously assesses time monitoring frequency as it relates to time-based prospective memory performance.
- Changes in strategic cognitive functions (performance on NIH EXAMINER) [ Time Frame: 16 weeks ]Via the NIH EXAMINER, a comprehensive computerized battery of tests designed to assess strategic cognitive functioning, particularly related to executive functions and related domains.
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): NCT04065477
|Contact: Michael G Di Benedetto, MAfirstname.lastname@example.org|
|Contact: Erica Weber, PhDemail@example.com|
|United States, New Jersey|
|East Hanover, New Jersey, United States, 07936|
|Contact: Michael Di Benedetto, MA 973-324-8391 firstname.lastname@example.org|
|Contact: Nancy Moore, MA 973-324-8450 email@example.com|
|Sub-Investigator: Nancy D Chiaravalloti, PhD|
|Principal Investigator: Erica Weber, PhD|
|Sub-Investigator: John DeLuca, PhD|
|Principal Investigator:||Erica Weber, PhD||Kessler Foundation|