Metacognitive Training to Enhance Strategy Use in Blast-Related TBI

NCT00857207 | Completed Results

• 1 other identifier: B0902-W
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Enhanced Goal Management Training (GMT) is a 10-week group or individual therapy that teaches strategies to improve an individual's ability to complete everyday tasks. This research study will test the effect of GMT on 36 OEF/OIF Veterans compared to a control group of 16 OEF/OIF Veterans receiving a Brain Health Workshop. The results will provide information to conduct future research with a larger group of patients or to identify which patients demonstrate more benefit from the training.

Conditions

Brain Concussion; Blast Injuries

Keywords

Cognitive Therapy; Outcomes Assessment

Outcome Measures

Primary Outcomes (1)

• Computerized Tower Of London (cTOL)

  a computerized program in which patients are shown two pictures simultaneously of a goal board and a test board and are instructed to use the fewest possible moves to match the two boards within 60 seconds. Each baseline and 10 week set of 30 problems consists of the same number of 4, 5, 6 or 7 move problems and has the same average difficulty level. The dependent variables are the total time spent solving the problem (0-60 seconds for each problem; less time is better) and the proportion of optimal moves (toward the goal 0-1 with 1 being the best outcome) and time to first move (0-60 seconds with more planning time indicating better outcome).

  Baseline, 10 weeks

Secondary Outcomes (2)

• BRIEF-A

  Baseline, 10 weeks

• cTOL Optimal Moves

  baseline, 10 weeks

Study Arms (2)

Arm 1: Treatment Goal Management Training

EXPERIMENTAL

Treatment Goal Management Training

Behavioral: Goal Management Training

Arm 2: Control-Brain Health Workshop

NO INTERVENTION

Control-Brain Health Workshop

Interventions

Goal Management Training BEHAVIORAL

Enhanced Goal Management Training is a 10-week group therapy that teaches strategies to improve an individual's ability to complete everyday tasks.

Arm 1: Treatment Goal Management Training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• incidences of blast-related mTBI according to the American Congress of Rehabilitation Medicine, any of three following criteria:
• loss of consciousness \<30 minutes, a Glasgow Coma Scale of 13
• loss of memory for events immediately before and after the event (24 hours alteration of mental state at the time of accident)
• focal neurological deficits that may, or may not, be transient (ACRM, 1993)
• Diagnosis must be documented in the medical record by a physician or neuropsychologist.
• Frontal Lobe impairment will be determined by 1.5 standard deviations below the mean on either the D-KEFS Color Word Interference Testorthe EXAMINER composite score.
• Age 18 to 55 years.
• At least 6 months post injury.
• Family member or friend that is willing to answer questionnaires and provide feedback on questionnaires and completion of homework.

You may not qualify if:

• History of pre-morbid learning disability.
• History of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization.
• Neurological disease unrelated to TBI (seizure disorder, stroke, ADHD).
• Score \< 90 on National Adult Reading Test.
• Failure of validity testing on the Test of Memory Malingering (TOMM)
• Reported alcohol or substance abuse within the past year, or such abuse documented in medical record.
• Reported involvement in current litigation.
• Changes within the past month of medications known to affect cognitive functions e.g. benzodiazepines, opioids, antidepressants and antipsychotics.
• Currently enrolled in other cognitive therapy that cannot be discontinued.
• Not fluent in English.
• Not competent to provide consent (also, not able to demonstrate understanding of expectations of study and potential risks of participation).
• Patients who receive \> 5 hours of therapy from a mental health specialist during the study will not be included in the final analysis.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

Related Publications (1)

• Waid-Ebbs JK; BCBA-D; Daly J, Wu SS, Berg WK, Bauer RM, Perlstein WM, Crosson B. Response to goal management training in veterans with blast-related mild traumatic brain injury. J Rehabil Res Dev. 2014;51(10):1555-66. doi: 10.1682/JRRD.2013.12.0266.

  PMID: 25860148 RESULT

MeSH Terms

Conditions

Brain Concussion; Blast Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Barotrauma

Limitations and Caveats

recruitment of the anticipated number of participants per arm was not reached due to the unexpected closure of one of the recruitment sites. The data analysis was conducted by combining participants from two pilot studies and the randomized study to increase the number of participants.

Results Point of Contact

• Title: Julia Kay Waid-Ebbs, Health Science Specialist
• Organization: Malcom Randall VAMC

Julia.Waid-Ebbs@va.gov

352-871-0282

Study Officials

• Julia K. Waid-Ebbs, PhD

  North Florida/South Georgia Veterans Health System, Gainesville, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: October 1, 2013
• Primary Completion: December 23, 2019
• Study Completion: December 23, 2019
• Last Updated: March 30, 2021
• Results First Posted: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)