Symptom-Targeted Approach to Rehabilitation for Concussion

NCT05091970 | Completed

• 2 other identifiers: DoD Award: PT17006W81XWH1820070
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

Throughout the course of the wars in Iraq and Afghanistan, more than 250,000 service members sustained traumatic brain injuries, mostly characterized as mild traumatic brain injuries (mTBI) or concussions. While most with mTBI recover over days to weeks, a significant percentage continue to experience post-concussive symptoms such as headaches, cognitive difficulties, and dizziness for months to years. As a result, treatment of post-concussive symptoms after mTBI is of significant importance in the Department of Defense and Veterans healthcare systems. Several studies have shown that cognitive rehabilitation can be effective for individuals with mTBI, including Service Members and Veterans with post concussive symptoms. Cognitive rehabilitation is a type of treatment in which patients work with a therapist to improve everyday memory and thinking skills and develop strategies to reduce the impact of cognitive difficulties in their everyday lives. While these treatments have great potential benefits, protocols studied to date are time intensive, requiring up to 60 hours of treatment. These time demands are impractical for many Service Members and Veterans, and place a time-burden on clinics providing the treatment. The current study proposes to identify key ingredients of an evidence-based cognitive rehabilitation protocol to develop a streamlined version that is feasible and acceptable to Service Members and Veterans. This briefer protocol will increase the number of Service Members and Veterans who can access treatment. To accomplish this goal the investigators will first spend six months analyzing manualized treatments from a successful cognitive rehabilitation intervention developed for Service Members. The investigators will analyze manuals using a framework developed to identify active ingredients in rehabilitation. Based on those results the investigators will develop a manualized streamlined treatment protocol, which the investigators will deliver to 25 Service Members and 50 Veterans over 18 months in person or via telehealth. The investigators will determine feasibility and acceptability of this intervention, and collect preliminary efficacy data. The project addresses access to therapy services and enhanced treatment compliance, a key barrier to participation in cognitive rehabilitation by Veterans and Service Members with TBI. Additionally, although this study focuses on Service Members and Veterans with mTBI, the investigators expect that this streamlined intervention can also be translated to civilian populations with mTBI.

Conditions

Mild Traumatic Brain Injury

Keywords

blast injuries; clinical trial; cognitive rehabilitation; concussion; mild TBI; postconcussive syndrome; posttraumatic stress disorder; traumatic brain injury

Outcome Measures

Primary Outcomes (5)

• Goal Attainment Scaling Change

  Goal attainment scaling of a minimum of three goals. Score obtained for each goal at each session. Score ranges from -1 to +3. Higher numbers indicate higher levels of goal achievement.

  Treatment week 1, Treatment week 2, Treatment week 3, 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment

• Common Concussive Cognitive Complaints (C4) Inventory Change

  23 item self-report measure that lists common post-concussive cognitive complaints. The respondent rates how often specific cognitive complaints have caused trouble for them day-to-day in the two weeks preceding the measure's administration. Item scores range from 1 = "Not at All" to 5 = "All the time"

  Baseline; Treatment week 3 (last session); 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment

• Neurobehavioral Symptom Inventory (NSI) Change

  22-item self-report checklist of persistent post-concussive symptoms and how much symptoms have disturbed the respondent since injury. Total score ranges from 0 to 88. Item response options range from 0="None" to 4 ="Very Severe"

  Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment

• Key Behaviors Change Inventory (KBCI)

  The KBCI was designed to assess functional cognitive and behavioral changes after TBI. It is composed of 64 items rated on a 4-point scale. Response options range from "False, not at all" to "Very True"

  Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment

• Patient Global Impression of Change (PGIC)

  Change in activity, limitations, symptoms, emotions and overall quality of life, related to painful illness. Respondents rate impression of change from 1-7, with higher scores indicating an impression of positive change, and to rate overall change on a scale ranging from 1 = "Much Better" to 10 = "Much Worse"

  Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment

Secondary Outcomes (8)

• Center for Epidemiological Studies-Depression (CES-D)

  Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment

• Veterans Rand 36-Item Health Survey (VR-36)

  Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment

• Epworth Sleepiness Scale - Adult Version (ESS)

  Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment

• PTSD Checklist 5 (PCL-5)

  Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment

• Acceptability of Intervention Measure (AIM)- (Patient)

  Treatment session 1(week 1), Treatment session 2 (week 1), Last Treatment session(week 3), 1 week post-treatment, 3 months post-treatment

Study Arms (2)

In-Person

EXPERIMENTAL

Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) delivered face-to-face.

Procedure: Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI)

Telehealth

EXPERIMENTAL

Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) delivered via telehealth.

Procedure: Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI)

Interventions

Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) PROCEDURE

Three 60-minute sessions per week with a minimum of 6 sessions and a maximum of 10 sessions. This intervention is to be delivered by trained Occupational Therapists (OTs) and Speech-Language Pathologists (SLPs), and includes training in compensatory strategies, direct training of cognitive subskills (e.g., attention training), and assigned homework to practice skills learned in treatment.

In-Person; Telehealth

Eligibility Criteria

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

You may qualify if:

• mTBI defined per the VA/DoD Clinical Practice Guideline for the Management of Concussion-Mild Traumatic Brain Injury (CPG; Corrigan \& Bogner, 2007) sustained in any context (deployment-related or non-deployment-related) and at any time longer than 6 months previously;
• A score of 3, 4, or 5 on any of the four Cognitive items on the NSI, to include participants who have cognitive complaints; and
• A score on the Word Reading Subtest of the Wide Range Achievement Test of a sixth-grade reading level or higher, to ensure participants can read study materials.

You may not qualify if:

• History of TBI (any severity) within 6 months of enrollment.
• History of a moderate, severe, or penetrating TBI as defined by DoD/VA guidelines.
• Lifetime diagnosis of schizophrenia or other psychotic disorder.
• Current participation in intensive behavioral health treatment (\>5 appointments/encounters per week) for major depressive disorder, post-traumatic stress disorder (PTSD), bipolar disorder, or substance-related disorder.
• History of a neurological disease other than mild TBI such as multiple sclerosis, cerebral vascular accident, brain tumor, neurodegenerative disease, or neuro-motor disorder.
• Current, active suicidal or homicidal ideation.
• A score of \<45 on Trial 2 of the Test of Memory Malingering, or a Validity 10 score of \>22 from the NSI, to exclude individuals who demonstrate suboptimal effort or potential invalid self-reporting of symptoms.
• Daily use of narcotic pain medications.

Sponsors & Collaborators

• South Texas Veterans Health Care System: lead
• Brooke Army Medical Center: collaborator
• McMaster University: collaborator

Study Sites (2)

Brooke Army Medical Center

San Antonio, Texas, 78219, United States

Location

South Texas Veterans Health Care System

San Antonio, Texas, 78229, United States

Location

Related Publications (32)

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MeSH Terms

Conditions

Brain Concussion; Blast Injuries; Post-Concussion Syndrome; Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Blessen C Eapen, MD

  South Texas Veterans Health Care System

  PRINCIPAL INVESTIGATOR

• Amy O. Bowles, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

• Doug B Cooper, PhD

  South Texas Veterans Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Physical Medicine and Rehabilitation Service

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 25, 2021
• Study Start: November 10, 2021
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)