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Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05091970
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : May 13, 2022
Sponsor:
Collaborators:
Brooke Army Medical Center
McMaster University
Information provided by (Responsible Party):
Blessen Eapen, South Texas Veterans Health Care System

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.


Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Procedure: Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Symptom-Targeted Approach to Rehabilitation for Concussion: STAR-C
Actual Study Start Date : November 10, 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: In-Person
Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) delivered face-to-face.
Procedure: Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI)
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.

Experimental: Telehealth
Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) delivered via telehealth.
Procedure: Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI)
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.




Primary Outcome Measures :
  1. Goal Attainment Scaling Change [ Time Frame: Treatment week 1, Treatment week 2, Treatment week 3, 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment ]
    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.

  2. Common Concussive Cognitive Complaints (C4) Inventory Change [ Time Frame: Baseline; Treatment week 3 (last session); 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment ]
    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"

  3. Neurobehavioral Symptom Inventory (NSI) Change [ Time Frame: Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment ]
    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"

  4. Key Behaviors Change Inventory (KBCI) [ Time Frame: Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment ]
    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"

  5. Patient Global Impression of Change (PGIC) [ Time Frame: Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment ]
    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"


Secondary Outcome Measures :
  1. Center for Epidemiological Studies-Depression (CES-D) [ Time Frame: Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment ]
    The CES-D is a 20 item self-report measure that asks respondents to rate how often in the past week they have felt symptoms related to depression on the following scale: 0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time. Positive items are reverse scored. Scores range from 0 to 60. Higher scores indicate a higher number of more frequent depressive symptoms.

  2. Veterans Rand 36-Item Health Survey (VR-36) [ Time Frame: Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment ]
    36 item self-report measure that assesses level of health in domains of physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, energy/vitality, social functioning, role limitations due to emotional problems, and mental health. Higher scores indicate better ratings of health.

  3. Epworth Sleepiness Scale - Adult Version (ESS) [ Time Frame: Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment ]
    The ESS is an 8-item scale that measures daytime sleepiness. Total score ranges from 0-24, with higher ratings corresponding to higher daytime sleepiness.

  4. PTSD Checklist 5 (PCL-5) [ Time Frame: Baseline; 1 week post-treatment, 4 weeks post-treatment, 12 weeks post-treatment ]
    The PTSD Checklist for DSM-5 is a 20-item self-report measure that screens for PTSD symptoms. Total score ranges from 0-80. A higher score indicates greater presence and intensity of symptoms.

  5. Acceptability of Intervention Measure (AIM)- (Patient) [ Time Frame: Treatment session 1(week 1), Treatment session 2 (week 1), Last Treatment session(week 3), 1 week post-treatment, 3 months post-treatment ]
    Acceptability ratings by patients. Scale is composed of four items rated by clinicians on a 5-point Likert scale ranging from "1 = Completely Disagree" to "5 = Completely Agree."

  6. Acceptability of Intervention Measure (AIM)- (Clinician) [ Time Frame: Treatment session 1(week 1), Treatment session 2 (week 1), Last Treatment session(week 3), 1 week post-treatment ]
    Acceptability ratings by clinicians. Scale is composed of four items rated by clinicians on a 5-point Likert scale ranging from "1 = Completely Disagree" to "5 = Completely Agree."

  7. Intervention Appropriateness Measure (IAM) [ Time Frame: Treatment session 1(week 1), Treatment session 2 (week 1), Last Treatment session(week 3), 1 week post-treatment ]
    Appropriateness ratings by clinicians. Scale is composed of four items rated by clinicians on a 5-point Likert scale ranging from "1 = Completely Disagree" to "5 = Completely Agree."

  8. Feasibility of Intervention Measure (FIM) [ Time Frame: Treatment session 1(week 1), Treatment session 2 (week 1), Last Treatment session(week 3), 1 week post-treatment ]
    Feasibility ratings by clinicians. Scale is composed of four items rated by clinicians on a 5-point Likert scale ranging from "1 = Completely Disagree" to "5 = Completely Agree."



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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;
  2. 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
  3. 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.

All individuals in this study population must meet all of the inclusion criteria in order to be eligible to participate in the study

Exclusion Criteria:

  1. History of TBI (any severity) within 6 months of enrollment.
  2. History of a moderate, severe, or penetrating TBI as defined by DoD/VA guidelines.
  3. Lifetime diagnosis of schizophrenia or other psychotic disorder.
  4. 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.
  5. History of a neurological disease other than mild TBI such as multiple sclerosis, cerebral vascular accident, brain tumor, neurodegenerative disease, or neuro-motor disorder.
  6. Current, active suicidal or homicidal ideation.
  7. 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.
  8. Daily use of narcotic pain medications.

All individuals in this study population meeting any of the exclusion criteria at baseline will be excluded from study participation.


Information from the National Library of Medicine

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): NCT05091970


Contacts
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Contact: Emily J Scarlett, MS 210-916-8693 emily.j.scarlett.ctr@mail.mil
Contact: Kimberly Forcier, MS, LPC 210-617-5300 ext 18170 kimberly.forcier@va.gov

Locations
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United States, Texas
Brooke Army Medical Center Recruiting
San Antonio, Texas, United States, 78219
Contact: Amy Bowles, MD         
South Texas Veterans Health Care System Recruiting
San Antonio, Texas, United States, 78229
Contact: Douglas Cooper, PhD         
Sponsors and Collaborators
South Texas Veterans Health Care System
Brooke Army Medical Center
McMaster University
Investigators
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Principal Investigator: 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
Publications:
Center, DaVBI. DoD Worldwide Numbers for TBI. Defense and Veterans Brain Injury Center. 2017;Retrieved from http://dvbic.dcoe.mil/dod-worldwide-numbers-tbi
Cicerone, KD., Kalmar, K. Persistent postconcussion syndrome: The structure of subjective complaints after mild traumatic brain injury. The Journal of Head Trauma Rehabilitation, 1995;10(3): 1-17.
Keith, RA., Lipsey, MW. The role of theory in rehabilitation assessment, treatment, and outcomes. In RL, Glueckauf, LB, Sechrest, GR, Bond, & EC, McDonel, eds., Improving Assessment in Rehabilitation and Health. Thousand Oaks, CA: Sage Publications; 1993:33-58.
Madden, R., Sykes, C., & Bedirhan Ustun, T. World Health Organization Family of International Classifications: Definition, scope and purpose. 2007. Retrieved from http://www.who.int/classifications/en/FamilyDocument2007.pdf
Taylor, BC., Campbell, E., Nugent, S., Fletcher, L., Bidelspach, DE., Kehle- Forbes, SM., . . . Sayer, NA. Fiscal Year 2014 VA Utilization Report for Iraq and Afghanistan War Veterans Diagnosed with TBI. 2015. Retrieved from http://www.polytrauma.va.gov/TBIReports/FY14-TBI-DiagnosisHCU-Report.pdf

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Responsible Party: Blessen Eapen, Chief, Physical Medicine and Rehabilitation Service, South Texas Veterans Health Care System
ClinicalTrials.gov Identifier: NCT05091970    
Other Study ID Numbers: DoD Award: PT17006
W81XWH1820070 ( Other Grant/Funding Number: Congressionally Directed Medical Research Programs (CDMRP) )
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Blessen Eapen, South Texas Veterans Health Care System:
blast injuries
clinical trial
cognitive rehabilitation
concussion
mild TBI
postconcussive syndrome
posttraumatic stress disorder
traumatic brain injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating