Mild Traumatic Brain Injury (mTBI)STAR-CNCT06855186
Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C)
A study testing Symptom-Targeted Approach to Rehabilitation for Concussion in people with Mild Traumatic Brain Injury (mTBI), run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 2 sites in United States.
Trial summary
Purpose: Investigators propose a three-arm RCT across two military treatment facilities:1) in-person STAR-C, 2) telehealth STAR-C, and 3) no treatment control. Outcomes will be assessed immediately and at one- and three-months post treatment. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Mild Traumatic Brain Injury (mTBI)
- What is being tested?
- Symptom-Targeted Approach to Rehabilitation for Concussion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Sep 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- mTBI defined per the VA/DoD Clinical Practice Guideline for the Management of Concussion-Mild Traumatic Brain Injury sustained in any context (deployment related or non-deployment-related) and at any time longer than 3 months previously.
- a score of 2, 3, or 4 on any of the four Cognitive items on the NSI, to include participants who have cognitive complaints.
- 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.
Who cannot join
- History of a moderate, severe, or penetrating TBI as defined by DoD/VA guidelines.
- Lifetime diagnosis of schizophrenia or other psychotic/thought disorder.
- Current participation in intensive behavioral health treatment (≥3 appointments /encounters per week) for any psychiatric or substance use disorder.
- Current participation in other treatments that target cognition within the last two weeks (i.e., healthcare provider-prescribed cognitive rehabilitation in a group or individual format of any time duration or involving digital/game-based format of more than 4 hours per week).
- History of a neurological disease affecting cognitive function, other than mild TBI, such as multiple sclerosis, stroke, brain tumor, or Parkinson Disease.
- Current, active suicidal or homicidal ideation.
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- Daily use of narcotic pain medications.
- Lack of access to technology or internet/cell phone service that supports telemedicine.
- Current participation in other therapy targeting cognition (Note: This is not the same as Cognitive Behavioral Therapy/CBT which addresses psychological issues and may continue during participation in this research project).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brooke Army Medical Center
San Antonio, Texas, 78234
- Recruiting
Desmond T. Doss Health Clinic
Wahiawa, Hawaii, 96786
About this study
Official title: Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C): RCT of In-person vs Telehealth vs Wait List Control
Purpose: Investigators propose a three-arm RCT across two military treatment facilities:1) in-person STAR-C, 2) telehealth STAR-C, and 3) no treatment control. Outcomes will be assessed immediately and at one- and three-months post treatment.
Hypothesis/Objectives: STAR-C, delivered in-person and via telehealth, will be effective in decreasing everyday cognitive complaints among patients with a history of mTBI. Effectiveness will be moderated by patient characteristics. Stakeholder feedback will yield a process map for broad implementation of STAR-C in varied clinical environments.
Read the detailed description
Specific Aim 1 (primary for RCT): To evaluate effectiveness of STAR-C.
Hypothesis 1a: In-Person STAR-C will lead to a greater decrease in everyday cognitive complaints (C4) compared to wait-list control.
Hypothesis 1b: Tele STAR-C will lead to a greater decrease in everyday cognitive complaints (C4) compared to wait-list control.
Specific Aim 2 (secondary): To evaluate maintenance of treatment effects using a practice based evidence approach.
Question 2a: What proportion of in-person STAR-C treatment effects (C4 and GAS) will be maintained at the 3-month follow-up?
Question 2b: What proportion of telehealth STAR-C treatment effects (C4 and GAS) will be maintained at the 3-month follow-up?
Specific Aim 3 (exploratory): To explore factors associated with heterogeneity in treatment response.
Question 3a: What factors prevented participants from achieving a ≥2-point improvement on the C4?
Question 3b: What factors prevented participants from maintaining ≥2-point improvement on the C4?
Question 3c: What factors prevented participants from achieving ≥2 out of 3 targets using GAS?
Question 3d: What factors contributed to participants maintaining or exceeding targets (GAS) at the 3-month follow-up?
Specific Aim 4 (implementation): Use stakeholder input (to include clinicians, administrators, and patients) from capacity assessment and after-action review to generate an implementation package for clinics interested in STAR-C.
Question 4: For what proportion of patients will clinicians rate STAR-C as acceptable, appropriate, and feasible (AIM/IAM/FIM)?
- Conditions
- Mild Traumatic Brain Injury (mTBI)
- Being tested
- Symptom-Targeted Approach to Rehabilitation for Concussion
- Keywords
- concussion, brain injury, cognitive rehabilitation, military, adults
- Medical subject headings
- Brain Concussion, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom-Targeted Approach to Rehabilitation for ConcussionBehavioural
This study is looking at a shortened version of a therapist-direct cognitive rehabilitation intervention, known as STAR-C. STAR-C is focused on strategy use, and for strategy use to become a habit the person must have the opportunity for high-dose spaced practice. Thus, in STAR-C each session includes opportunities for repeated practice and participants schedule practice times between sessions. Sometimes a new strategy requires learning new facts, in which case the clinician chooses ingredients such as self-quizzing or comparing and contrasting outcomes, which are effective for learning new facts and concepts.
| Study group | Role | What they receive |
|---|---|---|
| No Treatment Waitlist | Other | Individuals randomized to this arm will go for 4 weeks without treatment. During this time, participants will be asked to remain stable on treatments that they are already receiving for their concussive symptoms; that is and should not start a new treatment or change their medication. At the end of the 4-week wait, participant's will be asked about any changes to treatments that they have received during this time, and participants will be asked to complete questionnaires. This visit can be complete in person or remotely. Participants will be randomized into the in-person or telemedicine group. Receives: Behavioral: Symptom-Targeted Approach to Rehabilitation for Concussion |
| In-Person STAR-C | Other | Individuals assigned to this treatment will receive in-person individual cognitive rehabilitation treatment conducted by credentialed speech or occupational therapists. Participants will complete up to three sessions per week (approximately 50 minutes each) for up to nine sessions plus one wrap up session. The treatment will include a focus on compensatory strategies and weekly homework assignments. Participants will work on personalized targets and assignments. The treatment will end with one wrap up session where participants will put together a plan for maintenance of what they have learned with their therapist's help. Receives: Behavioral: Symptom-Targeted Approach to Rehabilitation for Concussion |
| Telehealth STAR-C | Other | Individuals assigned to this treatment will receive individual cognitive rehabilitation treatment conducted by credentialed speech or occupational therapists via a telemedicine format. Participants will complete up to three sessions per week (approximately 50 minutes each) for up to nine sessions plus one wrap up session. The treatment will include a focus on compensatory strategies and weekly homework assignments. Participants will work on personalized targets and assignments. The treatment will end with one wrap up session where participants will put together a plan for maintenance of what they have learned with their therapist's help. Receives: Behavioral: Symptom-Targeted Approach to Rehabilitation for Concussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Common Concussive Cognitive Complaints (C4)
On the C4, patients are asked to "identify challenges that are new since your injury and affect your everyday functioning, so we can focus therapy on what is most important to you." For each question, the patient is asked to choose the number that shows how often this has caused problems for them in everyday life in the past two weeks. Responses are on a scale from 1 (not at all) to 5 (all the time). The reliability and validity of the C4 are acceptable (internal consistency of domains: 0.465 to 0.797; 4-week test-retest reliability of domains: 0.628 to 0.832; convergent validity with MMPI-3 Cognitive Complaints and Inefficiency scales and discriminant validity with MMPI-3 Activation and Eating Concerns scales).
Measured: From baseline to 3 months post treatment
Goal Attainment Scaling (GAS)
As described above in the Summary of ongoing relevant clinical trials, in each session, the patient and therapist collaborate to identify a desired outcome for the patient's target and then scale it using a 5-point rating system. The patient's current state relative to the target is assigned a 0 on the scale, achievement of the desired target is +2, partial achievement is +1, and achievement beyond expectations is +3. Success is defined as a GAS score of 2 or 3.
Measured: From treatment week 1 to 3 months post treatment
Secondary outcomes (1)
Evaluate maintenance of treatment effects
Question 2a: At the 3-month follow-up, determine the proportion of in-person STAR-C participants with ≥2 points C4 improvement post treatment maintained their improvement using contingency table or McNemar test. Question 2b: At the 3-month follow-up, determine the proportion of telehealth STAR-C participants with ≥2 points C4 improvement post treatment maintained their improvement using contingency table or McNemar test. Question 2c: At the 1-month and 3-month follow-ups, describe rates of maintaining ≥2 points C4 improvement for the in-person and telehealth STAR-C groups.
Measured: From baseline to 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start18 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (58)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain Injury (mTBI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Brooke Army Medical Center, Tripler Army Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855186
- Sponsor's protocol ID
- C.2024.104d
- Acronym
- STAR-C
- Status last verified
- Jan 2026
- First submitted
- 25 Feb 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Common Concussive Cognitive Complaints (C4); Goal Attainment Scaling (GAS); Audio recordings; Patient Characterization Measures (headache, sleep problems, dizziness, musculoskeletal injury and pain, medications, and use of commercial brain games); Neurobehavioral Symptom Inventory (NSI); Key Behaviors Change Inventory (KBCI); Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5); Patient Health Questionnaire (PHQ-9); Veterans RAND 36 Item Health Survey (VR-36); Epworth Sleepiness Scale (ESS); Feasibility of Intervention Measure (FIM)/Intervention Appropriateness Measure (IAM)/Acceptability of Intervention Measure (AIM); Self Efficacy for Symptom Management (SESx); NIH Toolbox - cognition; Memory Complaints Inventory (MCI); Inventory of Problems (IOP)
Publications
Cicerone KD, Azulay J. Perceived self-efficacy and life satisfaction after traumatic brain injury. J Head Trauma Rehabil. 2007 Sep-Oct;22(5):257-66. doi: 10.1097/01.HTR.0000290970.56130.81.
PubMed 17878767Corrigan JD, Bogner J. Initial reliability and validity of the Ohio State University TBI Identification Method. J Head Trauma Rehabil. 2007 Nov-Dec;22(6):318-29. doi: 10.1097/01.HTR.0000300227.67748.77.
PubMed 18025964Scheffler B, Schimbock F, Scholer A, Rosner K, Spallek J, Kopkow C. Tailored GuideLine Implementation in STrokE Rehabilitation (GLISTER) in Germany. Protocol of a Mixed Methods Study Using the Behavior Change Wheel and the Theoretical Domains Framework. Front Neurol. 2022 Jul 27;13:828521. doi: 10.3389/fneur.2022.828521. eCollection 2022.
PubMed 35968277Gromatsky M, Sullivan SR, Mitchell EL, Spears AP, Edwards ER, Goodman M. Feasibility and acceptability of VA CONNECT: Caring for our nation's needs electronically during the COVID-19 transition. Psychiatry Res. 2021 Feb;296:113700. doi: 10.1016/j.psychres.2020.113700. Epub 2020 Dec 31.
PubMed 33422845Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Kendzerska TB, Smith PM, Brignardello-Petersen R, Leung RS, Tomlinson GA. Evaluation of the measurement properties of the Epworth sleepiness scale: a systematic review. Sleep Med Rev. 2014 Aug;18(4):321-31. doi: 10.1016/j.smrv.2013.08.002. Epub 2013 Aug 22.
PubMed 24135493Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
PubMed 1798888Kazis LE, Ren XS, Lee A, Skinner K, Rogers W, Clark J, Miller DR. Health status in VA patients: results from the Veterans Health Study. Am J Med Qual. 1999 Jan-Feb;14(1):28-38. doi: 10.1177/106286069901400105.
PubMed 10446661Beard C, Hsu KJ, Rifkin LS, Busch AB, Bjorgvinsson T. Validation of the PHQ-9 in a psychiatric sample. J Affect Disord. 2016 Mar 15;193:267-73. doi: 10.1016/j.jad.2015.12.075. Epub 2015 Dec 31.
PubMed 26774513Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Clapp JD, Kemp JJ, Cox KS, Tuerk PW. PATTERNS OF CHANGE IN RESPONSE TO PROLONGED EXPOSURE: IMPLICATIONS FOR TREATMENT OUTCOME. Depress Anxiety. 2016 Sep;33(9):807-15. doi: 10.1002/da.22534. Epub 2016 Jun 20.
PubMed 27321062Wortmann JH, Jordan AH, Weathers FW, Resick PA, Dondanville KA, Hall-Clark B, Foa EB, Young-McCaughan S, Yarvis JS, Hembree EA, Mintz J, Peterson AL, Litz BT. Psychometric analysis of the PTSD Checklist-5 (PCL-5) among treatment-seeking military service members. Psychol Assess. 2016 Nov;28(11):1392-1403. doi: 10.1037/pas0000260. Epub 2016 Jan 11.
PubMed 26751087Bovin MJ, Marx BP, Weathers FW, Gallagher MW, Rodriguez P, Schnurr PP, Keane TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. Psychol Assess. 2016 Nov;28(11):1379-1391. doi: 10.1037/pas0000254. Epub 2015 Dec 14.
PubMed 26653052Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
PubMed 26606250Vanderploeg RD, Belanger HG, Duchnick JD, Curtiss G. Awareness problems following moderate to severe traumatic brain injury: Prevalence, assessment methods, and injury correlates. J Rehabil Res Dev. 2007;44(7):937-50. doi: 10.1682/jrrd.2006.12.0163.
PubMed 18075951
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C): RCT of In-person vs Telehealth vs Wait List Control
- ClinicalTrials.gov ID
- NCT06855186
- Acronym / sponsor ID
- STAR-C / C.2024.104d
- Conditions
- Mild Traumatic Brain Injury (mTBI)
- Keywords
- concussion, brain injury, cognitive rehabilitation, military, adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Brooke Army Medical Center, Tripler Army Medical Center
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: Investigators propose a three-arm RCT across two military treatment facilities:1) in-person STAR-C, 2) telehealth STAR-C, and 3) no treatment control. Outcomes will be assessed immediately and at one- and three-months post treatment.
Hypothesis/Objectives: STAR-C, delivered in-person and via telehealth, will be effective in decreasing everyday cognitive complaints among patients with a history of mTBI. Effectiveness will be moderated by patient characteristics. Stakeholder feedback will yield a process map for broad implementation of STAR-C in varied clinical environments.
Detailed description
Specific Aim 1 (primary for RCT): To evaluate effectiveness of STAR-C.
Hypothesis 1a: In-Person STAR-C will lead to a greater decrease in everyday cognitive complaints (C4) compared to wait-list control.
Hypothesis 1b: Tele STAR-C will lead to a greater decrease in everyday cognitive complaints (C4) compared to wait-list control.
Specific Aim 2 (secondary): To evaluate maintenance of treatment effects using a practice based evidence approach.
Question 2a: What proportion of in-person STAR-C treatment effects (C4 and GAS) will be maintained at the 3-month follow-up?
Question 2b: What proportion of telehealth STAR-C treatment effects (C4 and GAS) will be maintained at the 3-month follow-up?
Specific Aim 3 (exploratory): To explore factors associated with heterogeneity in treatment response.
Question 3a: What factors prevented participants from achieving a ≥2-point improvement on the C4?
Question 3b: What factors prevented participants from maintaining ≥2-point improvement on the C4?
Question 3c: What factors prevented participants from achieving ≥2 out of 3 targets using GAS?
Question 3d: What factors contributed to participants maintaining or exceeding targets (GAS) at the 3-month follow-up?
Specific Aim 4 (implementation): Use stakeholder input (to include clinicians, administrators, and patients) from capacity assessment and after-action review to generate an implementation package for clinics interested in STAR-C.
Question 4: For what proportion of patients will clinicians rate STAR-C as acceptable, appropriate, and feasible (AIM/IAM/FIM)?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Treatment Waitlist | Other | Behavioral: Symptom-Targeted Approach to Rehabilitation for ConcussionIndividuals randomized to this arm will go for 4 weeks without treatment. During this time, participants will be asked to remain stable on treatments that they are already receiving for their concussive symptoms; that is and should not start a new treatment or change their medication. At the end of the 4-week wait, participant's will be asked about any changes to treatments that they have received during this time, and participants will be asked to complete questionnaires. This visit can be complete in person or remotely. Participants will be randomized into the in-person or telemedicine group. |
| In-Person STAR-C | Other | Behavioral: Symptom-Targeted Approach to Rehabilitation for ConcussionIndividuals assigned to this treatment will receive in-person individual cognitive rehabilitation treatment conducted by credentialed speech or occupational therapists. Participants will complete up to three sessions per week (approximately 50 minutes each) for up to nine sessions plus one wrap up session. The treatment will include a focus on compensatory strategies and weekly homework assignments. Participants will work on personalized targets and assignments. The treatment will end with one wrap up session where participants will put together a plan for maintenance of what they have learned with their therapist's help. |
| Telehealth STAR-C | Other | Behavioral: Symptom-Targeted Approach to Rehabilitation for ConcussionIndividuals assigned to this treatment will receive individual cognitive rehabilitation treatment conducted by credentialed speech or occupational therapists via a telemedicine format. Participants will complete up to three sessions per week (approximately 50 minutes each) for up to nine sessions plus one wrap up session. The treatment will include a focus on compensatory strategies and weekly homework assignments. Participants will work on personalized targets and assignments. The treatment will end with one wrap up session where participants will put together a plan for maintenance of what they have learned with their therapist's help. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- mTBI defined per the VA/DoD Clinical Practice Guideline for the Management of Concussion-Mild Traumatic Brain Injury sustained in any context (deployment related or non-deployment-related) and at any time longer than 3 months previously.
- a score of 2, 3, or 4 on any of the four Cognitive items on the NSI, to include participants who have cognitive complaints.
- 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.
Key exclusion criteria (9 listed)
- History of a moderate, severe, or penetrating TBI as defined by DoD/VA guidelines.
- Lifetime diagnosis of schizophrenia or other psychotic/thought disorder.
- Current participation in intensive behavioral health treatment (≥3 appointments /encounters per week) for any psychiatric or substance use disorder.
- Current participation in other treatments that target cognition within the last two weeks (i.e., healthcare provider-prescribed cognitive rehabilitation in a group or individual format of any time duration or involving digital/game-based format of more than 4 hours per week).
- History of a neurological disease affecting cognitive function, other than mild TBI, such as multiple sclerosis, stroke, brain tumor, or Parkinson Disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptom-Targeted Approach to Rehabilitation for ConcussionThis study is looking at a shortened version of a therapist-direct cognitive rehabilitation intervention, known as STAR-C. STAR-C is focused on strategy use, and for strategy use to become a habit the person must have the opportunity for high-dose spaced practice. Thus, in STAR-C each session includes opportunities for repeated practice and participants schedule practice times between sessions. Sometimes a new strategy requires learning new facts, in which case the clinician chooses ingredients such as self-quizzing or comparing and contrasting outcomes, which are effective for learning new facts and concepts. | Behavioural | In-Person STAR-C, No Treatment Waitlist, Telehealth STAR-C |
Primary outcome
Common Concussive Cognitive Complaints (C4)
Time frame: From baseline to 3 months post treatment
On the C4, patients are asked to "identify challenges that are new since your injury and affect your everyday functioning, so we can focus therapy on what is most important to you." For each question, the patient is asked to choose the number that shows how often this has caused problems for them in everyday life in the past two weeks. Responses are on a scale from 1 (not at all) to 5 (all the time). The reliability and validity of the C4 are acceptable (internal consistency of domains: 0.465 to 0.797; 4-week test-retest reliability of domains: 0.628 to 0.832; convergent validity with MMPI-3 Cognitive Complaints and Inefficiency scales and discriminant validity with MMPI-3 Activation and Eating Concerns scales).
Goal Attainment Scaling (GAS)
Time frame: From treatment week 1 to 3 months post treatment
As described above in the Summary of ongoing relevant clinical trials, in each session, the patient and therapist collaborate to identify a desired outcome for the patient's target and then scale it using a 5-point rating system. The patient's current state relative to the target is assigned a 0 on the scale, achievement of the desired target is +2, partial achievement is +1, and achievement beyond expectations is +3. Success is defined as a GAS score of 2 or 3.
1 secondary outcome
Evaluate maintenance of treatment effects
Time frame: From baseline to 3 months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 17878767Cicerone KD, Azulay J. Perceived self-efficacy and life satisfaction after traumatic brain injury. J Head Trauma Rehabil. 2007 Sep-Oct;22(5):257-66. doi: 10.1097/01.HTR.0000290970.56130.81.
- Background: PubMed 18025964Corrigan JD, Bogner J. Initial reliability and validity of the Ohio State University TBI Identification Method. J Head Trauma Rehabil. 2007 Nov-Dec;22(6):318-29. doi: 10.1097/01.HTR.0000300227.67748.77.
- Background: PubMed 35968277Scheffler B, Schimbock F, Scholer A, Rosner K, Spallek J, Kopkow C. Tailored GuideLine Implementation in STrokE Rehabilitation (GLISTER) in Germany. Protocol of a Mixed Methods Study Using the Behavior Change Wheel and the Theoretical Domains Framework. Front Neurol. 2022 Jul 27;13:828521. doi: 10.3389/fneur.2022.828521. eCollection 2022.
- Background: PubMed 33422845Gromatsky M, Sullivan SR, Mitchell EL, Spears AP, Edwards ER, Goodman M. Feasibility and acceptability of VA CONNECT: Caring for our nation's needs electronically during the COVID-19 transition. Psychiatry Res. 2021 Feb;296:113700. doi: 10.1016/j.psychres.2020.113700. Epub 2020 Dec 31.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Background: PubMed 24135493Kendzerska TB, Smith PM, Brignardello-Petersen R, Leung RS, Tomlinson GA. Evaluation of the measurement properties of the Epworth sleepiness scale: a systematic review. Sleep Med Rev. 2014 Aug;18(4):321-31. doi: 10.1016/j.smrv.2013.08.002. Epub 2013 Aug 22.
- Background: PubMed 1798888Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
- Background: PubMed 10446661Kazis LE, Ren XS, Lee A, Skinner K, Rogers W, Clark J, Miller DR. Health status in VA patients: results from the Veterans Health Study. Am J Med Qual. 1999 Jan-Feb;14(1):28-38. doi: 10.1177/106286069901400105.
- Background: PubMed 26774513Beard C, Hsu KJ, Rifkin LS, Busch AB, Bjorgvinsson T. Validation of the PHQ-9 in a psychiatric sample. J Affect Disord. 2016 Mar 15;193:267-73. doi: 10.1016/j.jad.2015.12.075. Epub 2015 Dec 31.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 27321062Clapp JD, Kemp JJ, Cox KS, Tuerk PW. PATTERNS OF CHANGE IN RESPONSE TO PROLONGED EXPOSURE: IMPLICATIONS FOR TREATMENT OUTCOME. Depress Anxiety. 2016 Sep;33(9):807-15. doi: 10.1002/da.22534. Epub 2016 Jun 20.
- Background: PubMed 26751087Wortmann JH, Jordan AH, Weathers FW, Resick PA, Dondanville KA, Hall-Clark B, Foa EB, Young-McCaughan S, Yarvis JS, Hembree EA, Mintz J, Peterson AL, Litz BT. Psychometric analysis of the PTSD Checklist-5 (PCL-5) among treatment-seeking military service members. Psychol Assess. 2016 Nov;28(11):1392-1403. doi: 10.1037/pas0000260. Epub 2016 Jan 11.
- DOD TBI Worldwide NumbersLink provided by the sponsor.
- VA/DoD Clinical Practice Guideline for the Management and Rehabilitation of Post-Acute Mild Traumatic Brain InjuryLink provided by the sponsor.
- International Classification of Health Interventions (ICHI)Link provided by the sponsor.
- NIH Toolbox Cognition BatteryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Common Concussive Cognitive Complaints (C4); Goal Attainment Scaling (GAS); Audio recordings; Patient Characterization Measures (headache, sleep problems, dizziness, musculoskeletal injury and pain, medications, and use of commercial brain games); Neurobehavioral Symptom Inventory (NSI); Key Behaviors Change Inventory (KBCI); Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5); Patient Health Questionnaire (PHQ-9); Veterans RAND 36 Item Health Survey (VR-36); Epworth Sleepiness Scale (ESS); Feasibility of Intervention Measure (FIM)/Intervention Appropriateness Measure (IAM)/Acceptability of Intervention Measure (AIM); Self Efficacy for Symptom Management (SESx); NIH Toolbox - cognition; Memory Complaints Inventory (MCI); Inventory of Problems (IOP)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symptom-Targeted Approach to Rehabilitation for Concussion in people with Mild Traumatic Brain Injury (mTBI), run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Blaylock (210-916-8693, marc.j.blaylock.ctr@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Common Concussive Cognitive Complaints (C4) (time frame: From baseline to 3 months post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06855186, which also lists 58 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.