Concussion, MildNCT05849064
Concussion Treatment in Older Adults
A study testing Targeted Intervention in people with Concussion, Mild, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to conduct the first randomized control trial for targeted treatments for concussion in adults 50 years or older. Participants will be enrolled at their first concussion clinical visit (V1) and their second study visit will occur after (up to 7 days) or concurrently with the participant's… Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Concussion, Mild
- What is being tested?
- Targeted Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2023to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years of age or older
- Diagnosed concussion within the last 4 days - 12 months
- Must be recruited at their initial concussion appointment
- Ability to read/write to complete study assessments/testing
Who cannot join
- Diagnosed major psychiatric disorders other than depression/anxiety (e.g., schizophrenia)
- Diagnosed with moderate to severe brain injury or past brain surgery/malformations
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15203
About this study
Official title: Randomized Controlled Trial of Targeted Treatment in Older Adults Following Concussion
The purpose of this study is to conduct the first randomized control trial for targeted treatments for concussion in adults 50 years or older. Participants will be enrolled at their first concussion clinical visit (V1) and their second study visit will occur after (up to 7 days) or concurrently with the participant's second concussion clinical visit, typically (but not limited to) between 21-31 days from V1.
Read the detailed description
Although concussion is a common occurrence in older adults, we know little about the injury in this at-risk population. Certain management tools that might be appropriate for adolescent and young adult populations may not be appropriate for use in older adults who may have sensory, cognitive, and neuro-motor limitations. This study will help to develop initial evidence for targeted treatments for concussion in older adults. The study will utilize a two group design with permuted block random assignment to intervention and usual care/control groups. All participants will complete the following assessments at their initial and follow-up visit appointments: cognitive screening (learning, memory, language, executive functioning), concussion and mood symptom questionnaires, and neuro-motor screening. The primary outcomes for this study will be total symptom severity score (i.e., symptom burden) on the Concussion Clinical Profiles Screening (CP Screen) and Patient Global Impression of Change (PGIC). Secondary outcomes will include: Short Falls Efficacy Scale (SFES), Dizziness Handicap Inventory (DHI), Patient Health Questionnaire-9 (PHQ-9), Patient Health Questionnaire-15 (PHQ-15), Generalized Anxiety Disorder - 7 (GAD-7), Posttraumatic Stress Disorder Checklist (PCL-5), Pittsburgh Sleep Quality Index (PSQI), Neuro-Quality of Life (QOL) v2.0 - Cognition Function (Short version), Headache Impact Test (HIT-6), ID Migraine, Neck Disability Index (NDI), Vestibular Ocular Motor Screen (VOMS), Timed-Up-and-Go (TUG), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). All outcomes will be treated as continuous.
- Conditions
- Concussion, Mild
- Being tested
- Behavioral Control, Targeted Intervention
- Keywords
- concussion, mild traumatic brain injury, treatment, older adults
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ControlBehavioural
Participants will receive standardized behavioral management strategies for their concussion symptoms including: activity, hydration, nutrition, sleep, and stress management strategies. These strategies provide general methods to manage concussion symptoms and regulate daily activities to assist in the recovery of concussion.
Targeted InterventionBehavioural
Participants will be prescribed one or more interventions, tailored to their domains. Anxiety/Mood-Cog beh therapy(CBT) for maladaptive beliefs/avoidance/coping behaviors. Graded exposure/activity/relaxation exercises, cognitive restructuring. Cognitive-Accommodations for reduced work/school time/delayed deadlines, more frequent/longer cognitive rest during symptom-provoking activities. Migraine/Headache: Education, relaxation training/mindfulness based therapy. Ocular-Exercises for ocular symptoms, near point convergence, may include Brock string, pencil push-ups, fixation, saccade tracking, pursuits. Sleep-Sleep regulation/hygiene. Mindfulness-based training, morning physical activity, CBT.Vestibular-Exercises for dizziness, visual motion sensitivity, gait, imbalance that may include gaze stability, visual habituation, static and dynamic balance/gait.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Control | Active comparator | Participants randomized to the behavioral control group will receive standardized (i.e., all participants in this group will receive the same interventions) behavioral management strategies that include activity, hydration, nutrition, sleep, and stress management strategies. Receives: Behavioral: Behavioral Control |
| Targeted Intervention | Experimental | Participant receives exercises or strategies based on their clinical concussion domain given to them by their neuropsychologist: 1) Anxiety/Mood, 2)Headache/Migraine, 3)Vestibular, 4)Ocular, 5)Cognitive. Receives: Behavioral: Targeted Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concussion Clinical Profiles Screening (CP Screen)
The CP Screen is a 29 item self-report, clinical profiles based symptom inventory that measures five concussion clinical profiles: 1) anxiety/mood, 2)cognitive/fatigue, 3) migraine, 4) ocular, 5) vestibular; and two modifying factors sleep and cervical. Participants indicate on a scale of 0 (none) to 3 (severe) the level of symptom severity for each item. The CP screen yields an average factor and modifier scores, with higher scores indicative of worse symptom severity, score range is 0-87.
Measured: Visit 1 (Baseline)
Concussion Clinical Profiles Screening (CP Screen)
The CP Screen is a 29 item self-report, clinical profiles based symptom inventory that measures five concussion clinical profiles: 1) anxiety/mood, 2)cognitive/fatigue, 3) migraine, 4) ocular, 5) vestibular; and two modifying factors sleep and cervical. Participants indicate on a scale of 0 (none) to 3 (severe) the level of symptom severity for each item. The CP screen yields an average factor and modifier scores, with higher scores indicative of worse symptom severity, score range is 0-87.
Measured: At study completion, an average of 30 days after Visit 1
Secondary outcomes (30)
Vestibular/Ocular Motor Screening (VOMS)
The VOMS assesses impairment via patient report symptom provocation following each of 5 test components (smooth pursuits, horizontal/vertical saccades, convergence, horizontal and vertical vestibular ocular reflex (VOR) and visual motor sensitivity (VMS). Patients verbally rate changes in headache, dizziness, nausea, and fogginess after each test, as well as report their baseline symptoms. Symptoms in each area are rated on scale 0 (none) to 10 (severe). Scores on any VOMS item of 2+ reflects a positive screening cut-off for vestibular and/or ocular motor impairment.
Measured: Visit 1 (Baseline)
Vestibular/Ocular Motor Screening (VOMS)
The VOMS assesses impairment via patient report symptom provocation following each of 5 test components (smooth pursuits, horizontal/vertical saccades, convergence, horizontal and vertical vestibular ocular reflex (VOR) and visual motor sensitivity (VMS). Patients verbally rate changes in headache, dizziness, nausea, and fogginess after each test, as well as report their baseline symptoms. Symptoms in each area are rated on scale 0 (none) to 10 (severe). Scores on any VOMS item of 2+ reflects a positive screening cut-off for vestibular and/or ocular motor impairment.
Measured: At study completion, an average of 30 days after Visit 1
Short Falls Efficacy Scale (SFES)
The SFES is a 7 item survey that measures a subject's fear and concerns about falling during normal daily life activities. Question responses are scaled from 1-4, with higher scores indicating more concern for falls. (Low concern = 7-8; Moderate concern = 9-13; High concern = 14-28).
Measured: Visit 1 (Baseline)
Short Falls Efficacy Scale (SFES)
The SFES is a 7 item survey that measures a subject's fear and concerns about falling during normal daily life activities. Question responses are scaled from 1-4, with higher scores indicating more concern for falls. (Low concern = 7-8; Moderate concern = 9-13; High concern = 14-28).
Measured: At study completion, an average of 30 days after Visit 1
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a 9 item questionnaire that assesses the presence and severity of depression. Total score ranges from 1-27, with higher scores indicating higher level of depression. Scale is 0-4 (0=not at all, 1=several days, 2=more than half the days, 3=nearly every day).
Measured: Visit 1 (Baseline)
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a 9 item questionnaire that assesses the presence and severity of depression. The PHQ-9 is a 9 item questionnaire that assesses the presence and severity of depression. Total score ranges from 1-27, with higher scores indicating higher level of depression. Scale is 0-4 (0=not at all, 1=several days, 2=more than half the days, 3=nearly every day).
Measured: At study completion, an average of 30 days after Visit 1
Patient Health Questionnaire-15 (PHQ-15)
The PHQ-15 comprises 15 somatic symptoms that are scored from 0 ("not bothered at all") to 2 ("bothered a lot"). Higher scores are indicative of higher levels of depression (Minimal =0-4; Low = 5-9; Medium = 10-14; High = 15=30).
Measured: Visit 1 (Baseline)
Patient Health Questionnaire-15 (PHQ-15)
The PHQ-15 comprises 15 somatic symptoms that are scored from 0 ("not bothered at all") to 2 ("bothered a lot"). Higher scores are indicative of higher levels of depression (Minimal =0-4; Low = 5-9; Medium = 10-14; High = 15=30).
Measured: At study completion, an average of 30 days after Visit 1
General Anxiety Disorder-7 (GAD-7)
The GAD-7 is a seven item self-reported questionnaire that measures severity of symptoms regarding anxiety. Responses are 0 = not at all, 1 = several days, 2= more than half the days, and 3 = nearly every day. Higher scores are indicative of higher anxiety (0-4 = minimal anxiety, 5-9= mild anxiety, 10-14 =moderate anxiety, 15-21 = severe anxiety.
Measured: Visit 1 (Baseline)
General Anxiety Disorder-7 (GAD-7)
The GAD-7 is a seven item self-reported questionnaire that measures severity of symptoms regarding anxiety. Responses are 0 = not at all, 1 = several days, 2= more than half the days, and 3 = nearly every day. Higher scores are indicative of higher anxiety (0-4 = minimal anxiety, 5-9= mild anxiety, 10-14 =moderate anxiety, 15-21 = severe anxiety.
Measured: At study completion, an average of 30 days after Visit 1
PCL-5
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Responses are on a 5 point likert scale (0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, 4=extremely). Overall score is total sum of 20 items with higher scores indicating higher level of PTSD (Range 0-80)
Measured: Visit 1 (Baseline)
PCL-5
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Responses are on a 5 point likert scale (0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, 4=extremely). Overall score is total sum of 20 items with higher scores indicating higher level of PTSD (Range 0-80).
Measured: At study completion, an average of 30 days after Visit 1
Neuro-QOL (Cognitive Function Scale - short form)
The cognitive function measures perceived difficulties in cognitive abilities (e.g., memory, attention, and decision making, or in the application of such abilities to everyday tasks (e.g., planning, organizing, calculating, remembering and learning). The short form contains 8 items, scored 0-5 (5=never, 4=rarely/once, 3=sometimes/2-3 times, 2=often/once a day, 1=very often/several times per day. Total scores range from 0-40. Higher scores indicate better self-reported cognitive function.
Measured: Visit 1 (Baseline)
Neuro-QOL (Cognitive Function Scale - short form)
The cognitive function measures perceived difficulties in cognitive abilities (e.g., memory, attention, and decision making, or in the application of such abilities to everyday tasks (e.g., planning, organizing, calculating, remembering and learning). The short form contains 8 items, scored 0-5 (5=never, 4=rarely/once, 3=sometimes/2-3 times, 2=often/once a day, 1=very often/several times per day. Total scores range from 0-40. Higher scores indicate better self-reported cognitive function.
Measured: At study completion, an average of 30 days after Visit 1
Dizziness Handicap Inventory (DHI)
The DHI is a 25 item self-reported measure that examines dizziness-related handicap. The assessment has 3 domains (functional, emotional, and physical). Participants self-report the level dizziness has impacted their abilities in the 3 domains with each domain having 9 questions (questions are answered No (0)/Sometimes(2)/Yes(4)) Item scores are summed. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional). Minimum score is 0.
Measured: Visit 1 (Baseline)
Dizziness Handicap Inventory (DHI)
The DHI is a 25 item self-reported measure that examines dizziness-related handicap. The assessment has 3 domains (functional, emotional, and physical). Participants self-report the level dizziness has impacted their abilities in the 3 domains with each domain having 9 questions (questions are answered No (0)/Sometimes(2)/Yes(4)) Item scores are summed. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional). Minimum score is 0.
Measured: At study completion, an average of 30 days after Visit 1
Headache Impact Test-6 (HIT-6)
The HIT-6 is comprised of 6 self-report items that assess frequency, severity and limitations of daily activities, fatigue, irritability, and concentration related to headaches. Items score from 6 to 13, with higher scores indicating worse severity. Scores = never = 6pts, rarely = 8 pts, sometimes = 10pts, very often = 11 pts, always = 13 points. Score range 36-78.
Measured: Visit 1 (Baseline)
Headache Impact Test-6 (HIT-6)
The HIT-6 is comprised of 6 self-report items that assess frequency, severity and limitations of daily activities, fatigue, irritability, and concentration related to headaches. Items score from 6 to 13, with higher scores indicating worse severity. Scores = never = 6pts, rarely = 8 pts, sometimes = 10pts, very often = 11 pts, always = 13 points. Score range 36-78.
Measured: At study completion, an average of 30 days after Visit 1
ID Migraine
The ID Migraine will be used to screen for headache symptoms. It is a 3 item screening tool designed to assess presence (yes/no) of symptoms related to headache/migraine pain. Scores range from 0-3 with clinical cut-off of 2+ indicating presence of migraines.
Measured: Visit 1 (Baseline)
ID Migraine
The ID Migraine will be used to screen for headache symptoms. It is a 3 item screening tool designed to assess presence (yes/no) of symptoms related to headache/migraine pain. Scores range from 0-3 with clinical cut-off of 2+ indicating presence of migraines.
Measured: At study completion, an average of 30 days after Visit 1
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
RBANS provides a brief, individually administered battery to measure cognitive decline or improvement across 5 domains (Immediate memory, visuospatial/constructional, language, attention, and delayed memory. There are total scores and indices scores, which are different depending on age and gender. Higher scores indicate better performance for all 5 domains. (<69=extremely low, 70-79=borderline, 80-89-low average, 90-109=average, 110-119=high average, 120-129=superior, 130 and higher = very superior).
Measured: Visit 1 (Baseline)
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
RBANS provides a brief, individually administered battery to measure cognitive decline or improvement across 5 domains (Immediate memory, visuospatial/constructional, language, attention, and delayed memory. There are total scores and indices scores, which are different depending on age and gender. Higher scores indicate better performance for all 5 domains. (<69=extremely low, 70-79=borderline, 80-89-low average, 90-109=average, 110-119=high average, 120-129=superior, 130 and higher = very superior).
Measured: At study completion, an average of 30 days after Visit 1
Neck Disability Index
Neck pain scale, each item scores 0-5 with range 0-50. Overall score out of 50 is multiplied by 100 to get a percentage. 0-20% = minimal disability, 20-40% is moderate disability, 40-60% severe disability, 60-80% = crippled, 80-100% =participants are either bed-bound or exaggerating symptoms.
Measured: Visit 1 (Baseline)
Neck Disability Index
Neck pain scale, each item scores 0-5 with range 0-50. Overall score out of 50 is multiplied by 100 to get a percentage. 0-20% = minimal disability, 20-40% is moderate disability, 40-60% severe disability, 60-80% = crippled, 80-100% =participants are either bed-bound or exaggerating symptoms.
Measured: At study completion, an average of 30 days after Visit 1
Pittsburgh Sleep Quality Index (PSQI)
The PSQI assesses sleep quality. It is an 19 item self-reported measure that is comprised of seven component scores: 1) subjective sleep quality, 2) sleep latency, 3) sleep duration, 4) sleep efficiency, 5) sleep disturbances, 6) sleep medication usage, and 7) daytime dysfunction. Each item is scored 0-3 (0 = very good, 1 = fairly good, 2= fairly bad, 3=very bad). Higher scores indicate more sleep dysfunction. Score range is 0-21.
Measured: Visit 1 (Baseline)
Pittsburgh Sleep Quality Index (PSQI)
The PSQI assesses sleep quality. It is an 19 item self-reported measure that is comprised of seven component scores: 1) subjective sleep quality, 2) sleep latency, 3) sleep duration, 4) sleep efficiency, 5) sleep disturbances, 6) sleep medication usage, and 7) daytime dysfunction. Each item is scored 0-3 (0 = very good, 1 = fairly good, 2= fairly bad, 3=very bad). Higher scores indicate more sleep dysfunction. Score range is 0-21.
Measured: At study completion, an average of 30 days after Visit 1
Timed-Up-and-Go
Walking balance test, distance of 3 meters (10 feet). Participants are timed. Participants are seated in a chair, instructed to get up, walk 3 meters (marked on floor or by cone), round the cone, return to the chair and sit back down. Participants will repeat this 3 times, and we will use the average time. < 10 second = normal, <20 seconds, good mobility, <30 second, problems/may require aid. Higher scores indicating more problems with mobility.
Measured: Visit 1 (Baseline)
Timed-Up-and-Go
Walking balance test, distance of 3 meters (10 feet). Participants are timed. Participants are seated in a chair, instructed to get up, walk 3 meters (marked on floor or by cone), round the cone, return to the chair and sit back down. Participants will repeat this 3 times, and we will use the average time. < 10 second = normal, <20 seconds, good mobility, <30 second, problems/may require aid. Higher scores indicating more problems with mobility.
Measured: At study completion, an average of 30 days after Visit 1
Patient's Global Impression of Change (PGIC)
PGIC is a self-reported assessment of change. Participants rate their impression of how much better they feel on a 7 point likert scale. It is a 1 item survey, with higher scores representing no change and associated with feeling worse. (Responses 1=much improved, 2=minimally improved, 3=no change, 4=minimally worse, 5=much worse, 6=very much worse).
Measured: Daily between Visit 1 and study completion, an average of 30 days
Percent Back to Normal
Subject rates on a scale from 0% to 100% how much they feel like they are back to normal (before injury)
Measured: Daily between Visit 1 and study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start7 Sep 2023
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Model description
- One group receives basic behavioral management strategies. The second group gets targeted treatment strategies dependent on the concussion symptoms they are expressing.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony P. Kontos, Ph.D., University of Pittsburgh
- Investigators
- Anthony Kontos, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849064
- Sponsor's protocol ID
- STUDY23020055
- Status last verified
- Aug 2026
- First submitted
- 13 Apr 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Targeted Treatment in Older Adults Following Concussion
- ClinicalTrials.gov ID
- NCT05849064
- Acronym / sponsor ID
- STUDY23020055
- Conditions
- Concussion, Mild
- Keywords
- concussion, mild traumatic brain injury, treatment, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 8 May 2023 (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.
The purpose of this study is to conduct the first randomized control trial for targeted treatments for concussion in adults 50 years or older. Participants will be enrolled at their first concussion clinical visit (V1) and their second study visit will occur after (up to 7 days) or concurrently with the participant's second concussion clinical visit, typically (but not limited to) between 21-31 days from V1.
Detailed description
Although concussion is a common occurrence in older adults, we know little about the injury in this at-risk population. Certain management tools that might be appropriate for adolescent and young adult populations may not be appropriate for use in older adults who may have sensory, cognitive, and neuro-motor limitations. This study will help to develop initial evidence for targeted treatments for concussion in older adults. The study will utilize a two group design with permuted block random assignment to intervention and usual care/control groups. All participants will complete the following assessments at their initial and follow-up visit appointments: cognitive screening (learning, memory, language, executive functioning), concussion and mood symptom questionnaires, and neuro-motor screening. The primary outcomes for this study will be total symptom severity score (i.e., symptom burden) on the Concussion Clinical Profiles Screening (CP Screen) and Patient Global Impression of Change (PGIC). Secondary outcomes will include: Short Falls Efficacy Scale (SFES), Dizziness Handicap Inventory (DHI), Patient Health Questionnaire-9 (PHQ-9), Patient Health Questionnaire-15 (PHQ-15), Generalized Anxiety Disorder - 7 (GAD-7), Posttraumatic Stress Disorder Checklist (PCL-5), Pittsburgh Sleep Quality Index (PSQI), Neuro-Quality of Life (QOL) v2.0 - Cognition Function (Short version), Headache Impact Test (HIT-6), ID Migraine, Neck Disability Index (NDI), Vestibular Ocular Motor Screen (VOMS), Timed-Up-and-Go (TUG), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). All outcomes will be treated as continuous.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- One group receives basic behavioral management strategies. The second group gets targeted treatment strategies dependent on the concussion symptoms they are expressing.
| Arm | Type | Receives |
|---|---|---|
| Behavioral Control | Active comparator | Behavioral: Behavioral ControlParticipants randomized to the behavioral control group will receive standardized (i.e., all participants in this group will receive the same interventions) behavioral management strategies that include activity, hydration, nutrition, sleep, and stress management strategies. |
| Targeted Intervention | Experimental | Behavioral: Targeted InterventionParticipant receives exercises or strategies based on their clinical concussion domain given to them by their neuropsychologist: 1) Anxiety/Mood, 2)Headache/Migraine, 3)Vestibular, 4)Ocular, 5)Cognitive. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 50 years of age or older
- Diagnosed concussion within the last 4 days - 12 months
- Must be recruited at their initial concussion appointment
- Ability to read/write to complete study assessments/testing
Key exclusion criteria (2 listed)
- Diagnosed major psychiatric disorders other than depression/anxiety (e.g., schizophrenia)
- Diagnosed with moderate to severe brain injury or past brain surgery/malformations
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 |
|---|---|---|
| Behavioral ControlParticipants will receive standardized behavioral management strategies for their concussion symptoms including: activity, hydration, nutrition, sleep, and stress management strategies. These strategies provide general methods to manage concussion symptoms and regulate daily activities to assist in the recovery of concussion. | Behavioural | Behavioral Control |
| Targeted InterventionParticipants will be prescribed one or more interventions, tailored to their domains. Anxiety/Mood-Cog beh therapy(CBT) for maladaptive beliefs/avoidance/coping behaviors. Graded exposure/activity/relaxation exercises, cognitive restructuring. Cognitive-Accommodations for reduced work/school time/delayed deadlines, more frequent/longer cognitive rest during symptom-provoking activities. Migraine/Headache: Education, relaxation training/mindfulness based therapy. Ocular-Exercises for ocular symptoms, near point convergence, may include Brock string, pencil push-ups, fixation, saccade tracking, pursuits. Sleep-Sleep regulation/hygiene. Mindfulness-based training, morning physical activity, CBT.Vestibular-Exercises for dizziness, visual motion sensitivity, gait, imbalance that may include gaze stability, visual habituation, static and dynamic balance/gait. | Behavioural | Targeted Intervention |
Primary outcome
Concussion Clinical Profiles Screening (CP Screen)
Time frame: Visit 1 (Baseline)
The CP Screen is a 29 item self-report, clinical profiles based symptom inventory that measures five concussion clinical profiles: 1) anxiety/mood, 2)cognitive/fatigue, 3) migraine, 4) ocular, 5) vestibular; and two modifying factors sleep and cervical. Participants indicate on a scale of 0 (none) to 3 (severe) the level of symptom severity for each item. The CP screen yields an average factor and modifier scores, with higher scores indicative of worse symptom severity, score range is 0-87.
Concussion Clinical Profiles Screening (CP Screen)
Time frame: At study completion, an average of 30 days after Visit 1
The CP Screen is a 29 item self-report, clinical profiles based symptom inventory that measures five concussion clinical profiles: 1) anxiety/mood, 2)cognitive/fatigue, 3) migraine, 4) ocular, 5) vestibular; and two modifying factors sleep and cervical. Participants indicate on a scale of 0 (none) to 3 (severe) the level of symptom severity for each item. The CP screen yields an average factor and modifier scores, with higher scores indicative of worse symptom severity, score range is 0-87.
30 secondary outcomes
Vestibular/Ocular Motor Screening (VOMS)
Time frame: Visit 1 (Baseline)
Vestibular/Ocular Motor Screening (VOMS)
Time frame: At study completion, an average of 30 days after Visit 1
Short Falls Efficacy Scale (SFES)
Time frame: Visit 1 (Baseline)
Short Falls Efficacy Scale (SFES)
Time frame: At study completion, an average of 30 days after Visit 1
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Visit 1 (Baseline)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: At study completion, an average of 30 days after Visit 1
Patient Health Questionnaire-15 (PHQ-15)
Time frame: Visit 1 (Baseline)
Patient Health Questionnaire-15 (PHQ-15)
Time frame: At study completion, an average of 30 days after Visit 1
General Anxiety Disorder-7 (GAD-7)
Time frame: Visit 1 (Baseline)
General Anxiety Disorder-7 (GAD-7)
Time frame: At study completion, an average of 30 days after Visit 1
PCL-5
Time frame: Visit 1 (Baseline)
PCL-5
Time frame: At study completion, an average of 30 days after Visit 1
Neuro-QOL (Cognitive Function Scale - short form)
Time frame: Visit 1 (Baseline)
Neuro-QOL (Cognitive Function Scale - short form)
Time frame: At study completion, an average of 30 days after Visit 1
Dizziness Handicap Inventory (DHI)
Time frame: Visit 1 (Baseline)
Dizziness Handicap Inventory (DHI)
Time frame: At study completion, an average of 30 days after Visit 1
Headache Impact Test-6 (HIT-6)
Time frame: Visit 1 (Baseline)
Headache Impact Test-6 (HIT-6)
Time frame: At study completion, an average of 30 days after Visit 1
ID Migraine
Time frame: Visit 1 (Baseline)
ID Migraine
Time frame: At study completion, an average of 30 days after Visit 1
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: Visit 1 (Baseline)
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: At study completion, an average of 30 days after Visit 1
Neck Disability Index
Time frame: Visit 1 (Baseline)
Neck Disability Index
Time frame: At study completion, an average of 30 days after Visit 1
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Visit 1 (Baseline)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: At study completion, an average of 30 days after Visit 1
Timed-Up-and-Go
Time frame: Visit 1 (Baseline)
Timed-Up-and-Go
Time frame: At study completion, an average of 30 days after Visit 1
Patient's Global Impression of Change (PGIC)
Time frame: Daily between Visit 1 and study completion, an average of 30 days
Percent Back to Normal
Time frame: Daily between Visit 1 and study completion, an average of 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Anthony Kontos, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Intervention in people with Concussion, Mild, run by University of Pittsburgh at 1 site 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concussion Clinical Profiles Screening (CP Screen) (time frame: Visit 1 (Baseline)). 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?
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 6 Aug 2026.