Brain ConcussionPST-ConcussionNCT05837676
Problem-Solving Training for Concussion
A study testing Problem Solving Training for Concussion and Treatment as usual in people with Brain Concussion, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Mild traumatic brain injury (mTBI), also known as concussion, is a common injury sustained by Veterans. While most individuals who sustain mTBI experience a complete recovery within several weeks of injury, many Veterans with history of mTBI report frequent and long-lasting neurobehavioral complaints and functional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Concussion
- What is being tested?
- Problem Solving Training for Concussion and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 30 Sep 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking Veteran enrolled in VHA care;
- History of concussion (mild traumatic brain injury or mTBI);
- Current psychological distress;
- Subjective neurocognitive symptoms of >= 3 months.
Who cannot join
- Moderate to severe TBI or other major neurocognitive disorder;
- Psychotic disorder (e.g., schizophrenia spectrum disorder, delusional disorder, bipolar or depressive disorder with psychotic features);
- Acute suicidal ideation;
- Inpatient psychiatric hospitalization within the past 12 months;
- Other illness/ condition that would preclude or predictably influence ability to engage in study visits, as determined by the study team.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, 14215-1129
Paul R King, PhD, 716-862-6038, paul.king2@va.gov
Paul R. King, PhD
About this study
Official title: Problem-Solving Training for Concussion (PST-Concussion): A Brief, Skills-Focused Intervention to Improve Functional Outcomes in Veterans With mTBI and Co-occurring Mental Health Symptoms
Mild traumatic brain injury (mTBI), also known as concussion, is a common injury sustained by Veterans. While most individuals who sustain mTBI experience a complete recovery within several weeks of injury, many Veterans with history of mTBI report frequent and long-lasting neurobehavioral complaints and functional impairment. Though research suggests that these outcomes are strongly influenced by co-occurring conditions such as post-traumatic stress disorder, depression, and chronic pain, evidence-based interventions capable of addressing this wide array of concerns are lacking. This study seeks to address this gap by evaluating the effectiveness of a brief and flexible behavioral health treatment (Problem-Solving Training for Concussion, or PST-Concussion), which was designed to be delivered by generalist providers working in VA primary care settings. If PST-Concussion is shown to be effective, this skills-focused intervention may help improve Veterans' recovery experience following mTBI.
Read the detailed description
This study will be a longitudinal randomized two-arm parallel group clinical trial. Participants will be randomized 1:1 to either PST-Concussion or treatment as usual (TAU). Participants assigned to PST-Concussion will receive six, approximately 30-minute telehealth treatment sessions. Assessments will include standard self-report and cognitive measures that will be administered at baseline, post-treatment, and three-month follow-up. The primary objective of this study will be to evaluate the effectiveness of PST-Concussion in reducing psychological distress compared to TAU. Secondary and tertiary objectives will be to evaluate whether PST-Concussion is associated with appreciable change in subjective neurocognitive functioning, objective neurocognitive functioning, psychosocial functioning, and disability and quality of life. Multi-level modeling will be used to evaluate treatment effects at post-treatment and three-month follow-up. A test of non-inferiority will be conducted to evaluate the potential durability of observed treatment effects from post-test to follow-up. A portion of participants assigned to PST-Concussion will also be interviewed at post-treatment or follow-up to gain insight into the practical impact of intervention on psychosocial functioning and quality of life.
- Conditions
- Brain Concussion
- Being tested
- Problem Solving Training for Concussion, Treatment as usual
- Keywords
- Mild Traumatic Brain Injury, Concussion, Mild, Veterans, Neurobehavioral Manifestations, Psychological Distress
- Medical subject headings
- Brain Concussion, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving Training for ConcussionBehavioural
Also called PST-Concussion
PST-Concussion is a combined treatment consisting of brief problem-solving training, standard concussion education, motivational interviewing, goal-setting, and compensatory cognitive strategies.
Treatment as usualOther
Also called TAU
Patients assigned to TAU will receive the care that they and their providers determine is necessary to best manage their presenting concerns.
| Study group | Role | What they receive |
|---|---|---|
| PST-Concussion | Experimental | Treatment arm. Six, approximately 30-minute telehealth treatment sessions comprised of brief problem-solving training, standard concussion education, motivational interviewing, goal-setting, and compensatory cognitive strategies. Receives: Behavioral: Problem Solving Training for Concussion |
| Treatment as usual (TAU) | Other | Control arm. Primary care treatment as usual. Patients assigned to TAU will receive the care that they and their providers determine is necessary to best manage their presenting concerns. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score
The BSI-18 is a brief measure of psychological distress brought about by common somatic and affective symptoms. It has been validated for use in patients with history of TBI and is appropriate for use in primary care. Similar to a previous trial of PST for mTBI, its Global Severity Index (GSI) T-score will serve as the primary outcome measure. GSI T-scores range from 30-80, with lower scores signaling an overall lower level of psychological distress.
Measured: Up to 24 weeks
Secondary outcomes (5)
Hopkins Verbal Learning Test-Revised (HVLT-R)
A brief test of verbal learning, recall, and recognition. Participants are read a word list over 3 learning trials, and are asked to recall as many words as possible after a 25-minute delay. Raw scores are converted to T-scores (range = <20 to >80), with higher scores signaling better verbal memory performance.
Measured: Up to 24 weeks
Neurobehavioral Symptom Inventory (NSI)
A 22-item checklist of affective, cognitive, and somatosensory symptoms commonly reported after concussion. Scores range from 0 to 88, with lower scores signaling lower overall symptom reports.
Measured: Up to 24 weeks
Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span
A brief verbal attention test. Participants are presented with a sequence of digits and asked to repeat them forward and backward. Raw scores are converted to percentile ranks (range = <1 to >99); higher ranks signal better overall performance.
Measured: Up to 24 weeks
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
A 26-item abbreviated version of the full-length WHOQOL measure that evaluates disability and quality of life in domains such as social relationships, physical and mental health, and satisfaction with person-environment interactions. Raw scores are averaged to compute domain scores (range = 4-20), with higher scores signaling an overall higher quality of life.
Measured: Up to 24 weeks
Inventory of Psychosocial Functioning (IPF)
An 80-item multidimensional measure of psychosocial functioning and impairment related to mental health symptoms. An overall total is calculated as the mean of all completed subscales, which include: romantic relationships, family, work, friendships and socializing, parenting, education, and self-care. Each domain scale yields a score ranging from 0-100, with higher scores indicating greater impairment.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Oct 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Participants will be randomized 1:1 to either PST-Concussion or treatment as usual (TAU).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul R. King, PhD, Principal investigator, VA Western New York Healthcare System, Buffalo, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837676
- Sponsor's protocol ID
- D4778-R
- Other IDs
- RX004778-01
- Acronym
- PST-Concussion
- Status last verified
- Sep 2025
- First submitted
- 19 Apr 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final data sets underlying all publications resulting from the proposed research will be shared outside VA. A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Problem-Solving Training for Concussion (PST-Concussion): A Brief, Skills-Focused Intervention to Improve Functional Outcomes in Veterans With mTBI and Co-occurring Mental Health Symptoms
- ClinicalTrials.gov ID
- NCT05837676
- Acronym / sponsor ID
- PST-Concussion / D4778-R
- Conditions
- Brain Concussion
- Keywords
- Mild Traumatic Brain Injury, Concussion, Mild, Veterans, Neurobehavioral Manifestations, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 1 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.
Mild traumatic brain injury (mTBI), also known as concussion, is a common injury sustained by Veterans. While most individuals who sustain mTBI experience a complete recovery within several weeks of injury, many Veterans with history of mTBI report frequent and long-lasting neurobehavioral complaints and functional impairment. Though research suggests that these outcomes are strongly influenced by co-occurring conditions such as post-traumatic stress disorder, depression, and chronic pain, evidence-based interventions capable of addressing this wide array of concerns are lacking. This study seeks to address this gap by evaluating the effectiveness of a brief and flexible behavioral health treatment (Problem-Solving Training for Concussion, or PST-Concussion), which was designed to be delivered by generalist providers working in VA primary care settings. If PST-Concussion is shown to be effective, this skills-focused intervention may help improve Veterans' recovery experience following mTBI.
Detailed description
This study will be a longitudinal randomized two-arm parallel group clinical trial. Participants will be randomized 1:1 to either PST-Concussion or treatment as usual (TAU). Participants assigned to PST-Concussion will receive six, approximately 30-minute telehealth treatment sessions. Assessments will include standard self-report and cognitive measures that will be administered at baseline, post-treatment, and three-month follow-up. The primary objective of this study will be to evaluate the effectiveness of PST-Concussion in reducing psychological distress compared to TAU. Secondary and tertiary objectives will be to evaluate whether PST-Concussion is associated with appreciable change in subjective neurocognitive functioning, objective neurocognitive functioning, psychosocial functioning, and disability and quality of life. Multi-level modeling will be used to evaluate treatment effects at post-treatment and three-month follow-up. A test of non-inferiority will be conducted to evaluate the potential durability of observed treatment effects from post-test to follow-up. A portion of participants assigned to PST-Concussion will also be interviewed at post-treatment or follow-up to gain insight into the practical impact of intervention on psychosocial functioning and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to either PST-Concussion or treatment as usual (TAU).
| Arm | Type | Receives |
|---|---|---|
| PST-Concussion | Experimental | Behavioral: Problem Solving Training for ConcussionTreatment arm. Six, approximately 30-minute telehealth treatment sessions comprised of brief problem-solving training, standard concussion education, motivational interviewing, goal-setting, and compensatory cognitive strategies. |
| Treatment as usual (TAU) | Other | Other: Treatment as usualControl arm. Primary care treatment as usual. Patients assigned to TAU will receive the care that they and their providers determine is necessary to best manage their presenting concerns. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English-speaking Veteran enrolled in VHA care;
- History of concussion (mild traumatic brain injury or mTBI);
- Current psychological distress;
- Subjective neurocognitive symptoms of >= 3 months.
Key exclusion criteria (5 listed)
- Moderate to severe TBI or other major neurocognitive disorder;
- Psychotic disorder (e.g., schizophrenia spectrum disorder, delusional disorder, bipolar or depressive disorder with psychotic features);
- Acute suicidal ideation;
- Inpatient psychiatric hospitalization within the past 12 months;
- Other illness/ condition that would preclude or predictably influence ability to engage in study visits, as determined by the study team.
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 |
|---|---|---|
| Problem Solving Training for ConcussionAlso: PST-ConcussionPST-Concussion is a combined treatment consisting of brief problem-solving training, standard concussion education, motivational interviewing, goal-setting, and compensatory cognitive strategies. | Behavioural | PST-Concussion |
| Treatment as usualAlso: TAUPatients assigned to TAU will receive the care that they and their providers determine is necessary to best manage their presenting concerns. | Other | Treatment as usual (TAU) |
Primary outcome
Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score
Time frame: Up to 24 weeks
The BSI-18 is a brief measure of psychological distress brought about by common somatic and affective symptoms. It has been validated for use in patients with history of TBI and is appropriate for use in primary care. Similar to a previous trial of PST for mTBI, its Global Severity Index (GSI) T-score will serve as the primary outcome measure. GSI T-scores range from 30-80, with lower scores signaling an overall lower level of psychological distress.
5 secondary outcomes
Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: Up to 24 weeks
Neurobehavioral Symptom Inventory (NSI)
Time frame: Up to 24 weeks
Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span
Time frame: Up to 24 weeks
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Time frame: Up to 24 weeks
Inventory of Psychosocial Functioning (IPF)
Time frame: Up to 24 weeks
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 Sep 2025.
- Individual participant dataSharing planned: Yes. Final data sets underlying all publications resulting from the proposed research will be shared outside VA. A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
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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.
Paul R. King, PhD principal investigator
VA Western New York Healthcare System, Buffalo, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving Training for Concussion and Treatment as usual in people with Brain Concussion, run by VA Office of Research and Development 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 5 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 Sep 2025. 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?
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 Paul R King, PhD ((716) 862-6038, paul.king2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score (time frame: Up to 24 weeks). 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 8 Sep 2025.