Brain ConcussionE-PSTNCT03759223
Enhanced Problem-Solving Training
A study testing Enhanced Problem-Solving Training (E-PST), Healthy Living Messages (HLM) and Enhanced Problem-Solving Training (E-PST) (non-randomized) 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) is among the most common injuries sustained by Veterans of Operations Enduring and Iraqi Freedom. It is also highly co-morbid with mental health conditions, such as post-traumatic stress disorder and depression. 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?
- Enhanced Problem-Solving Training (E-PST), Healthy Living Messages (HLM) and Enhanced Problem-Solving Training (E-PST) (non-randomized)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 7 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- OEF/OIF/OND Veteran
- history of mild Traumatic Brain Injury and persistent post-concussion-like symptoms of 3 months
- Brief Symptom Inventory-18 (BSI-18) T-score > 53
- enrolled in VA primary care (appointment within last 12 months)
- English speaking, able to read and write, and able to comprehend study materials
Who cannot join
- prior, current, or pending enrollment in a cognitive rehabilitation program or other specific TBI intervention program
- moderate to severe TBI or other major neurocognitive disorder
- psychotic disorder, e.g.: schizophrenia spectrum disorder, delusional disorder, schizotypal personality disorder, bipolar or depressive disorder with psychotic features
- acute suicidal ideation
- inpatient psychiatric hospitalization within the past 12 months
- any other illness or condition that would preclude or predictably influence ability to travel to, or engage in, study visits, as determined by the study team
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, 14215-1129
About this study
Official title: Enhanced Problem-Solving Training (E-PST) to Improve Recovery From mTBI
Mild traumatic brain injury (mTBI) is among the most common injuries sustained by Veterans of Operations Enduring and Iraqi Freedom. It is also highly co-morbid with mental health conditions, such as post-traumatic stress disorder and depression. While mTBI alone is not typically thought to cause lasting deficits in personal functioning or cognitive abilities, Veterans with a history of mTBI nonetheless report chronic psychological distress, as well as subjective difficulties with attention, concentration, poor frustration tolerance, and decision-making. Although current clinical practice guidelines for mTBI emphasize primary care-based symptom management, there are presently no evidence-based interventions to treat mental health symptoms in this setting. This research proposal therefore seeks to adapt and pilot test a brief, primary care-based intervention (E-PST) to reduce psychological distress in Veterans with mTBI by augmenting problem-solving skills, and helping them to develop specific cognitive and behavioral skills to improve upon their self-reported cognitive inefficiencies. The investigators hypothesize that Veterans who complete E-PST will report improvements in psychological distress compared to participants in the control condition.
Read the detailed description
Open Trial: The primary focus of the open trial is to gather feasibility and acceptability data from up to 12 participants, though clinical effect will also be evaluated using select measures outlined below. Feasibility metrics will be internally monitored. Participant feedback on the acceptability of E-PST will be gathered following each treatment session. Qualitative data will be analyzed using rapid qualitative analysis. Given the small sample, clinical effect will be descriptively explored. Individual line graphs of pre-post Brief Symptom Inventory-18 (BSI-18) scores will be generated, and mean differences in BSI-18 scores will be compared. Trends in change scores will be visually inspected to evaluate evidence of a preliminary clinical effect.
Randomized Trial: The focus of the randomized trial is threefold: a) to estimate a preliminary effect size for the primary outcome measure (BSI-18); b) determine the feasibility of the assessment plan; and c) establish feasibility of recruitment and retention in order to guide the design of a future multi-site efficacy trial. BSI-18 data will be described with means, standard deviations, and confidence intervals at each time point and condition. To show central tendency, variation and potential trends over time, means and 95% confidence intervals will be plotted across time for each condition. To assist in developing a larger trial, an effect size will be calculated at post-treatment to describe the standardized difference between conditions. All participants who are randomized and complete a baseline assessment will be included in our analysis. Evaluation of measurement feasibility will focus primarily on descriptive statistics (e.g., frequencies of missing/ incomplete measures). Recruitment and retention over the study duration will be plotted based on the number of participants enrolled into the study and compared to the anticipated rate of recruitment. Veteran feedback on the acceptability of E-PST and treatment satisfaction will be analyzed using rapid qualitative analysis.
- Conditions
- Brain Concussion
- Being tested
- Enhanced Problem-Solving Training (E-PST), Healthy Living Messages (HLM), Enhanced Problem-Solving Training (E-PST) (non-randomized)
- Keywords
- Mild Traumatic Brain Injury, Concussion, Mild, Veterans, Stress Disorders, Post-Traumatic
- Medical subject headings
- Brain Concussion, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Problem-Solving Training (E-PST)Behavioural
Also called Problem-Solving Training for Concussion (PST-Concussion)
E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages (HLM)Behavioural
Also called Control
Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care. Randomized participants were assigned 1:1 to E-PST or HLM.
Enhanced Problem-Solving Training (E-PST) (non-randomized)Behavioural
Also called Problem-Solving Training for Concussion (PST-Concussion)
E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. Non-randomized participants were assigned to E-PST only.
| Study group | Role | What they receive |
|---|---|---|
| E-PST (randomized) | Experimental | Enhanced Problem-Solving Training (E-PST) arm. E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. Randomized participants were assigned 1:1 to E-PST or HLM. Receives: Behavioral: Enhanced Problem-Solving Training (E-PST) |
| Control (randomized) | Active comparator | Healthy Living Messages (Control) arm. Healthy Living Messages (HLM) are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care. Randomized participants were assigned 1:1 to E-PST or HLM. Receives: Behavioral: Healthy Living Messages (HLM) |
| E-PST (non-randomized) | Other | Enhanced Problem-Solving Training (E-PST) arm. E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. Non-randomized participants were assigned to E-PST only. Receives: Behavioral: Enhanced Problem-Solving Training (E-PST) (non-randomized) |
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. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy, sex-matched individuals) with a standard deviation of 10. 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 (11)
Applied Cognition-General Concerns-Short Form (ACGC-8a)
An 8-item checklist of general cognitive concerns over the past week. Items were generated and validated as part of the National Institute of Health's Patient-Reported Outcome Measurement Information System (PROMIS). Raw scores are converted to T-scores (range = 23.3-62.7), with higher scores signaling relatively fewer cognitive concerns. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy individuals) with a standard deviation of 10.
Measured: Up to 24 weeks
Applied Cognition-Abilities-Short Form (ACA-8a)
An 8-item checklist of self-perceived cognitive abilities over the past week, developed as part of the National Institute of Health's Patient-Reported Outcome Measurement Information System (PROMIS). Raw scores are converted to T-scores (range = 27-64.8) with higher scores signaling higher perceived cognitive abilities. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy individuals) with a standard deviation of 10.
Measured: Up to 24 weeks
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. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy, age-matched individuals) with a standard deviation of 10.
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 scaled scores (range = 1-19) with corresponding percentile ranks (range = 1 to 99); higher scaled scores and percentile ranks signal better overall performance.
Measured: Up to 24 weeks
Patient Health Questionnaire-9 (PHQ-9)
A 9-item measure of cognitive, affective, and somatic depressive symptoms validated for use in primary care. Scores range from 0 to 27, with lower scores signaling lower mood symptoms.
Measured: Up to 24 weeks
PTSD Checklist for DSM-5 (PCL5)
A 20-item measure of DSM-5 symptoms related to trauma, organized over re-experiencing, avoidance, hyperarousal, and cognitive/mood domains. Score range from 0-80, with lower scores signaling less severe PTSD symptoms.
Measured: Up to 24 weeks
Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C)
A 3-item measure of the frequency and severity of alcohol intake over the past year. Scores range from 0 to 12, with lower scores signaling less overall alcohol consumption.
Measured: Up to 24 weeks
Brief Addictions Monitor-Revised (BAM-R)
A 17-item measure of substance misuse and associated functional impairment. The Use subscale score ranges from 0-12, with lower scores signaling no (0) or relatively lower substance use.
Measured: Up to 24 weeks
Pain Symptom Survey (PEG)
A 3-item pain assessment that has been validated for use in VA patients. Respondents are asked to report their average level of pain, the average impact of pain on their ability to enjoy life, and the average level of interference on daily activities on a scale of 0 to 10. Ratings on each domain are averaged to calculate a composite score, which ranges from 0 to 10, with lower scores signaling lower overall pain.
Measured: Up to 24 weeks
Patient Global Impressions of Change (PGIC)
A 7-point single-item rating scale that asks patients to rate their overall impression of response to treatment. Ratings range from "no change" to "a great deal better." Ratings range from 0 to 7, with higher ratings signaling greater perceived change in response to treatment. Because ratings are only collected after receiving a given treatment, baseline values are not collected.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Oct 2019
- Primary completion7 Jun 2023
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Up to 12 participants will first complete an open trial of E-PST to test the feasibility, acceptability, and preliminary clinical effect. Subsequently, up to 38 participants will be randomly assigned (1:1) to E-PST or a control condition comprised of supportive contact and symptom monitoring.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
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
- NCT03759223
- Sponsor's protocol ID
- D2796-W
- Other IDs
- RX002796
- Acronym
- E-PST
- Status last verified
- Aug 2024
- First submitted
- 28 Nov 2018
- Last updated
- 27 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Publications
King PR Jr, Beehler GP, Donnelly K, Funderburk JS, Wray LO. A Practical Guide to Applying the Delphi Technique in Mental Health Treatment Adaptation: The Example of Enhanced Problem-Solving Training (E-PST). Prof Psychol Res Pr. 2021 Aug;52(4):376-386. doi: 10.1037/pro0000371. Epub 2021 Jun 10.
PubMed 34446984King PR, Beehler GP, Donnelly K, Funderburk JS, Pengelly C, Wade M, Kretzmer T, Wray LO. Feasibility and acceptability of a brief intervention to improve mild traumatic brain injury recovery: Problem-solving training-concussion. Rehabil Psychol. 2023 May;68(2):135-145. doi: 10.1037/rep0000486. Epub 2023 Mar 9.
PubMed 36892882
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Problem-Solving Training (E-PST) to Improve Recovery From mTBI
- ClinicalTrials.gov ID
- NCT03759223
- Acronym / sponsor ID
- E-PST / D2796-W
- Conditions
- Brain Concussion
- Keywords
- Mild Traumatic Brain Injury, Concussion, Mild, Veterans, Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Posted 27 Aug 2024
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) is among the most common injuries sustained by Veterans of Operations Enduring and Iraqi Freedom. It is also highly co-morbid with mental health conditions, such as post-traumatic stress disorder and depression. While mTBI alone is not typically thought to cause lasting deficits in personal functioning or cognitive abilities, Veterans with a history of mTBI nonetheless report chronic psychological distress, as well as subjective difficulties with attention, concentration, poor frustration tolerance, and decision-making. Although current clinical practice guidelines for mTBI emphasize primary care-based symptom management, there are presently no evidence-based interventions to treat mental health symptoms in this setting. This research proposal therefore seeks to adapt and pilot test a brief, primary care-based intervention (E-PST) to reduce psychological distress in Veterans with mTBI by augmenting problem-solving skills, and helping them to develop specific cognitive and behavioral skills to improve upon their self-reported cognitive inefficiencies. The investigators hypothesize that Veterans who complete E-PST will report improvements in psychological distress compared to participants in the control condition.
Detailed description
Open Trial: The primary focus of the open trial is to gather feasibility and acceptability data from up to 12 participants, though clinical effect will also be evaluated using select measures outlined below. Feasibility metrics will be internally monitored. Participant feedback on the acceptability of E-PST will be gathered following each treatment session. Qualitative data will be analyzed using rapid qualitative analysis. Given the small sample, clinical effect will be descriptively explored. Individual line graphs of pre-post Brief Symptom Inventory-18 (BSI-18) scores will be generated, and mean differences in BSI-18 scores will be compared. Trends in change scores will be visually inspected to evaluate evidence of a preliminary clinical effect.
Randomized Trial: The focus of the randomized trial is threefold: a) to estimate a preliminary effect size for the primary outcome measure (BSI-18); b) determine the feasibility of the assessment plan; and c) establish feasibility of recruitment and retention in order to guide the design of a future multi-site efficacy trial. BSI-18 data will be described with means, standard deviations, and confidence intervals at each time point and condition. To show central tendency, variation and potential trends over time, means and 95% confidence intervals will be plotted across time for each condition. To assist in developing a larger trial, an effect size will be calculated at post-treatment to describe the standardized difference between conditions. All participants who are randomized and complete a baseline assessment will be included in our analysis. Evaluation of measurement feasibility will focus primarily on descriptive statistics (e.g., frequencies of missing/ incomplete measures). Recruitment and retention over the study duration will be plotted based on the number of participants enrolled into the study and compared to the anticipated rate of recruitment. Veteran feedback on the acceptability of E-PST and treatment satisfaction will be analyzed using rapid qualitative analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Up to 12 participants will first complete an open trial of E-PST to test the feasibility, acceptability, and preliminary clinical effect. Subsequently, up to 38 participants will be randomly assigned (1:1) to E-PST or a control condition comprised of supportive contact and symptom monitoring.
| Arm | Type | Receives |
|---|---|---|
| E-PST (randomized) | Experimental | Behavioral: Enhanced Problem-Solving Training (E-PST)Enhanced Problem-Solving Training (E-PST) arm. E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. Randomized participants were assigned 1:1 to E-PST or HLM. |
| Control (randomized) | Active comparator | Behavioral: Healthy Living Messages (HLM)Healthy Living Messages (Control) arm. Healthy Living Messages (HLM) are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care. Randomized participants were assigned 1:1 to E-PST or HLM. |
| E-PST (non-randomized) | Other | Behavioral: Enhanced Problem-Solving Training (E-PST) (non-randomized)Enhanced Problem-Solving Training (E-PST) arm. E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. Non-randomized participants were assigned to E-PST only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- OEF/OIF/OND Veteran
- history of mild Traumatic Brain Injury and persistent post-concussion-like symptoms of 3 months
- Brief Symptom Inventory-18 (BSI-18) T-score > 53
- enrolled in VA primary care (appointment within last 12 months)
- English speaking, able to read and write, and able to comprehend study materials
Key exclusion criteria (6 listed)
- prior, current, or pending enrollment in a cognitive rehabilitation program or other specific TBI intervention program
- moderate to severe TBI or other major neurocognitive disorder
- psychotic disorder, e.g.: schizophrenia spectrum disorder, delusional disorder, schizotypal personality disorder, bipolar or depressive disorder with psychotic features
- acute suicidal ideation
- inpatient psychiatric hospitalization within the past 12 months
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 |
|---|---|---|
| Enhanced Problem-Solving Training (E-PST)Also: Problem-Solving Training for Concussion (PST-Concussion)E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. Randomized participants were assigned 1:1 to E-PST or HLM. | Behavioural | E-PST (randomized) |
| Healthy Living Messages (HLM)Also: ControlHealthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care. Randomized participants were assigned 1:1 to E-PST or HLM. | Behavioural | Control (randomized) |
| Enhanced Problem-Solving Training (E-PST) (non-randomized)Also: Problem-Solving Training for Concussion (PST-Concussion)E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. Non-randomized participants were assigned to E-PST only. | Behavioural | E-PST (non-randomized) |
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. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy, sex-matched individuals) with a standard deviation of 10. GSI T-scores range from 30-80, with lower scores signaling an overall lower level of psychological distress.
11 secondary outcomes
Applied Cognition-General Concerns-Short Form (ACGC-8a)
Time frame: Up to 24 weeks
Applied Cognition-Abilities-Short Form (ACA-8a)
Time frame: Up to 24 weeks
Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: Up to 24 weeks
Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span
Time frame: Up to 24 weeks
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Up to 24 weeks
PTSD Checklist for DSM-5 (PCL5)
Time frame: Up to 24 weeks
Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C)
Time frame: Up to 24 weeks
Brief Addictions Monitor-Revised (BAM-R)
Time frame: Up to 24 weeks
Pain Symptom Survey (PEG)
Time frame: Up to 24 weeks
Patient Global Impressions of Change (PGIC)
Time frame: Up to 24 weeks
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Time frame: Up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34446984King PR Jr, Beehler GP, Donnelly K, Funderburk JS, Wray LO. A Practical Guide to Applying the Delphi Technique in Mental Health Treatment Adaptation: The Example of Enhanced Problem-Solving Training (E-PST). Prof Psychol Res Pr. 2021 Aug;52(4):376-386. doi: 10.1037/pro0000371. Epub 2021 Jun 10.
- Background: PubMed 36892882King PR, Beehler GP, Donnelly K, Funderburk JS, Pengelly C, Wade M, Kretzmer T, Wray LO. Feasibility and acceptability of a brief intervention to improve mild traumatic brain injury recovery: Problem-solving training-concussion. Rehabil Psychol. 2023 May;68(2):135-145. doi: 10.1037/rep0000486. Epub 2023 Mar 9.
- 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. This study is not recruiting at the moment.
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 Enhanced Problem-Solving Training (E-PST), Healthy Living Messages (HLM) and Enhanced Problem-Solving Training (E-PST) (non-randomized) 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 5 inclusion and 6 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 27 Aug 2024. 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?
Yes. Results are posted in the registry (first posted 27 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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?
On the ClinicalTrials.gov record for NCT03759223, which also lists 2 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 27 Aug 2024.