CLINICAL TRIAL

Enhanced Problem-Solving Training for Brain Concussion

Recruiting · 18+ · All Sexes · Buffalo, NY

This study is evaluating whether a brief intervention may help reduce psychological distress in veterans with mild traumatic brain injury.

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About the trial for Brain Concussion

Treatment Groups

This trial involves 2 different treatments. Enhanced Problem-Solving Training is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Enhanced Problem-Solving Training
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Healthy Living Messages
BEHAVIORAL

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
OEF/OIF/OND Veteran
Some people who have a mild traumatic brain injury (TBI) may continue to experience symptoms like headaches, dizziness, and trouble concentrating for up to three months after the injury. show original
Brief Symptom Inventory-18 (BSI-18) T-score > 53
Veterans enrolled in VA primary care (veterans who have seen a VA doctor in the last twelve months) are likely to have their health needs met. show original
I am an English speaker and can read and write show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 24 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 24 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 24 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Enhanced Problem-Solving Training will improve 1 primary outcome, 13 secondary outcomes, and 1 other outcome in patients with Brain Concussion. Measurement will happen over the course of Up to 24 weeks.

Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span
UP TO 24 WEEKS
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.
UP TO 24 WEEKS
Hopkins Verbal Learning Test-Revised (HVLT-R)
UP TO 24 WEEKS
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.
UP TO 24 WEEKS
Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C)
UP TO 24 WEEKS
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.
UP TO 24 WEEKS
Brief Addictions Monitor-Revised (BAM-R)
UP TO 24 WEEKS
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.
UP TO 24 WEEKS
Patient Global Impressions of Change (PGIC)
UP TO 24 WEEKS
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.
UP TO 24 WEEKS
Pain Symptom Survey (PEG)
UP TO 24 WEEKS
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.
UP TO 24 WEEKS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get brain concussion a year in the United States?

Concussions related to sports have increased in frequency and severity since the introduction of the National Basketball Association concussion rule in 2014. Concussions in other sports are also common, although the rate of related injury may exceed that seen in basketball concussions.

Anonymous Patient Answer

What are the signs of brain concussion?

The brain may be injured by the initial impact or the secondary brain injury. The initial injury may cause cognitive deficits, seizures, aphasia, and other signs of brain damage. The secondary injury may produce additional cognitive deficits and psychiatric symptoms, including dissociative episodes.

Anonymous Patient Answer

What causes brain concussion?

Brain concussion occurs at a high incidence. Older athletes appear more susceptible than younger athletes. Concussion in hockey may be associated with body checking, while repetitive concussions in American football may be aggravated by a head-first style of tackling.

Anonymous Patient Answer

Can brain concussion be cured?

Brain concussion, a life-threatening injuries commonly experienced by athletes, can be effectively treated. Recovery of consciousness can be achieved in most athletes with appropriate intervention.

Anonymous Patient Answer

What are common treatments for brain concussion?

Common treatments for patients with self-reported brain injuries include standard neurological assessments, physical therapy and a variety of medications and procedures. More recent treatments and devices include computer-based assessments and home exercise programs designed to improve recovery.

Anonymous Patient Answer

What is brain concussion?

Brain injuries are a growing concern. Brain injury can be the result of head trauma such as a blow to the head. Often, brain injuries are not seen until several weeks after the original event, and this delay can give us a lot to hide from our patients when it happens. It is important for medical doctors who do concussions to be aware about when to call for help, to assess every patient for concussions, and take full histories of each patient.

Anonymous Patient Answer

Does brain concussion run in families?

This report confirms that concussions run in families for both female and male athletes. Recent findings suggest that concussion risk can be reduced by understanding a parent' s concussion history as an example of a familial factor that increases the risk of concussions in the offspring.

Anonymous Patient Answer

Is enhanced problem-solving training safe for people?

[In this retrospective analysis, PSC seemed safe for subjects who had received PSC following concussion] (http://cdc.gov/ncidod/fede[ra](https://www.withpower.com/clinical-trials/ra)l/research/programs.html). Because PSC is based on the assumption that cognitive deficits are temporary, the results of this retrospective study suggest that PSC may be safe. However, a randomized, prospective study in a group of individuals with and without concussion is warranted.

Anonymous Patient Answer

Who should consider clinical trials for brain concussion?

The findings of this study suggest that considering trials for brain injury is more appropriate than considering concussion in a study sample as a whole because participants with brain injury were more likely to show clinically relevant recovery from their concussion. In a recent study, findings suggest that trials for brain injury may be needed to identify treatments that can halt or hasten recovery for brain injury patients in a more specific manner.

Anonymous Patient Answer

Is enhanced problem-solving training typically used in combination with any other treatments?

The combination of PST and cognitive therapy is effective at improving the symptomatology of postconcussive psychosis and may therefore be a good added tool when treating postconcussive psychosis.

Anonymous Patient Answer

What is the average age someone gets brain concussion?

The National Football League considers players to have a brain concussion if they show one of the following:\n1. at least two of four of these criteria were met.\nThe diagnosis of a concussion differs among three national sports governing bodies (NFL, US Olympic Committee, National Collegiate Athletic Association, NCAA). The NCAA and the NFL allow their players a post-game neurological exam to help diagnose and monitor concussion. One or even a few exams does not detect all traumatic brain injuries, and may detect only mild injuries which have long-term neurological complaints or impairment. The USOC also allows a players to be diagnosed if his helmet bottoms out or he's knocked unconscious. This allows the player to be taken out of the game.

Anonymous Patient Answer

How does enhanced problem-solving training work?

This article provides new information about an evidence-based treatment that may enhance outcomes in a diverse population of traumatic brain injury (TBI) patients. The PAST-C, an inpatient treatment facility, has been implementing a program to improve a patient's ability to engage in meaningful problem solving. These outcomes have been demonstrated in the behavioral assessments of the BAVQ. The PAST program incorporates the use of simulation training, a practice approach for improving knowledge and skills to the detriment of the patient. A number of studies have demonstrated the generalization of simulation training for treating cognitive difficulties associated with TBI. The use of simulation training in conjunction with conventional strategies may enhance the treatment outcomes for cognitive deficits, by improving general skills of the participants.

Anonymous Patient Answer
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