Problem-Solving Training for Concussion

(PST-Concussion Trial)

Overseen By Paul R King, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Moderate to severe TBI, Psychotic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

134 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help Veterans recover from mild traumatic brain injury (mTBI), commonly known as a concussion. The focus is on Problem-Solving Training for Concussion (PST-Concussion), which aims to ease long-lasting issues like mental distress and cognitive difficulties. Participants will either receive this special training or continue with their usual care. Veterans who have experienced a concussion, feel ongoing stress, and have noticed cognitive issues for at least three months might be a good fit for this study. As an unphased trial, this study offers Veterans a unique opportunity to contribute to innovative research that could improve recovery strategies for mTBI.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team to understand any specific requirements.

What prior data suggests that Problem-Solving Training for Concussion is safe?

Studies have shown that Problem-Solving Training (PST) for mild traumatic brain injury (mTBI) is generally safe for participants. Research, particularly with military service members, indicates it is well-tolerated. No major negative effects have been reported, meaning participants did not experience significant problems from the treatment. The program includes activities like problem-solving exercises and motivational interviewing, designed to be safe and non-invasive. This makes it a promising option for those dealing with the lasting effects of concussions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Problem Solving Training (PST) for concussion because it offers a fresh approach by combining telehealth technology with cognitive strategies. Unlike typical treatments that focus on rest and gradually returning to activities, PST actively engages patients in problem-solving exercises, motivational interviewing, and goal-setting. This method aims to empower patients by teaching them how to effectively manage their symptoms and daily challenges. By providing structured support remotely, PST could make concussion management more accessible and personalized, potentially enhancing recovery outcomes.

What evidence suggests that Problem-Solving Training for Concussion might be an effective treatment for mild traumatic brain injury?

Research shows that Problem-Solving Training for Concussion (PST-Concussion), which participants in this trial may receive, can aid recovery in people with mild traumatic brain injury (mTBI). Studies have found that similar problem-solving methods assist stroke recovery and benefit teenagers with brain injuries. This suggests that PST-Concussion could also support veterans with persistent symptoms after a concussion. Early results indicate that this treatment might reduce emotional distress and enhance overall recovery. Although more research is needed, these findings offer hope for those seeking effective concussion management. ^{1 2 4 6 7}

Who Is on the Research Team?

Paul R. King, PhD

Principal Investigator

VA Western New York Healthcare System, Buffalo, NY

Are You a Good Fit for This Trial?

This trial is for English-speaking Veterans enrolled in VHA care who have had a concussion and are experiencing ongoing psychological distress and cognitive symptoms for three months or more. It's not suitable for those with moderate to severe brain injuries, major neurocognitive disorders, psychotic disorders, recent suicidal thoughts, or recent psychiatric hospitalization.

Inclusion Criteria

I have had a concussion before.

English-speaking Veteran enrolled in VHA care

Current psychological distress

Exclusion Criteria

Acute suicidal ideation

Other illness/condition that would preclude or predictably influence ability to engage in study visits, as determined by the study team

I have a psychotic disorder such as schizophrenia or bipolar with psychosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six, approximately 30-minute telehealth treatment sessions of PST-Concussion

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person), 1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Problem Solving Training for Concussion

Trial Overview The study evaluates Problem-Solving Training (PST-Concussion), designed to help Veterans recover from mild traumatic brain injury by improving their coping skills. This treatment will be compared with the usual care provided to see if it can better address the complex issues faced after a concussion.

How Is the Trial Designed?

Group I: Treatment as usual (TAU) Experimental Treatment 1 Intervention

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.

Group II: PST-Concussion Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A randomized controlled trial involving adolescents aged 12 to 17 with traumatic brain injury showed that Counselor-Assisted Problem Solving (CAPS) significantly improved long-term functional outcomes compared to Internet resources only, particularly in child functioning.

The effectiveness of CAPS was especially pronounced in families with less-educated parents, suggesting that this online therapy could be a valuable resource for lower socioeconomic status families following a TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online problem-solving therapy after traumatic brain injury: a randomized controlled trial. Wade, SL., Kurowski, BG., Kirkwood, MW., et al.[2022]

In a study involving 107 older primary care patients, Problem Solving Therapy (PST) led to a resolution of 59% of the 568 problems identified, highlighting its effectiveness in addressing health-related issues.

Patients were 2.2 times more likely to resolve their own identified problems compared to those identified by healthcare professionals, suggesting that PST empowers patients to take charge of their health and wellness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered approach to building problem solving skills among older primary care patients: problems identified and resolved. Enguidanos, S., Coulourides Kogan, A., Keefe, B., et al.[2018]

In a pilot study involving 22 ischemic stroke survivors, problem-solving therapy (PST) showed clinically significant improvements in depressive symptoms compared to standard care, although these results were not statistically significant.

The study suggests that PST could be a beneficial intervention for stroke survivors during rehabilitation, indicating a need for further research and training for rehabilitation nurses in this therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Pilot Study of Problem-Solving Therapy for Stroke Survivors. Hadidi, NN., Lindquist, R., Buckwalter, K., et al.[2018]

The study found that delivering problem-solving training (PST) to care partners of individuals with traumatic brain injury, spinal cord injury, burn injury, or stroke during their hospital stay is feasible, with 41.4% of eligible participants consenting to the intervention.

Participants who completed the PST sessions reported high satisfaction and engagement, but barriers such as short hospital stays and lack of perceived benefit limited participation, indicating the need for strategies to enhance uptake and use of supportive tools like the smartphone app.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility Study of Problem-Solving Training for Care Partners of Adults With Traumatic Brain Injury, Spinal Cord Injury, Burn Injury, or Stroke During the Inpatient Hospital Stay. Juengst, SB., Osborne, CL., Holavanahalli, R., et al.[2023]

A review of five studies involving early educational interventions for concussion patients found limited evidence supporting their effectiveness in reducing postconcussion syndrome (PCS) symptoms, with only two studies showing significant improvements.

The studies varied widely in quality and methods, highlighting the need for standardized interventions and better-quality research to accurately assess the impact of educational information on PCS outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Early Educational Interventions in the Emergency Department to Reduce Incidence or Severity of Postconcussion Syndrome Following a Concussion: A Systematic Review. Eliyahu, L., Kirkland, S., Campbell, S., et al.[2022]

In a clinical trial involving 356 active duty service members with mild traumatic brain injury (mTBI), telephone-delivered problem-solving treatment (PST) significantly reduced psychological distress after 6 months compared to an education-only group, although these benefits did not last to the 12-month follow-up.

Participants reported a preference for PST over education-only interventions, and PST also led to short-term improvements in sleep, depression, PTSD symptoms, and physical functioning, suggesting it could be a valuable adjunct treatment for mTBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone Problem Solving for Service Members with Mild Traumatic Brain Injury: A Randomized, Clinical Trial. Bell, KR., Fann, JR., Brockway, JA., et al.[2022]

A randomized controlled trial involving 67 family caregivers of individuals with traumatic brain injuries showed that problem-solving training significantly reduced depression and health complaints over a year-long period.

While the training improved caregivers' dysfunctional problem-solving styles, it did not have a noticeable impact on their overall well-being or perceived burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem-solving training for family caregivers of persons with traumatic brain injuries: a randomized controlled trial. Rivera, PA., Elliott, TR., Berry, JW., et al.[2021]

In a pilot study involving 34 participants with a history of suicide attempts or depression, Problem Solving Training (PST) significantly reduced levels of depression and hopelessness after eight weeks of therapy.

PST also improved participants' problem-solving skills and goal orientation, suggesting it is an effective method for suicide prevention in both outpatient and inpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[An effective method of therapy in suicide prevention: problem solving training in the clinical population]. Ajtay, G., Bérdi, M., Szilágyi, S., et al.[2022]

In a study of active duty service members with mild traumatic brain injury, those receiving telephone-based problem-solving treatment (PST) had significantly higher odds (6.17 times) of visiting the emergency department or being hospitalized compared to those who received only educational materials, although this finding was not statistically significant after applying a conservative correction.

Overall, there were no significant differences in the use of other medical or psychological services between the two groups during the study, suggesting that while PST may increase emergency visits, it did not affect overall healthcare utilization in the longer term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Telephone-Based Problem-Solving Treatment on the Use of Medical and Psychological Services in the Military. Richardson, JS., Fann, JR., Bell, KR., et al.[2022]

The study developed and evaluated a problem-solving training (PST) intervention specifically for patients undergoing hematopoietic stem cell transplantation (HSCT), demonstrating its feasibility and adaptability from an existing cancer patient manual.

Feedback from 22 patients and 5 coaches indicated that the PST was well-received, with participants finding it achievable and beneficial, suggesting it could be implemented for other patient groups in similar situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conception and Associated Evaluation of a Problem-Solving Training (PST) for Patients in the Hospital Context of Hematopoietic Stem Cell Transplantation (HSCT). Balck, F., Zimmermann, A., Neumann, A.[2015]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11220690

Problem-Solving Training for Concussion ... - NIH RePORTER The primary objective of this study will be to evaluate the effectiveness of PST-Concussion in reducing psychological distress compared to TAU. ... Mild traumatic ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05837676

NCT05837676 | Problem-Solving Training for Concussion This study seeks to address this gap by evaluating the effectiveness of a brief and flexible behavioral health treatment (Problem-Solving Training for ...

3. awspntest.apa.org awspntest.apa.org/manuscript/2023-52153-001.pdf

Rehabilitation Psychology https://doi.org/DOI. 531. 10.1007/s10488-010-0314-z. 532. Page 28. Running head: PROBLEM-SOLVING TRAINING FOR CONCUSSION. 27. Palinkas, L. A., Horwitz, S. M., ...

4. withpower.com withpower.com/trial/phase-brain-concussion-9-2023-7e519

Problem-Solving Training for Concussion Additionally, PST has shown promise in improving outcomes for stroke survivors and adolescents with traumatic brain injury, suggesting it could be beneficial ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03759223

Study Details | NCT03759223 | Enhanced Problem-Solving ... Feasibility and acceptability of a brief intervention to improve mild traumatic brain injury recovery: Problem-solving training-concussion. Rehabil Psychol ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10569252/

The Additive Benefits of Aerobic Exercise and Cognitive ... Current concussion rehabilitation paradigms using aerobic exercise may improve concussion symptoms. Additionally, cognitive training–focused rehabilitation ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S000399931931305X

Management of Concussion and Mild Traumatic Brain Injury Clinical recovery from mTBI is determined by symptom resolution, normalization of physical examination findings, and tolerance for usual daily activities ( ...