Problem-Solving Training for Concussion

(PST-Concussion Trial)

Overseen by Paul R. King, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Moderate to severe TBI, Psychotic disorder, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called PST-Concussion to help Veterans with mild traumatic brain injury manage their symptoms. The study aims to see if this treatment can reduce psychological distress and improve overall functioning. If successful, it could offer a practical way to support Veterans' recovery. Problem-solving treatment (PST) has been previously explored as a method to help service members with mild traumatic brain injury manage their symptoms.

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 data supports the effectiveness of the treatment Problem Solving Training for Concussion?

Research shows that problem-solving therapy (PST) has been effective in various settings, such as reducing the use of medical services in military personnel with mild traumatic brain injury and helping older patients resolve health-related issues. Additionally, PST has shown promise in improving outcomes for stroke survivors and adolescents with traumatic brain injury, suggesting it could be beneficial for concussion patients as well. ^{1 2 3 4 5}

Is Problem-Solving Training for Concussion safe for humans?

Research on Problem-Solving Training (PST) for conditions like mild traumatic brain injury (mTBI) in military service members shows it is generally safe, with participants experiencing improvements in psychological distress and other symptoms without reported safety concerns. ^{1 5 6 7 8}

How is Problem Solving Training for Concussion different from other treatments for concussion?

Problem Solving Training for Concussion is unique because it involves structured therapy sessions, often delivered over the phone, focusing on improving problem-solving skills to help manage psychological and physical symptoms of concussion. Unlike standard treatments, it emphasizes cognitive skill development and can be administered remotely, making it accessible for those unable to attend in-person sessions. ^{1 5 6 9 10}

Research Team

Paul R. King, PhD

Principal Investigator

VA Western New York Healthcare System, Buffalo, NY

Eligibility Criteria

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 been experiencing memory or thinking problems for 3 months or more.

English-speaking Veteran enrolled in VHA care

Current psychological distress

Exclusion Criteria

I have a serious brain injury or cognitive disorder.

Acute suicidal ideation

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

Trial Timeline

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)

Treatment Details

Interventions

• Problem Solving Training for Concussion (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

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]

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]

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 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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of Telephone-Based Problem-Solving Treatment on the Use of Medical and Psychological Services in the Military. [2022]

2. United States 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). [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Patient-centered approach to building problem solving skills among older primary care patients: problems identified and resolved. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a Pilot Study of Problem-Solving Therapy for Stroke Survivors. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Online problem-solving therapy after traumatic brain injury: a randomized controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Telephone Problem Solving for Service Members with Mild Traumatic Brain Injury: A Randomized, Clinical Trial. [2022]

7. United States 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. [2023]

8. United States 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. [2022]

9. Hungary pubmed.ncbi.nlm.nih.gov

[An effective method of therapy in suicide prevention: problem solving training in the clinical population]. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Problem-solving training for family caregivers of persons with traumatic brain injuries: a randomized controlled trial. [2021]