N/A
N=50
Enhanced Problem-Solving Training
Brain Concussion
Bottom Line
View on ClinicalTrials.gov: NCT03759223 ↗Enrolled (actual)
50
Serious AEs
6.0%
Results posted
Aug 2024
Primary outcome: Primary: Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score — 64.21; 65.26; 66.8; 61.35 units on a scale — p=.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enhanced Problem-Solving Training (E-PST) (Behavioral); Healthy Living Messages (HLM) (Behavioral); Enhanced Problem-Solving Training (E-PST) (non-randomized) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score |
64.21; 65.26; 66.8; 61.35; 61.11; 57.0 | .04 sig |
| SECONDARY Applied Cognition-General Concerns-Short Form (ACGC-8a) |
40.44; 44.47; 38.94; 40.80; 40.66; 44.95 | — |
| SECONDARY Applied Cognition-Abilities-Short Form (ACA-8a) |
43.16; 41.52; 44.06; 42.50; 44.46; 39.00 | — |
| SECONDARY Hopkins Verbal Learning Test-Revised (HVLT-R) |
34.11; 38.12; 38.19; 35.99; 33.88; 35.44 | — |
| SECONDARY Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span |
7.16; 6.95; 7.47; 7.10; 7.72; 7.06 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
11.95; 11.95; 11.7; 10.57; 11.07; 8.6 | — |
| SECONDARY PTSD Checklist for DSM-5 (PCL5) |
31.15; 27.90; 40.3; 31.04; 28.67; 35.3 | — |
| SECONDARY Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C) |
2.90; 4.37; 2.37; 4.21; 1.95; 4.00 | — |
| SECONDARY Brief Addictions Monitor-Revised (BAM-R) |
2.47; 3.02; 2.69; 3.91; 2.39; 3.73 | — |
| SECONDARY Pain Symptom Survey (PEG) |
5.28; 5.56; 5.36; 4.89; 4.67; 4.74 | — |
| SECONDARY Patient Global Impressions of Change (PGIC) |
4.19; 2.87; 4.19; 2.92 | — |
| SECONDARY World Health Organization Quality of Life - BREF (WHOQOL-BREF) |
12.66; 13.23; 12.21; 13.40; 12.86; 12.57 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03759223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.