Clinical trial NCT03759223: Enhanced Problem-Solving Training
Official title: Enhanced Problem-Solving Training (E-PST) to Improve Recovery From mTBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Concussion
Keywords: Mild Traumatic Brain Injury
Concussion, Mild
Veterans
Stress Disorders, Post-Traumatic
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-11-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Applied Cognition-General Concerns-Short Form (ACGC-8a)
timeFrame: Up to 24 weeks
measure: Applied Cognition-Abilities-Short Form (ACA-8a)
timeFrame: Up to 24 weeks
measure: Hopkins Verbal Learning Test-Revised (HVLT-R)
timeFrame: Up to 24 weeks
measure: Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span
timeFrame: Up to 24 weeks
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Up to 24 weeks
measure: PTSD Checklist for DSM-5 (PCL5)
timeFrame: Up to 24 weeks
measure: Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C)
timeFrame: Up to 24 weeks
measure: Brief Addictions Monitor-Revised (BAM-R)
timeFrame: Up to 24 weeks
measure: Pain Symptom Survey (PEG)
timeFrame: Up to 24 weeks
measure: Patient Global Impressions of Change (PGIC)
timeFrame: Up to 24 weeks
measure: World Health Organization Quality of Life - BREF (WHOQOL-BREF)
timeFrame: Up to 24 weeks
Other outcomes:
measure: Neurobehavioral Symptom Inventory
timeFrame: Up to 24 weeks
Locations:
city: Buffalo
country: United States
facility: VA Western New York Healthcare System, Buffalo, NY
state: New York
Study officials:
affiliation: VA Western New York Healthcare System, Buffalo, NY
name: Paul R. King, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: King 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.