Enhanced Problem-Solving Training (E-PST)

VA Office of Research and Development

Status: Completed

Conditions: Brain Concussion

Treatments: Behavioral: Healthy Living Messages (HLM); Behavioral: Enhanced Problem-Solving Training (E-PST) (non-randomized); Behavioral: Enhanced Problem-Solving Training (E-PST)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03759223

RX002796 (Other Grant/Funding Number)

D2796-W

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

E-PST (randomized)

Experimental group

Description:

Enhanced Problem-Solving Training (E-PST) arm. E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. Randomized participants were assigned 1:1 to E-PST or HLM.

Treatment:

Behavioral: Enhanced Problem-Solving Training (E-PST)

Control (randomized)

Active Comparator group

Description:

Healthy Living Messages (Control) arm. Healthy Living Messages (HLM) are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care. Randomized participants were assigned 1:1 to E-PST or HLM.

Treatment:

Behavioral: Healthy Living Messages (HLM)

E-PST (non-randomized)

Other group

Description:

Enhanced Problem-Solving Training (E-PST) arm. E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. Non-randomized participants were assigned to E-PST only.

Treatment:

Behavioral: Enhanced Problem-Solving Training (E-PST) (non-randomized)