Enhanced Problem-Solving Training
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/4/2019 |
| Start Date: | June 4, 2019 |
| End Date: | September 29, 2023 |
| Contact: | Paul R King, PhD |
| Email: | paul.king2@va.gov |
| Phone: | (716) 862-6038 |
Enhanced Problem-Solving Training (E-PST) to Improve Recovery From mTBI
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.
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.
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 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.
data from up to 12 participants, though clinical effect will also be evaluated using 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.
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
We found this trial at
1
site
Buffalo, New York 14215
Principal Investigator: Paul R. King, PhD
Phone: 716-862-6038
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