Brain Concussion
Conditions
Keywords
Mild Traumatic Brain Injury, Concussion, Mild, Veterans, Stress Disorders, Post-Traumatic
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.
Interventions
BEHAVIORALEnhanced Problem-Solving Training (E-PST)
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.
BEHAVIORALHealthy Living Messages (HLM)
Healthy Living Messages 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.
BEHAVIORALEnhanced Problem-Solving Training (E-PST) (non-randomized)
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score | Up to 24 weeks | The BSI-18 is a brief measure of psychological distress brought about by common somatic and affective symptoms. It has been validated for use in patients with history of TBI and is appropriate for use in primary care. Similar to a previous trial of PST for mTBI, its Global Severity Index (GSI) T-score will serve as the primary outcome measure. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy, sex-matched individuals) with a standard deviation of 10. GSI T-scores range from 30-80, with lower scores signaling an overall lower level of psychological distress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Applied Cognition-General Concerns-Short Form (ACGC-8a) | Up to 24 weeks | An 8-item checklist of general cognitive concerns over the past week. Items were generated and validated as part of the National Institute of Health's Patient-Reported Outcome Measurement Information System (PROMIS). Raw scores are converted to T-scores (range = 23.3-62.7), with higher scores signaling relatively fewer cognitive concerns. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy individuals) with a standard deviation of 10. |
| Applied Cognition-Abilities-Short Form (ACA-8a) | Up to 24 weeks | An 8-item checklist of self-perceived cognitive abilities over the past week, developed as part of the National Institute of Health's Patient-Reported Outcome Measurement Information System (PROMIS). Raw scores are converted to T-scores (range = 27-64.8) with higher scores signaling higher perceived cognitive abilities. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy individuals) with a standard deviation of 10. |
| Hopkins Verbal Learning Test-Revised (HVLT-R) | Up to 24 weeks | A brief test of verbal learning, recall, and recognition. Participants are read a word list over 3 learning trials, and are asked to recall as many words as possible after a 25-minute delay. Raw scores are converted to T-scores (range = 20 to 80), with higher scores signaling better verbal memory performance. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy, age-matched individuals) with a standard deviation of 10. |
| Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span | Up to 24 weeks | A brief verbal attention test. Participants are presented with a sequence of digits and asked to repeat them forward and backward. Raw scores are converted to scaled scores (range = 1-19) with corresponding percentile ranks (range = 1 to 99); higher scaled scores and percentile ranks signal better overall performance. |
| Patient Health Questionnaire-9 (PHQ-9) | Up to 24 weeks | A 9-item measure of cognitive, affective, and somatic depressive symptoms validated for use in primary care. Scores range from 0 to 27, with lower scores signaling lower mood symptoms. |
| Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C) | Up to 24 weeks | A 3-item measure of the frequency and severity of alcohol intake over the past year. Scores range from 0 to 12, with lower scores signaling less overall alcohol consumption. |
| Brief Addictions Monitor-Revised (BAM-R) | Up to 24 weeks | A 17-item measure of substance misuse and associated functional impairment. The Use subscale score ranges from 0-12, with lower scores signaling no (0) or relatively lower substance use. |
| Pain Symptom Survey (PEG) | Up to 24 weeks | A 3-item pain assessment that has been validated for use in VA patients. Respondents are asked to report their average level of pain, the average impact of pain on their ability to enjoy life, and the average level of interference on daily activities on a scale of 0 to 10. Ratings on each domain are averaged to calculate a composite score, which ranges from 0 to 10, with lower scores signaling lower overall pain. |
| Patient Global Impressions of Change (PGIC) | Up to 24 weeks | A 7-point single-item rating scale that asks patients to rate their overall impression of response to treatment. Ratings range from no change to a great deal better. Ratings range from 0 to 7, with higher ratings signaling greater perceived change in response to treatment. Because ratings are only collected after receiving a given treatment, baseline values are not collected. |
| World Health Organization Quality of Life - BREF (WHOQOL-BREF) | Up to 24 weeks | A 26-item abbreviated version of the full-length WHOQOL measure that evaluates disability and quality of life in domains such as social relationships, physical and mental health, and satisfaction with person-environment interactions. Raw scores are averaged to compute domain scores (range = 4-20), with higher scores signaling an overall higher quality of life. |
| PTSD Checklist for DSM-5 (PCL5) | Up to 24 weeks | A 20-item measure of DSM-5 symptoms related to trauma, organized over re-experiencing, avoidance, hyperarousal, and cognitive/mood domains. Score range from 0-80, with lower scores signaling less severe PTSD symptoms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Neurobehavioral Symptom Inventory | Up to 24 weeks | A 22-item checklist of affective, cognitive, and somatosensory symptoms commonly reported after concussion. Scores range from0 to 88, with lower scores signaling lower overall symptom reports. |
Countries
United States
Participant flow
Pre-assignment details
12 non-randomized (open trial) participants were enrolled to gather feasibility and acceptability data before randomizing 38 participants to E-PST or HLM control.
Participants by arm
| Arm | Count |
|---|---|
| E-PST (Randomized) 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.
Enhanced Problem-Solving Training (E-PST): E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. | 19 |
| Control (Randomized) 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.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care. | 19 |
| E-PST (Non-randomized) 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.
Enhanced Problem-Solving Training (E-PST): E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. | 12 |
| Total | 50 |
Baseline characteristics
| Characteristic | E-PST (Randomized) | Control (Randomized) | E-PST (Non-randomized) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 19 Participants | 11 Participants | 48 Participants |
| Age, Continuous | 42 years STANDARD_DEVIATION 8.7 | 42 years STANDARD_DEVIATION 7.9 | 41 years STANDARD_DEVIATION 11.4 | 42 years STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 16 Participants | 12 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 18 Participants | 12 Participants | 48 Participants |
| Region of Enrollment United States | 19 Participants | 19 Participants | 12 Participants | 50 Participants |
| Sex/Gender, Customized Female | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Sex/Gender, Customized Male | 17 Participants | 17 Participants | 12 Participants | 46 Participants |
| Sex/Gender, Customized Prefer Not to Answer | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 | 0 / 12 |
| other Total, other adverse events | 8 / 19 | 6 / 19 | 0 / 12 |
| serious Total, serious adverse events | 1 / 19 | 2 / 19 | 0 / 12 |
Outcome results
Primary
Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score
The BSI-18 is a brief measure of psychological distress brought about by common somatic and affective symptoms. It has been validated for use in patients with history of TBI and is appropriate for use in primary care. Similar to a previous trial of PST for mTBI, its Global Severity Index (GSI) T-score will serve as the primary outcome measure. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy, sex-matched individuals) with a standard deviation of 10. GSI T-scores range from 30-80, with lower scores signaling an overall lower level of psychological distress.
Time frame: Up to 24 weeks
Population: All participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-PST (Randomized) | Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score | 12 Weeks | 61.35 units on a scale | Standard Error 2.14 |
| E-PST (Randomized) | Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score | Baseline | 64.21 units on a scale | Standard Error 2.05 |
| E-PST (Randomized) | Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score | 24 Weeks | 60.85 units on a scale | Standard Error 2.14 |
| Control (Randomized) | Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score | 24 Weeks | 61.83 units on a scale | Standard Error 2.2 |
| Control (Randomized) | Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score | Baseline | 65.26 units on a scale | Standard Error 2.05 |
| Control (Randomized) | Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score | 12 Weeks | 61.11 units on a scale | Standard Error 2.17 |
| E-PST (Non-randomized) | Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score | 12 Weeks | 57.0 units on a scale | Standard Error 8.3 |
| E-PST (Non-randomized) | Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score | Baseline | 66.8 units on a scale | Standard Error 7.9 |
p-value: 0.04Mixed Models Analysis
p-value: 0.05Mixed Models Analysis
p-value: 0.58Mixed Models Analysis
Secondary
Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C)
A 3-item measure of the frequency and severity of alcohol intake over the past year. Scores range from 0 to 12, with lower scores signaling less overall alcohol consumption.
Time frame: Up to 24 weeks
Population: Randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-PST (Randomized) | Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C) | Baseline | 2.90 units on a scale | Standard Error 0.62 |
| E-PST (Randomized) | Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C) | 12 Weeks | 2.37 units on a scale | Standard Error 0.63 |
| E-PST (Randomized) | Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C) | 24 Weeks | 1.95 units on a scale | Standard Error 0.63 |
| Control (Randomized) | Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C) | Baseline | 4.37 units on a scale | Standard Error 0.61 |
| Control (Randomized) | Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C) | 12 Weeks | 4.21 units on a scale | Standard Error 0.63 |
| Control (Randomized) | Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C) | 24 Weeks | 4.00 units on a scale | Standard Error 0.64 |
Secondary
Applied Cognition-Abilities-Short Form (ACA-8a)
An 8-item checklist of self-perceived cognitive abilities over the past week, developed as part of the National Institute of Health's Patient-Reported Outcome Measurement Information System (PROMIS). Raw scores are converted to T-scores (range = 27-64.8) with higher scores signaling higher perceived cognitive abilities. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy individuals) with a standard deviation of 10.
Time frame: Up to 24 weeks
Population: Randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-PST (Randomized) | Applied Cognition-Abilities-Short Form (ACA-8a) | Baseline | 43.16 units on a scale | Standard Error 1.65 |
| E-PST (Randomized) | Applied Cognition-Abilities-Short Form (ACA-8a) | 12 Weeks | 44.06 units on a scale | Standard Error 1.75 |
| E-PST (Randomized) | Applied Cognition-Abilities-Short Form (ACA-8a) | 24 Weeks | 44.46 units on a scale | Standard Error 1.74 |
| Control (Randomized) | Applied Cognition-Abilities-Short Form (ACA-8a) | Baseline | 41.52 units on a scale | Standard Error 1.65 |
| Control (Randomized) | Applied Cognition-Abilities-Short Form (ACA-8a) | 12 Weeks | 42.50 units on a scale | Standard Error 1.78 |
| Control (Randomized) | Applied Cognition-Abilities-Short Form (ACA-8a) | 24 Weeks | 39.00 units on a scale | Standard Error 1.82 |
Secondary
Applied Cognition-General Concerns-Short Form (ACGC-8a)
An 8-item checklist of general cognitive concerns over the past week. Items were generated and validated as part of the National Institute of Health's Patient-Reported Outcome Measurement Information System (PROMIS). Raw scores are converted to T-scores (range = 23.3-62.7), with higher scores signaling relatively fewer cognitive concerns. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy individuals) with a standard deviation of 10.
Time frame: Up to 24 weeks
Population: Randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-PST (Randomized) | Applied Cognition-General Concerns-Short Form (ACGC-8a) | Baseline | 40.44 units on a scale | Standard Error 1.71 |
| E-PST (Randomized) | Applied Cognition-General Concerns-Short Form (ACGC-8a) | 12 Weeks | 38.94 units on a scale | Standard Error 1.8 |
| E-PST (Randomized) | Applied Cognition-General Concerns-Short Form (ACGC-8a) | 24 Weeks | 40.66 units on a scale | Standard Error 1.8 |
| Control (Randomized) | Applied Cognition-General Concerns-Short Form (ACGC-8a) | Baseline | 44.47 units on a scale | Standard Error 1.71 |
| Control (Randomized) | Applied Cognition-General Concerns-Short Form (ACGC-8a) | 12 Weeks | 40.80 units on a scale | Standard Error 1.83 |
| Control (Randomized) | Applied Cognition-General Concerns-Short Form (ACGC-8a) | 24 Weeks | 44.95 units on a scale | Standard Error 1.86 |
Secondary
Brief Addictions Monitor-Revised (BAM-R)
A 17-item measure of substance misuse and associated functional impairment. The Use subscale score ranges from 0-12, with lower scores signaling no (0) or relatively lower substance use.
Time frame: Up to 24 weeks
Population: Randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-PST (Randomized) | Brief Addictions Monitor-Revised (BAM-R) | Baseline | 2.47 units on a scale | Standard Error 0.65 |
| E-PST (Randomized) | Brief Addictions Monitor-Revised (BAM-R) | 12 Weeks | 2.69 units on a scale | Standard Error 0.72 |
| E-PST (Randomized) | Brief Addictions Monitor-Revised (BAM-R) | 24 Weeks | 2.39 units on a scale | Standard Error 0.75 |
| Control (Randomized) | Brief Addictions Monitor-Revised (BAM-R) | Baseline | 3.02 units on a scale | Standard Error 0.59 |
| Control (Randomized) | Brief Addictions Monitor-Revised (BAM-R) | 12 Weeks | 3.91 units on a scale | Standard Error 0.61 |
| Control (Randomized) | Brief Addictions Monitor-Revised (BAM-R) | 24 Weeks | 3.73 units on a scale | Standard Error 0.65 |
Secondary
Hopkins Verbal Learning Test-Revised (HVLT-R)
A brief test of verbal learning, recall, and recognition. Participants are read a word list over 3 learning trials, and are asked to recall as many words as possible after a 25-minute delay. Raw scores are converted to T-scores (range = 20 to 80), with higher scores signaling better verbal memory performance. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy, age-matched individuals) with a standard deviation of 10.
Time frame: Up to 24 weeks
Population: Randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-PST (Randomized) | Hopkins Verbal Learning Test-Revised (HVLT-R) | Baseline- Delayed Recall T-Score | 34.11 units on a scale | Standard Error 2.66 |
| E-PST (Randomized) | Hopkins Verbal Learning Test-Revised (HVLT-R) | 12 Weeks- Delayed Recall T-Score | 38.19 units on a scale | Standard Error 2.82 |
| E-PST (Randomized) | Hopkins Verbal Learning Test-Revised (HVLT-R) | 24 Weeks- Delayed Recall T-Score | 33.88 units on a scale | Standard Error 2.82 |
| Control (Randomized) | Hopkins Verbal Learning Test-Revised (HVLT-R) | Baseline- Delayed Recall T-Score | 38.12 units on a scale | Standard Error 2.7 |
| Control (Randomized) | Hopkins Verbal Learning Test-Revised (HVLT-R) | 12 Weeks- Delayed Recall T-Score | 35.99 units on a scale | Standard Error 2.88 |
| Control (Randomized) | Hopkins Verbal Learning Test-Revised (HVLT-R) | 24 Weeks- Delayed Recall T-Score | 35.44 units on a scale | Standard Error 2.94 |
Secondary
Pain Symptom Survey (PEG)
A 3-item pain assessment that has been validated for use in VA patients. Respondents are asked to report their average level of pain, the average impact of pain on their ability to enjoy life, and the average level of interference on daily activities on a scale of 0 to 10. Ratings on each domain are averaged to calculate a composite score, which ranges from 0 to 10, with lower scores signaling lower overall pain.
Time frame: Up to 24 weeks
Population: Randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-PST (Randomized) | Pain Symptom Survey (PEG) | Baseline | 5.28 units on a scale | Standard Error 0.51 |
| E-PST (Randomized) | Pain Symptom Survey (PEG) | 12 Weeks | 5.36 units on a scale | Standard Error 0.54 |
| E-PST (Randomized) | Pain Symptom Survey (PEG) | 24 Weeks | 4.67 units on a scale | Standard Error 0.54 |
| Control (Randomized) | Pain Symptom Survey (PEG) | Baseline | 5.56 units on a scale | Standard Error 0.51 |
| Control (Randomized) | Pain Symptom Survey (PEG) | 12 Weeks | 4.89 units on a scale | Standard Error 0.55 |
| Control (Randomized) | Pain Symptom Survey (PEG) | 24 Weeks | 4.74 units on a scale | Standard Error 0.56 |
Secondary
Patient Global Impressions of Change (PGIC)
A 7-point single-item rating scale that asks patients to rate their overall impression of response to treatment. Ratings range from no change to a great deal better. Ratings range from 0 to 7, with higher ratings signaling greater perceived change in response to treatment. Because ratings are only collected after receiving a given treatment, baseline values are not collected.
Time frame: Up to 24 weeks
Population: Randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-PST (Randomized) | Patient Global Impressions of Change (PGIC) | 12 weeks | 4.19 units on a scale | Standard Error 0.44 |
| E-PST (Randomized) | Patient Global Impressions of Change (PGIC) | 24 weeks | 4.19 units on a scale | Standard Error 0.47 |
| Control (Randomized) | Patient Global Impressions of Change (PGIC) | 12 weeks | 2.87 units on a scale | Standard Error 0.46 |
| Control (Randomized) | Patient Global Impressions of Change (PGIC) | 24 weeks | 2.92 units on a scale | Standard Error 0.51 |
Secondary
Patient Health Questionnaire-9 (PHQ-9)
A 9-item measure of cognitive, affective, and somatic depressive symptoms validated for use in primary care. Scores range from 0 to 27, with lower scores signaling lower mood symptoms.
Time frame: Up to 24 weeks
Population: All participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-PST (Randomized) | Patient Health Questionnaire-9 (PHQ-9) | 12 Weeks | 10.57 units on a scale | Standard Error 1.38 |
| E-PST (Randomized) | Patient Health Questionnaire-9 (PHQ-9) | Baseline | 11.95 units on a scale | Standard Error 1.32 |
| E-PST (Randomized) | Patient Health Questionnaire-9 (PHQ-9) | 24 Weeks | 8.82 units on a scale | Standard Error 1.38 |
| Control (Randomized) | Patient Health Questionnaire-9 (PHQ-9) | 24 Weeks | 12.24 units on a scale | Standard Error 1.41 |
| Control (Randomized) | Patient Health Questionnaire-9 (PHQ-9) | Baseline | 11.95 units on a scale | Standard Error 1.32 |
| Control (Randomized) | Patient Health Questionnaire-9 (PHQ-9) | 12 Weeks | 11.07 units on a scale | Standard Error 1.39 |
| E-PST (Non-randomized) | Patient Health Questionnaire-9 (PHQ-9) | 12 Weeks | 8.6 units on a scale | Standard Error 6.7 |
| E-PST (Non-randomized) | Patient Health Questionnaire-9 (PHQ-9) | Baseline | 11.7 units on a scale | Standard Error 6.7 |
Secondary
PTSD Checklist for DSM-5 (PCL5)
A 20-item measure of DSM-5 symptoms related to trauma, organized over re-experiencing, avoidance, hyperarousal, and cognitive/mood domains. Score range from 0-80, with lower scores signaling less severe PTSD symptoms.
Time frame: Up to 24 weeks
Population: Randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-PST (Randomized) | PTSD Checklist for DSM-5 (PCL5) | 12 Weeks | 31.04 units on a scale | Standard Error 5 |
| E-PST (Randomized) | PTSD Checklist for DSM-5 (PCL5) | Baseline | 31.15 units on a scale | Standard Error 4.8 |
| E-PST (Randomized) | PTSD Checklist for DSM-5 (PCL5) | 24 Weeks | 24.52 units on a scale | Standard Error 5.2 |
| Control (Randomized) | PTSD Checklist for DSM-5 (PCL5) | 24 Weeks | 30.30 units on a scale | Standard Error 5.43 |
| Control (Randomized) | PTSD Checklist for DSM-5 (PCL5) | Baseline | 27.90 units on a scale | Standard Error 5.19 |
| Control (Randomized) | PTSD Checklist for DSM-5 (PCL5) | 12 Weeks | 28.67 units on a scale | Standard Error 5.43 |
| E-PST (Non-randomized) | PTSD Checklist for DSM-5 (PCL5) | 12 Weeks | 35.3 units on a scale | Standard Error 18.9 |
| E-PST (Non-randomized) | PTSD Checklist for DSM-5 (PCL5) | Baseline | 40.3 units on a scale | Standard Error 17.9 |
Secondary
Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span
A brief verbal attention test. Participants are presented with a sequence of digits and asked to repeat them forward and backward. Raw scores are converted to scaled scores (range = 1-19) with corresponding percentile ranks (range = 1 to 99); higher scaled scores and percentile ranks signal better overall performance.
Time frame: Up to 24 weeks
Population: Randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-PST (Randomized) | Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span | Baseline | 7.16 score on a scale | Standard Error 0.35 |
| E-PST (Randomized) | Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span | 12 Weeks | 7.47 score on a scale | Standard Error 0.37 |
| E-PST (Randomized) | Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span | 24 Weeks | 7.72 score on a scale | Standard Error 0.37 |
| Control (Randomized) | Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span | Baseline | 6.95 score on a scale | Standard Error 0.35 |
| Control (Randomized) | Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span | 12 Weeks | 7.10 score on a scale | Standard Error 0.37 |
| Control (Randomized) | Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span | 24 Weeks | 7.06 score on a scale | Standard Error 0.38 |
Secondary
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
A 26-item abbreviated version of the full-length WHOQOL measure that evaluates disability and quality of life in domains such as social relationships, physical and mental health, and satisfaction with person-environment interactions. Raw scores are averaged to compute domain scores (range = 4-20), with higher scores signaling an overall higher quality of life.
Time frame: Up to 24 weeks
Population: Randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-PST (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | Baseline- Physical | 12.66 units on a scale | Standard Error 0.59 |
| E-PST (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | 12 weeks- Physical | 12.21 units on a scale | Standard Error 0.62 |
| E-PST (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | 24 weeks- Physical | 12.86 units on a scale | Standard Error 0.62 |
| E-PST (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | Baseline- Psychological | 13.02 units on a scale | Standard Error 0.71 |
| E-PST (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | 12 weeks- Psychological | 13.35 units on a scale | Standard Error 0.74 |
| E-PST (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | 24 weeks- Psychological | 13.18 units on a scale | Standard Error 0.74 |
| E-PST (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | Baseline- Social | 12.63 units on a scale | Standard Error 0.84 |
| E-PST (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | 12 weeks- Social | 12.43 units on a scale | Standard Error 0.87 |
| E-PST (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | 24 weeks- Social | 13.18 units on a scale | Standard Error 0.87 |
| E-PST (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | Baseline- Environment | 15.82 units on a scale | Standard Error 0.46 |
| E-PST (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | 12 weeks- Environment | 15.41 units on a scale | Standard Error 0.49 |
| E-PST (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | 24 weeks- Environment | 15.83 units on a scale | Standard Error 0.49 |
| Control (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | 12 weeks- Environment | 16.50 units on a scale | Standard Error 0.5 |
| Control (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | Baseline- Physical | 13.23 units on a scale | Standard Error 0.59 |
| Control (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | Baseline- Social | 15.02 units on a scale | Standard Error 0.84 |
| Control (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | 12 weeks- Physical | 13.40 units on a scale | Standard Error 0.64 |
| Control (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | Baseline- Environment | 16.39 units on a scale | Standard Error 0.46 |
| Control (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | 24 weeks- Physical | 12.57 units on a scale | Standard Error 0.65 |
| Control (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | 12 weeks- Social | 14.64 units on a scale | Standard Error 0.88 |
| Control (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | Baseline- Psychological | 13.05 units on a scale | Standard Error 0.71 |
| Control (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | 24 weeks- Environment | 16.12 units on a scale | Standard Error 0.51 |
| Control (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | 12 weeks- Psychological | 12.59 units on a scale | Standard Error 0.75 |
| Control (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | 24 weeks- Social | 13.98 units on a scale | Standard Error 0.9 |
| Control (Randomized) | World Health Organization Quality of Life - BREF (WHOQOL-BREF) | 24 weeks- Psychological | 11.83 units on a scale | Standard Error 0.76 |
Other Pre-specified
Neurobehavioral Symptom Inventory
A 22-item checklist of affective, cognitive, and somatosensory symptoms commonly reported after concussion. Scores range from0 to 88, with lower scores signaling lower overall symptom reports.
Time frame: Up to 24 weeks
Population: Randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-PST (Randomized) | Neurobehavioral Symptom Inventory | 12 weeks | 40.35 units on a scale | Standard Error 3.7 |
| E-PST (Randomized) | Neurobehavioral Symptom Inventory | Baseline | 42.42 units on a scale | Standard Error 3.59 |
| E-PST (Randomized) | Neurobehavioral Symptom Inventory | 24 weeks | 37.79 units on a scale | Standard Error 3.7 |
| Control (Randomized) | Neurobehavioral Symptom Inventory | 24 weeks | 38.81 units on a scale | Standard Error 3.78 |
| Control (Randomized) | Neurobehavioral Symptom Inventory | Baseline | 41.42 units on a scale | Standard Error 3.59 |
| Control (Randomized) | Neurobehavioral Symptom Inventory | 12 weeks | 38.02 units on a scale | Standard Error 3.74 |
| E-PST (Non-randomized) | Neurobehavioral Symptom Inventory | 12 weeks | 35.3 units on a scale | Standard Error 17.4 |
| E-PST (Non-randomized) | Neurobehavioral Symptom Inventory | Baseline | 43.3 units on a scale | Standard Error 17.2 |