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| ID | Type | Description | Link |
|---|---|---|---|
| RX002796 | Other Grant/Funding Number | VA Rehabilitation Research & Development (RR&D) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-PST (randomized) | Experimental | 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. |
|
| Control (randomized) | Active Comparator | 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. |
|
| E-PST (non-randomized) | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Problem-Solving Training (E-PST) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul R. King, PhD | VA Western New York Healthcare System, Buffalo, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Western New York Healthcare System, Buffalo, NY | Buffalo | New York | 14215-1129 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34446984 | Background | 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. | |
| 36892882 | Background |
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Final data sets underlying all publications resulting from the proposed research will be shared outside VA. A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
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Requests will be considered beginning 6 months after final publication.
Limited datasets in machine-readable electronic format will be created and shared pursuant to a Data Use Agreement (DUA). Appropriate use of the electronic dataset will be specified, as will prohibitions against identifying or re-identifying (i.e., taking steps to identify or re-identify) any individual whose data are included in the dataset.
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12 non-randomized (open trial) participants were enrolled to gather feasibility and acceptability data before randomizing 38 participants to E-PST or HLM control.
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| ID | Title | Description |
|---|---|---|
| FG000 | E-PST (Randomized) | Enhanced Problem-Solving Training (E-PST) randomized arm. E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. 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. |
| FG001 | Control (Randomized) | Healthy Living Messages (Control) randomized arm. Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care. Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care. |
| FG002 | E-PST (Non-randomized) | Enhanced Problem-Solving Training (E-PST) non-randomized arm. E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. Participants in this open label arm provided feasibility and acceptability data on treatment components. Limited clinical data were collected. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants | Posted | Mean | Standard Error | units on a scale | Up to 24 weeks |
|
Up to 24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Strain/sprain or contusion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emotional distress, depression | Psychiatric disorders | Non-systematic Assessment |
This study emphasized feasibility and acceptability metrics. Given the small number of participants enrolled in the randomized pilot trial, there was not sufficient power to robustly detect clinical effects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul King, Clinical Research Psychologist | VA Center for Integrated Healthcare | 716-862-6038 | paul.king2@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 30, 2021 | May 9, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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|
| Healthy Living Messages (HLM) | Behavioral | 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. |
|
|
| Enhanced Problem-Solving Training (E-PST) (non-randomized) | Behavioral | 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. |
|
|
| Up to 24 weeks |
| 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. | Up to 24 weeks |
| 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. | Up to 24 weeks |
| 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. | Up to 24 weeks |
| 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. | Up to 24 weeks |
| 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. | Up to 24 weeks |
| 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. | Up to 24 weeks |
| 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. | Up to 24 weeks |
| 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. | Up to 24 weeks |
| 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. | Up to 24 weeks |
| 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. | Up to 24 weeks |
| 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Control (Randomized) | Healthy Living Messages (Control) arm. 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. Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care. |
| OG002 | 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. |
|
|
|
| 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. | Randomized participants | Posted | Mean | Standard Error | units on a scale | Up to 24 weeks |
|
|
|
| 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. | Randomized participants | Posted | Mean | Standard Error | units on a scale | Up to 24 weeks |
|
|
|
| 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. | Randomized participants | Posted | Mean | Standard Error | units on a scale | Up to 24 weeks |
|
|
|
| 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. | Randomized participants | Posted | Mean | Standard Error | score on a scale | Up to 24 weeks |
|
|
|
| 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. | All participants | Posted | Mean | Standard Error | units on a scale | Up to 24 weeks |
|
|
|
| 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. | Randomized participants | Posted | Mean | Standard Error | units on a scale | Up to 24 weeks |
|
|
|
| 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. | Randomized participants | Posted | Mean | Standard Error | units on a scale | Up to 24 weeks |
|
|
|
| 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. | Randomized participants | Posted | Mean | Standard Error | units on a scale | Up to 24 weeks |
|
|
|
| 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. | Randomized participants | Posted | Mean | Standard Error | units on a scale | Up to 24 weeks |
|
|
|
| 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. | Randomized participants | Posted | Mean | Standard Error | units on a scale | Up to 24 weeks |
|
|
|
| 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. | Randomized participants | Posted | Mean | Standard Error | units on a scale | Up to 24 weeks |
|
|
|
| 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. | Randomized participants | Posted | Mean | Standard Error | units on a scale | Up to 24 weeks |
|
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|
| 0 |
| 19 |
| 1 |
| 19 |
| 8 |
| 19 |
| EG001 | 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. | 0 | 19 | 2 | 19 | 6 | 19 |
| EG002 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
|
| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| COVID | Infections and infestations | Non-systematic Assessment | Positive COVID-19 diagnosis, respiratory symptoms |
|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| 12 Weeks |
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| 24 Weeks |
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| 12 Weeks |
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| 24 Weeks |
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| 12 Weeks- Delayed Recall T-Score |
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| 24 Weeks- Delayed Recall T-Score |
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| 12 Weeks |
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| 24 Weeks |
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| 12 Weeks |
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| 24 Weeks |
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| 12 Weeks |
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| 24 Weeks |
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| 12 Weeks |
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| 24 Weeks |
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| 12 Weeks |
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| 24 Weeks |
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| 12 Weeks |
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| 24 Weeks |
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| 24 weeks |
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| 12 weeks- Physical |
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| 24 weeks- Physical |
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| Baseline- Psychological |
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| 12 weeks- Psychological |
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| 24 weeks- Psychological |
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| Baseline- Social |
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| 12 weeks- Social |
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| 24 weeks- Social |
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| Baseline- Environment |
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| 12 weeks- Environment |
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| 24 weeks- Environment |
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| 12 weeks |
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| 24 weeks |
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