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The primary objective of this study is to evaluate the efficacy of Cognitively Augmented Behavioral Activation (CABA), a new hybrid treatment for Veterans diagnosed with comorbid mild Traumatic Brain Injury (mTBI) and posttraumatic stress disorder (PTSD). The study's specific goals are to determine whether: 1) CABA reduces PTSD symptoms in Veterans with mTBI/PTSD, 2) CABA reduces cognitive-related functional impairment in Veterans with mTBI/PTSD, 3) CABA results in improvements in depression symptoms, cognitive functioning, and quality of life in Veterans with mTBI/PTSD; and 4) CABA is an acceptable treatment for Veterans with mTBI/PTSD. The overall goal is to develop an evidence-based manualized treatment for comorbid mTBI/PTSD that can be readily implemented in Veterans Health Administration (VHA) treatment settings.
Veterans historically exhibit high rates of comorbid mTBI/PTSD. Given the comorbidity and neuropsychiatric symptom overlap of these disorders, it can be difficult to determine whether problems and disruptions in functioning are due to mTBI, PTSD, or both. Hence, it is challenging for providers to know how to prioritize these patients' clinical issues and how to effectively treat them. Currently, there are no evidence-based treatments for comorbid mTBI/PTSD. Further, it is unclear to what extent existing treatments for each disorder can be adherently and effectively implemented for the other. As such, most current treatment recommendations suggest a holistic or integrated approach to treatment for comorbid mTBI/PTSD targeting symptoms and functionality rather than underlying etiology. Investigators are proposing a treatment for comorbid mTBI and PTSD that directly targets daily functioning and quality of life.
The study design makes use of the convergent availability of resources at the two participating Veterans Administration Health Care Systems in Portland, Oregon, and Seattle, Washington to conduct a Randomized Controlled Trial (RCT) of CABA. The study will recruit a total of 192 Veterans less than or equal to 55 years of age, 96 participants at each site, enrolled at participating VA Medical Centers (VAMCs) who are diagnosed with both mTBI and PTSD. Eligible participants will be randomly assigned to either the CABA or Treatment as Usual (TAU) group. Participants in the CABA group will receive the CABA intervention during the first 14 weeks of their participation in the study, whereas TAU participants will continue to receive TAU (usual care in a PTSD specialty treatment clinic, but no CABA) during their participation in the study. Both groups will undergo evaluations at baseline, 7 weeks (mid-treatment), 14 weeks (post-treatment), and 39 weeks (6 month follow-up). During their study participation, all participants will continue to receive their usual medical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CABA | Experimental | CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. |
|
| TAU | Placebo Comparator | Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitively Augmented Behavioral Activation | Behavioral | CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Symptoms From Baseline as Measured by the Clinician Administered PTSD Scale - 5 | The Clinician Administered PTSD Scale (CAPS-IV; Blake et al., 1995; Weathers, Keane, & Davidson, 2001) was used to assess initial PTSD diagnosis (DSM-IV; APA, 2000) and PTSD symptom severity across assessment time points. The CAPS is considered a "gold standard" for assessing PTSD. Items are ranked on Likert scales according to both frequency (0-4) and intensity of symptoms (0-4), yielding an overall severity score based on the sum of frequency and intensity ratings across 17 items (range 0-136) . For this study, a diagnosis of PTSD was based on a scoring rule for items to be considered present of at least a "1" on frequency and "2" on intensity, with an overall severity score of at least 45 (Weathers, Ruscio, & Keane, 1999). | 0 weeks |
| PTSD Symptoms at 14 Weeks as Measured by the Clinician Administered PTSD Scale - 5 | The Clinician Administered PTSD Scale (CAPS-IV; Blake et al., 1995; Weathers, Keane, & Davidson, 2001) was used to assess initial PTSD diagnosis (DSM-IV; APA, 2000) and PTSD symptom severity across assessment time points. The CAPS is considered a "gold standard" for assessing PTSD. Items are ranked on Likert scales according to both frequency (0-4) and intensity of symptoms (0-4), yielding an overall severity score based on the sum of frequency and intensity ratings across 17 items (range 0-136) . For this study, a diagnosis of PTSD was based on a scoring rule for items to be considered present of at least a "1" on frequency and "2" on intensity, with an overall severity score of at least 45 (Weathers, Ruscio, & Keane, 1999). | 14 weeks |
| PTSD Symptoms From Baseline as Measured by the PTSD Checklist-5 | The Posttraumatic Stress Disorder Checklist-Fifth Edition (PCL-5; Blanchard, Jones-Alexander, Buckley, & Forneris, 1996; Weathers, Litz, Herman, Huska, & Keane, 1993; Weathers et al., 2013) was used to assess participants subjective PTSD related distress. The PCL-5 is a 20 item self-report measure that assesses the presence of DSM-5 PTSD symptoms. Items are rated on a 5-point Likert scale ranging from 0 to 4 according to how much the symptom bothered the respondent over the past month. Total scores with scores range from 0-80, with higher scores indicating more symptomatic distress. Scores totaling 31 or more are associated with presumptive PTSD among military populations. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of Depression From Baseline as Measured by the Beck Depression Inventory -II | The Beck Depression Inventory-II (BDI-II; Beck, Steer, & Brown, 1996) is a 21-item measure of subjective levels of depression. Items are rated on a 3-point Likert scale with higher scores reflecting greater severity of symptoms (range 0-63). | 0 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Use of Cognitive Strategies From Baseline as Measured by the Memory Compensation Questionnaire | Memory Compensation Questionnaire (MCQ)70. Rates the extent to which patients use various strategies to improve memory performance. 44 Items are rated on a 5-point Likert scale with higher scores indicating grater use of compensatory strategies (range 0-176). | 0 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan Callahan, PsyD | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | United States | ||
| VA Puget Sound Health Care System Seattle Division, Seattle, WA |
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| ID | Title | Description |
|---|---|---|
| FG000 | CABA | CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. |
| FG001 | Treatment as Usual (TAU) | Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CABA | CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. |
| 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 | PTSD Symptoms From Baseline as Measured by the Clinician Administered PTSD Scale - 5 | The Clinician Administered PTSD Scale (CAPS-IV; Blake et al., 1995; Weathers, Keane, & Davidson, 2001) was used to assess initial PTSD diagnosis (DSM-IV; APA, 2000) and PTSD symptom severity across assessment time points. The CAPS is considered a "gold standard" for assessing PTSD. Items are ranked on Likert scales according to both frequency (0-4) and intensity of symptoms (0-4), yielding an overall severity score based on the sum of frequency and intensity ratings across 17 items (range 0-136) . For this study, a diagnosis of PTSD was based on a scoring rule for items to be considered present of at least a "1" on frequency and "2" on intensity, with an overall severity score of at least 45 (Weathers, Ruscio, & Keane, 1999). | The total number of participants analyzed at baseline. | Posted | Mean | Standard Deviation | score on a scale | 0 weeks |
|
Baseline to 6-month follow up. AEs were documented at baseline, 7 weeks, 14 weeks, and 39 weeks, or in between visits if study staff were alerted to an event during treatment.
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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 | CABA | CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Panic Attack | Psychiatric disorders | Non-systematic Assessment | Patient had a panic attack during the session. She was walked to the ED and discharged a short time later. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Passive SI | Psychiatric disorders | Non-systematic Assessment |
This study experienced significant recruitment delays and difficulties associated with delayed IRB approvals and COVID-era shutdowns. As a result, the sample size is smaller than expected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Megan Callahan | Portland VA | 503-220-8262 | 50525 | megan.callahan@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 | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 12, 2020 | Mar 15, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D013313 | Stress Disorders, Post-Traumatic |
| D001930 | Brain Injuries |
| D009104 | Multiple Trauma |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as Usual | Behavioral | TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need. |
|
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| 0 weeks |
| PTSD Symptoms at 14 Weeks as Measured by the PTSD Checklist-5 | The Posttraumatic Stress Disorder Checklist-Fifth Edition (PCL-5; Blanchard, Jones-Alexander, Buckley, & Forneris, 1996; Weathers, Litz, Herman, Huska, & Keane, 1993; Weathers et al., 2013) was used to assess participants subjective PTSD related distress. The PCL-5 is a 20 item self-report measure that assesses the presence of DSM-5 PTSD symptoms. Items are rated on a 5-point Likert scale ranging from 0 to 4 according to how much the symptom bothered the respondent over the past month. Total scores with scores range from 0-80, with higher scores indicating more symptomatic distress. Scores totaling 31 or more are associated with presumptive PTSD among military populations. | 14 weeks |
| Baseline Memory as Measured by the Hopkins Verbal Memory Test - Revised | The Hopkins Verbal Memory Test-Revised (HVLT-R; Brandt, 1991) is a measure of uncontextualized verbal learning and delayed recall. This score is converted to a standardized T-score (mean =50, S =10). The lower the T-score, the worse the performance. | 0 weeks |
| Memory at 14 Weeks as Measured by the Hopkins Verbal Memory Test - Revised | The Hopkins Verbal Memory Test-Revised (HVLT-R; Brandt, 1991) is a measure of uncontextualized verbal learning and delayed recall. This score is converted to a standardized T-score (mean =50, S =10). The lower the T-score, the worse the performance. | 14 weeks |
| Attention and Working Memory From Baseline as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest | The Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtest (WAIS-IV; Wechsler, D., 2008) is a measure of attention and working memory. A higher total score indicates a higher level of performance (range 0-48). Raw scores are converted to scaled scores (e.g., 1-20), with higher scaled scores indicating a higher level of performance. | 0 weeks |
| Attention and Working Memory at 14 Weeks as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest | The Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtest (WAIS-IV; Wechsler, D., 2008) is a measure of attention and working memory. A higher total score indicates a higher level of performance (range 0-48). Raw scores are converted to scaled scores (e.g., 1-20), with higher scaled scores indicating a higher level of performance. | 14 weeks |
| Verbal Fluency From Baseline as Measured by the Controlled Oral Word Association Test | The Controlled Oral Word Association Test (COWAT; Ruff et al., 1996; Spreen, 1998) is a commonly used phonemic and semantic fluency word production test. A higher score indicates a higher level of performance (range 0-patient maximum). | 0 weeks |
| Verbal Fluency at 14 Weeks as Measured by the Controlled Oral Word Association Test | The Controlled Oral Word Association Test (COWAT; Ruff et al., 1996; Spreen, 1998) is a commonly used phonemic and semantic fluency word production test. A higher score indicates a higher level of performance (range 0-patient maximum). | 14 weeks |
| Delis-Kaplan Executive Functions Scale (DKEFS) - Trails Subtest at Baseline | The Delis-Kaplan Executive Function System, Trail Making subtest (D-KEFS; Delis, Kaplan, & Kramer, 2001; Delis, Kramer, Kaplan, & Holdnack, 2004) is a visual-motor task used to measure flexibility in thinking (executive function) and processing speed. Raw scores are converted to scaled scores (e.g., 1-20). A higher score indicates a higher level of performance. This scale is measuring Trial 4. | 0 weeks |
| Processing Speed at 14 Weeks as Measured by Delis-Kaplan Executive Functions Scale (DKEFS) Trails Subtest | The Delis-Kaplan Executive Function System, Trail Making subtest (D-KEFS; Delis, Kaplan, & Kramer, 2001; Delis, Kramer, Kaplan, & Holdnack, 2004) is a visual-motor task used to measure flexibility in thinking (executive function) and processing speed. Raw scores are converted to scaled scores (e.g., 1-20). A higher score indicates a higher level of performance. This scale is measuring Trial 4. | 14 weeks |
| Symptoms of Depression at 14 Weeks as Measured by the Beck Depression Inventory -II |
The Beck Depression Inventory-II (BDI-II; Beck, Steer, & Brown, 1996) is a 21-item measure of subjective levels of depression. Items are rated on a 3-point Likert scale with higher scores reflecting greater severity of symptoms (range 0-63). |
| 14 weeks |
| Global Life Satisfaction From Baseline as Measured by the Satisfaction With Life Scale | The Satisfaction with Life Scale (SWLS; Diener, Emmons, Larsen, & Griffin, 1985) is a brief measure of global life satisfaction or quality of life. Items are rated on a 7-point Likert scale with higher scores indicating greater satisfaction (range 5-35). | 0 weeks |
| Global Life Satisfaction at 14 Weeks as Measured by the Satisfaction With Life Scale | The Satisfaction with Life Scale (SWLS; Diener, Emmons, Larsen, & Griffin, 1985) is a brief measure of global life satisfaction or quality of life. Items are rated on a 7-point Likert scale with higher scores indicating greater satisfaction (range 5-35). | 14 weeks |
| Postconcussion Symptoms From Baseline as Measured by the Neurobehavioral Symptom Inventory | The Neurobehavioral Symptom Inventory (NSI; Cicerone, K.D. & Kalmer, K., 1995) is a post-concussive symptom measure recommended for use in military studies. Items are rated on a 4-point Likert scale with higher scores reflecting greater severity of symptom disturbance since time of injury (range 0-66). | 0 weeks |
| Postconcussion Symptoms at 14 Weeks as Measured by the Neurobehavioral Symptom Inventory | The Neurobehavioral Symptom Inventory (NSI; Cicerone, K.D. & Kalmer, K., 1995) is a post-concussive symptom measure recommended for use in military studies. Items are rated on a 4-point Likert scale with higher scores reflecting greater severity of symptom disturbance since time of injury (range 0-66). | 14 weeks |
| Client Satisfaction Questionnaire (CSQ) | The CSQ is an 8-item questionnaire rated on a Likert scale of 1-4 used to assess client's treatment satisfaction. Scores range from 8-32, with higher scores equaling greater satisfaction. | 14 weeks |
| Use of Cognitive Strategies at 14 Weeks as Measured by the Memory Compensation Questionnaire | Memory Compensation Questionnaire (MCQ)70. Rates the extent to which patients use various strategies to improve memory performance. 44 Items are rated on a 5-point Likert scale with higher scores indicating grater use of compensatory strategies (range 0-176). | 14 weeks |
| Postconcussion Symptoms From Baseline as Measured by the Rivermead Postconcussive Questionnaire | Rivermead Post Concussive Symptom Questionnaire (RPQ) will be used to measure postconcussive symptoms. Items are rated on a 5-point Likert scale with a higher number indicating more severe PCS (range 0-64). | 0 weeks |
| Postconcussion Symptoms at 14 Weeks as Measured by the Rivermead Postconcussive Questionnaire | Rivermead Post Concussive Symptom Questionnaire (RPQ) will be used to measure postconcussive symptoms. Items are rated on a 5-point Likert scale with a higher number indicating more severe PCS (range 0-64). | 14 weeks |
| Symptoms of Anxiety From Baseline as Measured by the Brief Symptom Inventory | Brief Symptom Inventory 18 (BSI 18) is a measure of anxiety symptoms. 18 items are rated on a 5-point Likert scale with higher scores indicating more severe symptoms (range 0-72). | 0 weeks |
| Symptoms of Anxiety at 14 Weeks as Measured by the Brief Symptom Inventory | Brief Symptom Inventory 18 (BSI 18) is a measure of anxiety symptoms. 18 items are rated on a 5-point Likert scale with higher scores indicating more severe symptoms (range 0-72). | 14 weeks |
| Health Related Quality of Life From Baseline as Measured by the Neuro-Quality of Life Satisfaction With Social Roles and Activities. | Neuro-QOL Satisfaction with Social Roles and Activities is a health-related quality of life assessment tool. Eight items are rated on a 5-point Likert scale. Scores were converted to T-scores (mean = 50; SD = 10). Lower T-scores indicate greater dissatisfaction. | 0 weeks |
| Health Related Quality of Life at 14 Weeks as Measured by the Neuro-Quality of Life Satisfaction With Social Roles and Activities. | Neuro-QOL Satisfaction with Social Roles and Activities is a health-related quality of life assessment tool. Eight items are rated on a 5-point Likert scale. Scores were converted to T-scores (mean = 50; SD = 10). Lower T-scores indicate greater dissatisfaction. | 14 weeks |
| Functional Impairment From Baseline as Measured by the Sheehan Disability Scale | The Sheehan Disability Scale is a brief self-report measure of functional impairment across three primary life domains: work/school, social life, and family life/home responsibilities. Participants rated how much their symptoms bothered or distress them over the past week on a scale from 0 (not at all) to 10 (extremely), with higher scores indicating greater functional impairment. Total scores (possible range 0-30) were used in analyses. | 0 weeks |
| Functional Impairment at 14 Weeks as Measured by the Sheehan Disability Scale | The Sheehan Disability Scale is a brief self-report measure of functional impairment across three primary life domains: work/school, social life, and family life/home responsibilities. Participants rated how much their symptoms bothered or distress them over the past week on a scale from 0 (not at all) to 10 (extremely), with higher scores indicating greater functional impairment. Total scores (possible range 0-30) were used in analyses. | 14 weeks |
| Seattle |
| Washington |
| 98108 |
| United States |
| BG001 | Treatment as Usual (TAU) | Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Years of Education | Mean | Standard Deviation | years |
|
| Branch of Military Service | Count of Participants | Participants |
|
| Occupation Status | Count of Participants | Participants |
|
| Service Connection | Count of Participants | Participants |
|
| Number of Deployments | Mean | Standard Deviation | number of deployments |
|
CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. Cognitively Augmented Behavioral Activation: CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals. |
| OG001 | Treatment as Usual (TAU) | Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need. |
|
|
| Primary | PTSD Symptoms at 14 Weeks as Measured by the Clinician Administered PTSD Scale - 5 | The Clinician Administered PTSD Scale (CAPS-IV; Blake et al., 1995; Weathers, Keane, & Davidson, 2001) was used to assess initial PTSD diagnosis (DSM-IV; APA, 2000) and PTSD symptom severity across assessment time points. The CAPS is considered a "gold standard" for assessing PTSD. Items are ranked on Likert scales according to both frequency (0-4) and intensity of symptoms (0-4), yielding an overall severity score based on the sum of frequency and intensity ratings across 17 items (range 0-136) . For this study, a diagnosis of PTSD was based on a scoring rule for items to be considered present of at least a "1" on frequency and "2" on intensity, with an overall severity score of at least 45 (Weathers, Ruscio, & Keane, 1999). | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | score on a scale | 14 weeks |
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| Primary | PTSD Symptoms From Baseline as Measured by the PTSD Checklist-5 | The Posttraumatic Stress Disorder Checklist-Fifth Edition (PCL-5; Blanchard, Jones-Alexander, Buckley, & Forneris, 1996; Weathers, Litz, Herman, Huska, & Keane, 1993; Weathers et al., 2013) was used to assess participants subjective PTSD related distress. The PCL-5 is a 20 item self-report measure that assesses the presence of DSM-5 PTSD symptoms. Items are rated on a 5-point Likert scale ranging from 0 to 4 according to how much the symptom bothered the respondent over the past month. Total scores with scores range from 0-80, with higher scores indicating more symptomatic distress. Scores totaling 31 or more are associated with presumptive PTSD among military populations. | The total number of participants analyzed at baseline. | Posted | Mean | Standard Deviation | score on a scale | 0 weeks |
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| Primary | PTSD Symptoms at 14 Weeks as Measured by the PTSD Checklist-5 | The Posttraumatic Stress Disorder Checklist-Fifth Edition (PCL-5; Blanchard, Jones-Alexander, Buckley, & Forneris, 1996; Weathers, Litz, Herman, Huska, & Keane, 1993; Weathers et al., 2013) was used to assess participants subjective PTSD related distress. The PCL-5 is a 20 item self-report measure that assesses the presence of DSM-5 PTSD symptoms. Items are rated on a 5-point Likert scale ranging from 0 to 4 according to how much the symptom bothered the respondent over the past month. Total scores with scores range from 0-80, with higher scores indicating more symptomatic distress. Scores totaling 31 or more are associated with presumptive PTSD among military populations. | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | score on a scale | 14 weeks |
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| Primary | Baseline Memory as Measured by the Hopkins Verbal Memory Test - Revised | The Hopkins Verbal Memory Test-Revised (HVLT-R; Brandt, 1991) is a measure of uncontextualized verbal learning and delayed recall. This score is converted to a standardized T-score (mean =50, S =10). The lower the T-score, the worse the performance. | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | T-score | 0 weeks |
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| Primary | Memory at 14 Weeks as Measured by the Hopkins Verbal Memory Test - Revised | The Hopkins Verbal Memory Test-Revised (HVLT-R; Brandt, 1991) is a measure of uncontextualized verbal learning and delayed recall. This score is converted to a standardized T-score (mean =50, S =10). The lower the T-score, the worse the performance. | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | T-score | 14 weeks |
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| Primary | Attention and Working Memory From Baseline as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest | The Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtest (WAIS-IV; Wechsler, D., 2008) is a measure of attention and working memory. A higher total score indicates a higher level of performance (range 0-48). Raw scores are converted to scaled scores (e.g., 1-20), with higher scaled scores indicating a higher level of performance. | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | scaled score | 0 weeks |
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| Primary | Attention and Working Memory at 14 Weeks as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest | The Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtest (WAIS-IV; Wechsler, D., 2008) is a measure of attention and working memory. A higher total score indicates a higher level of performance (range 0-48). Raw scores are converted to scaled scores (e.g., 1-20), with higher scaled scores indicating a higher level of performance. | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | scaled score | 14 weeks |
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| Primary | Verbal Fluency From Baseline as Measured by the Controlled Oral Word Association Test | The Controlled Oral Word Association Test (COWAT; Ruff et al., 1996; Spreen, 1998) is a commonly used phonemic and semantic fluency word production test. A higher score indicates a higher level of performance (range 0-patient maximum). | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | raw score | 0 weeks |
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| Primary | Verbal Fluency at 14 Weeks as Measured by the Controlled Oral Word Association Test | The Controlled Oral Word Association Test (COWAT; Ruff et al., 1996; Spreen, 1998) is a commonly used phonemic and semantic fluency word production test. A higher score indicates a higher level of performance (range 0-patient maximum). | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | raw score | 14 weeks |
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| Primary | Delis-Kaplan Executive Functions Scale (DKEFS) - Trails Subtest at Baseline | The Delis-Kaplan Executive Function System, Trail Making subtest (D-KEFS; Delis, Kaplan, & Kramer, 2001; Delis, Kramer, Kaplan, & Holdnack, 2004) is a visual-motor task used to measure flexibility in thinking (executive function) and processing speed. Raw scores are converted to scaled scores (e.g., 1-20). A higher score indicates a higher level of performance. This scale is measuring Trial 4. | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | scaled score | 0 weeks |
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| Primary | Processing Speed at 14 Weeks as Measured by Delis-Kaplan Executive Functions Scale (DKEFS) Trails Subtest | The Delis-Kaplan Executive Function System, Trail Making subtest (D-KEFS; Delis, Kaplan, & Kramer, 2001; Delis, Kramer, Kaplan, & Holdnack, 2004) is a visual-motor task used to measure flexibility in thinking (executive function) and processing speed. Raw scores are converted to scaled scores (e.g., 1-20). A higher score indicates a higher level of performance. This scale is measuring Trial 4. | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | scaled score | 14 weeks |
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| Secondary | Symptoms of Depression From Baseline as Measured by the Beck Depression Inventory -II | The Beck Depression Inventory-II (BDI-II; Beck, Steer, & Brown, 1996) is a 21-item measure of subjective levels of depression. Items are rated on a 3-point Likert scale with higher scores reflecting greater severity of symptoms (range 0-63). | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | raw score | 0 weeks |
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| Secondary | Symptoms of Depression at 14 Weeks as Measured by the Beck Depression Inventory -II | The Beck Depression Inventory-II (BDI-II; Beck, Steer, & Brown, 1996) is a 21-item measure of subjective levels of depression. Items are rated on a 3-point Likert scale with higher scores reflecting greater severity of symptoms (range 0-63). | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | raw score | 14 weeks |
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| Secondary | Global Life Satisfaction From Baseline as Measured by the Satisfaction With Life Scale | The Satisfaction with Life Scale (SWLS; Diener, Emmons, Larsen, & Griffin, 1985) is a brief measure of global life satisfaction or quality of life. Items are rated on a 7-point Likert scale with higher scores indicating greater satisfaction (range 5-35). | The total number of participants analyzed at baseline. | Posted | Mean | Standard Deviation | raw score | 0 weeks |
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| Secondary | Global Life Satisfaction at 14 Weeks as Measured by the Satisfaction With Life Scale | The Satisfaction with Life Scale (SWLS; Diener, Emmons, Larsen, & Griffin, 1985) is a brief measure of global life satisfaction or quality of life. Items are rated on a 7-point Likert scale with higher scores indicating greater satisfaction (range 5-35). | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | raw score | 14 weeks |
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| Secondary | Postconcussion Symptoms From Baseline as Measured by the Neurobehavioral Symptom Inventory | The Neurobehavioral Symptom Inventory (NSI; Cicerone, K.D. & Kalmer, K., 1995) is a post-concussive symptom measure recommended for use in military studies. Items are rated on a 4-point Likert scale with higher scores reflecting greater severity of symptom disturbance since time of injury (range 0-66). | The total number of participants analyzed at baseline. | Posted | Mean | Standard Deviation | raw score | 0 weeks |
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| Secondary | Postconcussion Symptoms at 14 Weeks as Measured by the Neurobehavioral Symptom Inventory | The Neurobehavioral Symptom Inventory (NSI; Cicerone, K.D. & Kalmer, K., 1995) is a post-concussive symptom measure recommended for use in military studies. Items are rated on a 4-point Likert scale with higher scores reflecting greater severity of symptom disturbance since time of injury (range 0-66). | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | raw score | 14 weeks |
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| Secondary | Client Satisfaction Questionnaire (CSQ) | The CSQ is an 8-item questionnaire rated on a Likert scale of 1-4 used to assess client's treatment satisfaction. Scores range from 8-32, with higher scores equaling greater satisfaction. | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | raw score | 14 weeks |
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| Other Pre-specified | Use of Cognitive Strategies From Baseline as Measured by the Memory Compensation Questionnaire | Memory Compensation Questionnaire (MCQ)70. Rates the extent to which patients use various strategies to improve memory performance. 44 Items are rated on a 5-point Likert scale with higher scores indicating grater use of compensatory strategies (range 0-176). | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | raw score | 0 weeks |
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| Other Pre-specified | Use of Cognitive Strategies at 14 Weeks as Measured by the Memory Compensation Questionnaire | Memory Compensation Questionnaire (MCQ)70. Rates the extent to which patients use various strategies to improve memory performance. 44 Items are rated on a 5-point Likert scale with higher scores indicating grater use of compensatory strategies (range 0-176). | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | raw score | 14 weeks |
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| Other Pre-specified | Postconcussion Symptoms From Baseline as Measured by the Rivermead Postconcussive Questionnaire | Rivermead Post Concussive Symptom Questionnaire (RPQ) will be used to measure postconcussive symptoms. Items are rated on a 5-point Likert scale with a higher number indicating more severe PCS (range 0-64). | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | raw score | 0 weeks |
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| Other Pre-specified | Postconcussion Symptoms at 14 Weeks as Measured by the Rivermead Postconcussive Questionnaire | Rivermead Post Concussive Symptom Questionnaire (RPQ) will be used to measure postconcussive symptoms. Items are rated on a 5-point Likert scale with a higher number indicating more severe PCS (range 0-64). | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | raw score | 14 weeks |
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| Other Pre-specified | Symptoms of Anxiety From Baseline as Measured by the Brief Symptom Inventory | Brief Symptom Inventory 18 (BSI 18) is a measure of anxiety symptoms. 18 items are rated on a 5-point Likert scale with higher scores indicating more severe symptoms (range 0-72). | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | raw score | 0 weeks |
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| Other Pre-specified | Symptoms of Anxiety at 14 Weeks as Measured by the Brief Symptom Inventory | Brief Symptom Inventory 18 (BSI 18) is a measure of anxiety symptoms. 18 items are rated on a 5-point Likert scale with higher scores indicating more severe symptoms (range 0-72). | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | raw score | 14 weeks |
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| Other Pre-specified | Health Related Quality of Life From Baseline as Measured by the Neuro-Quality of Life Satisfaction With Social Roles and Activities. | Neuro-QOL Satisfaction with Social Roles and Activities is a health-related quality of life assessment tool. Eight items are rated on a 5-point Likert scale. Scores were converted to T-scores (mean = 50; SD = 10). Lower T-scores indicate greater dissatisfaction. | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | T-score | 0 weeks |
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| Other Pre-specified | Health Related Quality of Life at 14 Weeks as Measured by the Neuro-Quality of Life Satisfaction With Social Roles and Activities. | Neuro-QOL Satisfaction with Social Roles and Activities is a health-related quality of life assessment tool. Eight items are rated on a 5-point Likert scale. Scores were converted to T-scores (mean = 50; SD = 10). Lower T-scores indicate greater dissatisfaction. | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | T-score | 14 weeks |
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| Other Pre-specified | Functional Impairment From Baseline as Measured by the Sheehan Disability Scale | The Sheehan Disability Scale is a brief self-report measure of functional impairment across three primary life domains: work/school, social life, and family life/home responsibilities. Participants rated how much their symptoms bothered or distress them over the past week on a scale from 0 (not at all) to 10 (extremely), with higher scores indicating greater functional impairment. Total scores (possible range 0-30) were used in analyses. | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | raw score | 0 weeks |
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| Other Pre-specified | Functional Impairment at 14 Weeks as Measured by the Sheehan Disability Scale | The Sheehan Disability Scale is a brief self-report measure of functional impairment across three primary life domains: work/school, social life, and family life/home responsibilities. Participants rated how much their symptoms bothered or distress them over the past week on a scale from 0 (not at all) to 10 (extremely), with higher scores indicating greater functional impairment. Total scores (possible range 0-30) were used in analyses. | The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data. | Posted | Mean | Standard Deviation | raw score | 14 weeks |
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| 0 |
| 39 |
| 1 |
| 39 |
| 3 |
| 39 |
| EG001 | Treatment as Usual (TAU) | Treatment as Usual (TAU) is the usual care that patients would normally receive at the VA. TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients. TAU may also include additional evaluation and/or treatment of mTBI. Treatment for mTBI includes individual or group sessions, and is based on clinical need. Treatment as Usual: TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to "process" his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need. | 0 | 34 | 0 | 34 | 3 | 34 |
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| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment | Participant taken to ED due to SI with vague plan. |
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| Emergency Department Visit | General disorders | Non-systematic Assessment | injury/pain |
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Not provided
Not provided
Not provided
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |