Posttraumatic Stress Disorder, Traumatic Brain Injury
Conditions
Keywords
Brain injury, TBI, PTSD, Polytrauma
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCognitively 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.
BEHAVIORALTreatment 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Veterans 55 years of age enrolled at participating VA sites able to provide informed consent. * Diagnosis of PTSD based on the Clinician Administered PTSD Scale. * Positive screen on the Structured Interview for Collecting Head Trauma Event Characteristics as per the VA/Department of Defense (DoD) Clinical Practice Guideline for Management of Concussion/mTBI; AND endorsed any of the Neurobehavioral Symptom Inventory (NSI) cognitive symptoms items (items 13-17). * English speaking, able to travel to the primary care clinics weekly for 10 sessions and for the follow-up assessments, and willing to refrain from the initiation of additional mental health treatment during the first 3 1/2 months of the active phase of treatment if they are assigned to the CABA condition. * Willingness to participate in audio-recorded sessions. (for treatment adherence)
Exclusion criteria
* Current diagnosis of moderate or severe substance (alcohol) use disorder using DSM-5 criteria within the past 30 days. * Individuals with other psychiatric diagnoses will not be excluded except for bipolar disorder and psychotic disorders (requirement to refrain from additional treatments might be harmful). * Veterans with a history indicated by medical record review of a diagnosis of moderate, severe, or penetrating TBI, or self-reported history on the Structured Interview for Collecting Head Trauma Event Characteristics of TBI with Post-Traumatic Amnesia (PTA) greater than 24 hours or loss of consciousness (LOC) greater than 30 minutes. * Active suicidal intent indicating significant clinical risk, which would suggest that a treatment specifically targeting this intent was indicated. Clients who report suicidal ideation without imminent risk will be admitted into the study. * Initiated psychotropic medication, including Prazosin, within 4 weeks or changed dosage within 2 weeks prior to the first assessment, as this would make it difficult to determine which treatment contributed to change in the CABA condition; additionally, started or changed dosage of sleep medication or low dosages of tricyclic antidepressant or trazodone for pain or sleep within 1 week prior to the first assessment. Participants could be reconsidered for eligibility after stability on medication was achieved. Enrollees will be asked to hold the doses of the current medications stable over the course of enrollment (though changes in medications after enrollment will not exclude them from on-going participation). * Auditory or visual impairments that would compromise ability to participate or benefit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Fluency at 14 Weeks as Measured by the Controlled Oral Word Association Test | 14 weeks | 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). |
| Verbal Fluency From Baseline as Measured by the Controlled Oral Word Association Test | 0 weeks | 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). |
| PTSD Symptoms From Baseline as Measured by the PTSD Checklist-5 | 0 weeks | 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. |
| Attention and Working Memory at 14 Weeks as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest | 14 weeks | 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. |
| Attention and Working Memory From Baseline as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest | 0 weeks | 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. |
| PTSD Symptoms From Baseline as Measured by the Clinician Administered PTSD Scale - 5 | 0 weeks | 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). |
| PTSD Symptoms at 14 Weeks as Measured by the Clinician Administered PTSD Scale - 5 | 14 weeks | 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). |
| Memory at 14 Weeks as Measured by the Hopkins Verbal Memory Test - Revised | 14 weeks | 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. |
| Baseline Memory as Measured by the Hopkins Verbal Memory Test - Revised | 0 weeks | 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. |
| PTSD Symptoms at 14 Weeks as Measured by the PTSD Checklist-5 | 14 weeks | 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. |
| Processing Speed at 14 Weeks as Measured by Delis-Kaplan Executive Functions Scale (DKEFS) Trails Subtest | 14 weeks | 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. |
| Delis-Kaplan Executive Functions Scale (DKEFS) - Trails Subtest at Baseline | 0 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postconcussion Symptoms From Baseline as Measured by the Neurobehavioral Symptom Inventory | 0 weeks | 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). |
| Symptoms of Depression From Baseline as Measured by the Beck Depression Inventory -II | 0 weeks | 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). |
| Symptoms of Depression at 14 Weeks as Measured by the Beck Depression Inventory -II | 14 weeks | 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). |
| Global Life Satisfaction From Baseline as Measured by the Satisfaction With Life Scale | 0 weeks | 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). |
| Global Life Satisfaction at 14 Weeks as Measured by the Satisfaction With Life Scale | 14 weeks | 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). |
| Postconcussion Symptoms at 14 Weeks as Measured by the Neurobehavioral Symptom Inventory | 14 weeks | 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). |
| Client Satisfaction Questionnaire (CSQ) | 14 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Use of Cognitive Strategies From Baseline as Measured by the Memory Compensation Questionnaire | 0 weeks | 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). |
| Functional Impairment at 14 Weeks as Measured by the Sheehan Disability Scale | 14 weeks | 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. |
| Functional Impairment From Baseline as Measured by the Sheehan Disability Scale | 0 weeks | 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. |
| Health Related Quality of Life at 14 Weeks as Measured by the Neuro-Quality of Life Satisfaction With Social Roles and Activities. | 14 weeks | 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. |
| Health Related Quality of Life From Baseline as Measured by the Neuro-Quality of Life Satisfaction With Social Roles and Activities. | 0 weeks | 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. |
| Symptoms of Anxiety at 14 Weeks as Measured by the Brief Symptom Inventory | 14 weeks | 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). |
| Symptoms of Anxiety From Baseline as Measured by the Brief Symptom Inventory | 0 weeks | 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). |
| Postconcussion Symptoms at 14 Weeks as Measured by the Rivermead Postconcussive Questionnaire | 14 weeks | 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). |
| Postconcussion Symptoms From Baseline as Measured by the Rivermead Postconcussive Questionnaire | 0 weeks | 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). |
| Use of Cognitive Strategies at 14 Weeks as Measured by the Memory Compensation Questionnaire | 14 weeks | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 39 |
| 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. | 34 |
| Total | 73 |
Baseline characteristics
| Characteristic | Total | Treatment as Usual (TAU) | CABA |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 73 Participants | 34 Participants | 39 Participants |
| Branch of Military Service Air Force | 5 Participants | 3 Participants | 2 Participants |
| Branch of Military Service Army | 42 Participants | 18 Participants | 24 Participants |
| Branch of Military Service Coast Guard | 1 Participants | 1 Participants | 0 Participants |
| Branch of Military Service Marines | 15 Participants | 6 Participants | 9 Participants |
| Branch of Military Service Navy | 8 Participants | 4 Participants | 4 Participants |
| Branch of Military Service Unreported | 2 Participants | 2 Participants | 0 Participants |
| Number of Deployments | 2.05 number of deployments STANDARD_DEVIATION 1.22 | 2.24 number of deployments STANDARD_DEVIATION 1.44 | 1.90 number of deployments STANDARD_DEVIATION 1.01 |
| Occupation Status Employed | 34 Participants | 15 Participants | 19 Participants |
| Occupation Status Unemployed | 39 Participants | 19 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) White | 54 Participants | 24 Participants | 30 Participants |
| Region of Enrollment United States | 73 Participants | 34 Participants | 39 Participants |
| Service Connection No | 60 Participants | 26 Participants | 34 Participants |
| Service Connection Unreported | 4 Participants | 3 Participants | 1 Participants |
| Service Connection Yes | 9 Participants | 5 Participants | 4 Participants |
| Sex: Female, Male Female | 13 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Male | 60 Participants | 31 Participants | 29 Participants |
| Years of Education | 14.19 years STANDARD_DEVIATION 2.22 | 13.73 years STANDARD_DEVIATION 1.99 | 14.58 years STANDARD_DEVIATION 2.34 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 34 |
| other Total, other adverse events | 3 / 39 | 3 / 34 |
| serious Total, serious adverse events | 1 / 39 | 0 / 34 |
Outcome results
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.
Time frame: 14 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Attention and Working Memory at 14 Weeks as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest | 10.46 scaled score | Standard Deviation 2.43 |
| Treatment as Usual (TAU) | Attention and Working Memory at 14 Weeks as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest | 9.40 scaled score | Standard Deviation 2.87 |
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.
Time frame: 0 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Attention and Working Memory From Baseline as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest | 8.95 scaled score | Standard Deviation 2.52 |
| Treatment as Usual (TAU) | Attention and Working Memory From Baseline as Measured by the Wechsler Adult Intelligence Scale-4th Edition, Digit Span Subtest | 9.22 scaled score | Standard Deviation 2.83 |
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.
Time frame: 0 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Baseline Memory as Measured by the Hopkins Verbal Memory Test - Revised | 35.05 T-score | Standard Deviation 11.4 |
| Treatment as Usual (TAU) | Baseline Memory as Measured by the Hopkins Verbal Memory Test - Revised | 33.74 T-score | Standard Deviation 10.84 |
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.
Time frame: 0 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Delis-Kaplan Executive Functions Scale (DKEFS) - Trails Subtest at Baseline | 9.08 scaled score | Standard Deviation 3.68 |
| Treatment as Usual (TAU) | Delis-Kaplan Executive Functions Scale (DKEFS) - Trails Subtest at Baseline | 8.30 scaled score | Standard Deviation 3.58 |
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.
Time frame: 14 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Memory at 14 Weeks as Measured by the Hopkins Verbal Memory Test - Revised | 45.33 T-score | Standard Deviation 13.58 |
| Treatment as Usual (TAU) | Memory at 14 Weeks as Measured by the Hopkins Verbal Memory Test - Revised | 37.30 T-score | Standard Deviation 13.22 |
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.
Time frame: 14 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Processing Speed at 14 Weeks as Measured by Delis-Kaplan Executive Functions Scale (DKEFS) Trails Subtest | 10.61 scaled score | Standard Deviation 3.09 |
| Treatment as Usual (TAU) | Processing Speed at 14 Weeks as Measured by Delis-Kaplan Executive Functions Scale (DKEFS) Trails Subtest | 9.79 scaled score | Standard Deviation 2.53 |
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).
Time frame: 14 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | PTSD Symptoms at 14 Weeks as Measured by the Clinician Administered PTSD Scale - 5 | 33.32 score on a scale | Standard Deviation 13.43 |
| Treatment as Usual (TAU) | PTSD Symptoms at 14 Weeks as Measured by the Clinician Administered PTSD Scale - 5 | 37.35 score on a scale | Standard Deviation 13.71 |
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.
Time frame: 14 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | PTSD Symptoms at 14 Weeks as Measured by the PTSD Checklist-5 | 44.92 score on a scale | Standard Deviation 16.45 |
| Treatment as Usual (TAU) | PTSD Symptoms at 14 Weeks as Measured by the PTSD Checklist-5 | 52.17 score on a scale | Standard Deviation 16.66 |
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).
Time frame: 0 weeks
Population: The total number of participants analyzed at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | PTSD Symptoms From Baseline as Measured by the Clinician Administered PTSD Scale - 5 | 40.62 score on a scale | Standard Deviation 10.65 |
| Treatment as Usual (TAU) | PTSD Symptoms From Baseline as Measured by the Clinician Administered PTSD Scale - 5 | 40.53 score on a scale | Standard Deviation 10.31 |
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.
Time frame: 0 weeks
Population: The total number of participants analyzed at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | PTSD Symptoms From Baseline as Measured by the PTSD Checklist-5 | 50.15 score on a scale | Standard Deviation 14.48 |
| Treatment as Usual (TAU) | PTSD Symptoms From Baseline as Measured by the PTSD Checklist-5 | 51.21 score on a scale | Standard Deviation 13.49 |
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).
Time frame: 14 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Verbal Fluency at 14 Weeks as Measured by the Controlled Oral Word Association Test | 44.92 raw score | Standard Deviation 7.52 |
| Treatment as Usual (TAU) | Verbal Fluency at 14 Weeks as Measured by the Controlled Oral Word Association Test | 41.05 raw score | Standard Deviation 11.3 |
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).
Time frame: 0 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Verbal Fluency From Baseline as Measured by the Controlled Oral Word Association Test | 43.68 raw score | Standard Deviation 8.18 |
| Treatment as Usual (TAU) | Verbal Fluency From Baseline as Measured by the Controlled Oral Word Association Test | 43.54 raw score | Standard Deviation 11.93 |
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.
Time frame: 14 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Client Satisfaction Questionnaire (CSQ) | 27.75 raw score | Standard Deviation 6.07 |
| Treatment as Usual (TAU) | Client Satisfaction Questionnaire (CSQ) | 27.24 raw score | Standard Deviation 3.29 |
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).
Time frame: 14 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Global Life Satisfaction at 14 Weeks as Measured by the Satisfaction With Life Scale | 16.92 raw score | Standard Deviation 7.39 |
| Treatment as Usual (TAU) | Global Life Satisfaction at 14 Weeks as Measured by the Satisfaction With Life Scale | 15.32 raw score | Standard Deviation 8.07 |
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).
Time frame: 0 weeks
Population: The total number of participants analyzed at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Global Life Satisfaction From Baseline as Measured by the Satisfaction With Life Scale | 15.38 raw score | Standard Deviation 6.37 |
| Treatment as Usual (TAU) | Global Life Satisfaction From Baseline as Measured by the Satisfaction With Life Scale | 15.41 raw score | Standard Deviation 7.72 |
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).
Time frame: 14 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Postconcussion Symptoms at 14 Weeks as Measured by the Neurobehavioral Symptom Inventory | 42.72 raw score | Standard Deviation 17.51 |
| Treatment as Usual (TAU) | Postconcussion Symptoms at 14 Weeks as Measured by the Neurobehavioral Symptom Inventory | 49.43 raw score | Standard Deviation 14.88 |
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).
Time frame: 0 weeks
Population: The total number of participants analyzed at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Postconcussion Symptoms From Baseline as Measured by the Neurobehavioral Symptom Inventory | 45.79 raw score | Standard Deviation 14.81 |
| Treatment as Usual (TAU) | Postconcussion Symptoms From Baseline as Measured by the Neurobehavioral Symptom Inventory | 46.38 raw score | Standard Deviation 10.96 |
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).
Time frame: 14 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Symptoms of Depression at 14 Weeks as Measured by the Beck Depression Inventory -II | 24.96 raw score | Standard Deviation 13.26 |
| Treatment as Usual (TAU) | Symptoms of Depression at 14 Weeks as Measured by the Beck Depression Inventory -II | 31.17 raw score | Standard Deviation 11.41 |
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).
Time frame: 0 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Symptoms of Depression From Baseline as Measured by the Beck Depression Inventory -II | 29.74 raw score | Standard Deviation 12.02 |
| Treatment as Usual (TAU) | Symptoms of Depression From Baseline as Measured by the Beck Depression Inventory -II | 30.10 raw score | Standard Deviation 9.62 |
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.
Time frame: 14 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Functional Impairment at 14 Weeks as Measured by the Sheehan Disability Scale | 15.57 raw score | Standard Deviation 7.77 |
| Treatment as Usual (TAU) | Functional Impairment at 14 Weeks as Measured by the Sheehan Disability Scale | 18.36 raw score | Standard Deviation 8.33 |
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.
Time frame: 0 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Functional Impairment From Baseline as Measured by the Sheehan Disability Scale | 20.06 raw score | Standard Deviation 7.43 |
| Treatment as Usual (TAU) | Functional Impairment From Baseline as Measured by the Sheehan Disability Scale | 21.50 raw score | Standard Deviation 6.06 |
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.
Time frame: 14 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Health Related Quality of Life at 14 Weeks as Measured by the Neuro-Quality of Life Satisfaction With Social Roles and Activities. | 37.90 T-score | Standard Deviation 12.82 |
| Treatment as Usual (TAU) | Health Related Quality of Life at 14 Weeks as Measured by the Neuro-Quality of Life Satisfaction With Social Roles and Activities. | 38.72 T-score | Standard Deviation 4.8 |
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.
Time frame: 0 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Health Related Quality of Life From Baseline as Measured by the Neuro-Quality of Life Satisfaction With Social Roles and Activities. | 38.37 T-score | Standard Deviation 8.06 |
| Treatment as Usual (TAU) | Health Related Quality of Life From Baseline as Measured by the Neuro-Quality of Life Satisfaction With Social Roles and Activities. | 32.38 T-score | Standard Deviation 15.41 |
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).
Time frame: 14 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Postconcussion Symptoms at 14 Weeks as Measured by the Rivermead Postconcussive Questionnaire | 35.35 raw score | Standard Deviation 15.44 |
| Treatment as Usual (TAU) | Postconcussion Symptoms at 14 Weeks as Measured by the Rivermead Postconcussive Questionnaire | 37.42 raw score | Standard Deviation 15.07 |
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).
Time frame: 0 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Postconcussion Symptoms From Baseline as Measured by the Rivermead Postconcussive Questionnaire | 40.76 raw score | Standard Deviation 12.39 |
| Treatment as Usual (TAU) | Postconcussion Symptoms From Baseline as Measured by the Rivermead Postconcussive Questionnaire | 39.45 raw score | Standard Deviation 12.03 |
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).
Time frame: 14 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Symptoms of Anxiety at 14 Weeks as Measured by the Brief Symptom Inventory | 26.54 raw score | Standard Deviation 15.49 |
| Treatment as Usual (TAU) | Symptoms of Anxiety at 14 Weeks as Measured by the Brief Symptom Inventory | 29.56 raw score | Standard Deviation 15.76 |
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).
Time frame: 0 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Symptoms of Anxiety From Baseline as Measured by the Brief Symptom Inventory | 30.87 raw score | Standard Deviation 14.33 |
| Treatment as Usual (TAU) | Symptoms of Anxiety From Baseline as Measured by the Brief Symptom Inventory | 30.91 raw score | Standard Deviation 13.72 |
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).
Time frame: 14 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Use of Cognitive Strategies at 14 Weeks as Measured by the Memory Compensation Questionnaire | 121.38 raw score | Standard Deviation 25.8 |
| Treatment as Usual (TAU) | Use of Cognitive Strategies at 14 Weeks as Measured by the Memory Compensation Questionnaire | 115.55 raw score | Standard Deviation 45.06 |
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).
Time frame: 0 weeks
Population: The total number of participants analyzed is less than the total number of study participants due to incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CABA | Use of Cognitive Strategies From Baseline as Measured by the Memory Compensation Questionnaire | 120.18 raw score | Standard Deviation 28.67 |
| Treatment as Usual (TAU) | Use of Cognitive Strategies From Baseline as Measured by the Memory Compensation Questionnaire | 120.97 raw score | Standard Deviation 28.46 |