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| ID | Type | Description | Link |
|---|---|---|---|
| 1IK2RX002762-01A1 | U.S. NIH Grant/Contract | View source |
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Approximately half a million Veterans receiving services at the VA have Posttraumatic Stress Disorder (PTSD). PTSD is strongly associated with cognitive functioning deficits in areas of concentration, attention, memory, learning, verbal abilities, processing speed, and multitasking. Compensatory Cognitive Training (CCT) is an evidence-based intervention for cognitive problems that is effective in other Veteran populations such as those with a history of traumatic brain injury (TBI), but CCT has not yet been tested in Veterans with PTSD who don't have a history of TBI. The investigators will conduct a pilot randomized controlled trial (RCT) of CCT in Veterans who have been treated for PTSD but continue to have cognitive functioning deficits. The investigators will examine feasibility, acceptability, participant characteristics, and effect size estimates in preparation for a fully-powered RCT of CCT for PTSD-related cognitive functioning deficits.
Project Background: PTSD is associated with deficits in cognitive functioning including memory, learning, processing speed, concentration, attention, and executive functioning. Though many Veterans benefit from evidence-based psychotherapy (EBP) for PTSD, many Veterans have cognitive functioning deficits even after completing EBP for PTSD. There are no evidence-based treatments for these Veterans. Compensatory Cognitive Training (CCT) is improves cognitive functioning in Veterans with brain injury history, but is not yet tested in Veterans with PTSD.
Project Aims: This study will evaluate feasibility, acceptability, and participant characteristics, and estimate effect sizes, in a pilot test of CCT for Veterans with PTSD-related cognitive problems. Data from this study will form the basis for a future, fully powered trial testing the effectiveness of CCT for cognitive problems in Veterans with PTSD.
Project Methods: The investigators will recruit Veterans from local VA mental health clinics, using the VA's Corporate Data Warehouse (CDW) to identify potentially eligible Veterans if needed. The investigators will compare CCT vs. treatment as usual for 36 Veterans with PTSD-related cognitive functioning deficits. The investigators will calculate rates of recruitment, retention, and intervention participation. Statistical significance will be examined, though the investigators' focus will be on effect size estimates, score ranges, and variability to plan for a follow-up, fully powered RCT.
Anticipated Impact: PTSD-related cognitive functioning deficits are a significant problem for many Veterans. CCT is an effective cognitive rehabilitation intervention for Veterans with a history of brain injury, but VA clinicians need data on its effectiveness for Veterans with PTSD-related cognitive functioning deficits. These studies will provide the data necessary for a larger scale RCT proposal if results show that CCT is as promising as expected for Veterans with PTSD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compensatory Cognitive Training (CCT) | Experimental | Compensatory Cognitive Training draws from the theoretical literature on compensatory strategy training for other cognitively impaired populations (e.g., Huckans et al., 2013; Twamley et al., 2010; Storzbach et al., 2016). It is a rehabilitation model that aims to teach individuals strategies that allow them to work around cognitive deficits. Consistent with this model and the expert recommendations for civilians and Service members with TBI (Cicerone, 2011), manualized CCT treatment provides training in compensatory attention and learning/memory skills, formal problem-solving strategies applied to daily problems, and the use of external aids such as calendar systems and assistive devices to promote completion of daily tasks (Storzbach et al., 2016). |
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| Treatment as Usual (TAU) | Active Comparator | All TAU participants have an ongoing VA mental health provider and received ongoing mental health care during the course of the study (generally weekly individual or group sessions focusing on evidence-based PTSD treatment). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compensatory Cognitive Training (CCT) | Behavioral | Compensatory Cognitive Training draws from the theoretical literature on compensatory strategy training for other cognitively impaired populations (e.g., Huckans et al., 2013; Twamley et al., 2010; Storzbach et al., 2016). It is a rehabilitation model that aims to teach individuals strategies that allow them to work around cognitive deficits. Consistent with this model and the expert recommendations for civilians and Service members with TBI (Cicerone, 2011), manualized CCT treatment provides training in compensatory attention and learning/memory skills, formal problem-solving strategies applied to daily problems, and the use of external aids such as calendar systems and assistive devices to promote completion of daily tasks (Storzbach et al., 2016). |
| Measure | Description | Time Frame |
|---|---|---|
| Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford et al., 2006) | Self-report severity measure of prospective (remembering to do something in the future) and retrospective (remembering something from the past) memory problems relevant to every day life. Higher scores represent worse outcomes. Total score ranges from 0-64. | change from baseline to 3 and 6 months |
| Multiple Sclerosis Neuropsychological Screening Questionnaire - Patient Version (MSNQ; Benedict et al., 2003) | Self-report severity measure of attention and organizational problems. Scores on the MSNQ range from 0 to 58, with higher scores indicating greater cognitive impairment. | change from baseline to 3 and 6 months |
| California Verbal Learning Test (CVLT-II; Delis et al., 2000) | Comprehensive measurement of verbal learning and memory and includes a forced choice validity. The total raw score is the sum of correct responses on the five presentations; scores range from 0-80. Higher scores represent better outcomes. | change from baseline to 3 and 6 months |
| Wechsler Adult Intelligence Scale (WAIS-IV) Coding Subtest (Wechsler, 2008) | A measure of processing speed. Higher scores represent better outcomes. Scores range from 0-155. | change from baseline to 3 and 6 months |
| Controlled Oral Word Association Test (Benton, Hamsher, & Sivan, 1983) | The Controlled Oral Word Association (COWA) Test measures word generation, verbal fluency, and executive functioning. Participants are asked to name as many words as they can starting with a specific letter (i.e., F, A, S) within one minute, and as many words as possible in a specified category (i.e., animals) within one minute. Total score is the sum of responses (three letter trials, one category trial). Higher scores represent better outcomes. Total score ranges are affected by age and education. |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Checklist (PCL-5; Weathers et al., 2013) | PTSD symptoms and severity. Higher scores indicates more severe symptomology. Total score ranges from 0-80. | change from baseline to 3 and 6 months |
| Patient Health Questionnaire (PHQ-9; Spitzer, Kroenke, & Williams, 1999) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maya Elin O'Neil, PhD MS | 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 | 97207-2964 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Compensatory Cognitive Training (CCT) | Compensatory Cognitive Training (CCT): Compensatory Cognitive Training draws from the theoretical literature on compensatory strategy training for other cognitively impaired populations (e.g., Huckans et al., 2013; Twamley et al., 2010; Storzbach et al., 2016). It is a rehabilitation model that aims to teach individuals strategies that allow them to work around cognitive deficits. Consistent with this model and the expert recommendations for civilians and Service members with TBI (Cicerone, 2011), manualized CCT treatment provides training in compensatory attention and learning/memory skills, formal problem-solving strategies applied to daily problems, and the use of external aids such as calendar systems and assistive devices to promote completion of daily tasks (Storzbach et al., 2016). |
| FG001 | Treatment as Usual (TAU) | Treatment as Usual (TAU): All TAU participants have an ongoing VA mental health provider and received ongoing mental health care during the course of the study (generally weekly individual or group sessions focusing on evidence-based PTSD treatment). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Compensatory Cognitive Training (CCT) | Compensatory Cognitive Training draws from the theoretical literature on compensatory strategy training for other cognitively impaired populations (e.g., Huckans et al., 2013; Twamley et al., 2010; Storzbach et al., 2016). It is a rehabilitation model that aims to teach individuals strategies that allow them to work around cognitive deficits. Consistent with this model and the expert recommendations for civilians and Service members with TBI (Cicerone, 2011), manualized CCT treatment provides training in compensatory attention and learning/memory skills, formal problem-solving strategies applied to daily problems, and the use of external aids such as calendar systems and assistive devices to promote completion of daily tasks (Storzbach et al., 2016). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford et al., 2006) | Self-report severity measure of prospective (remembering to do something in the future) and retrospective (remembering something from the past) memory problems relevant to every day life. Higher scores represent worse outcomes. Total score ranges from 0-64. | Due to drop-out and COVID precautions, there were less participants who completed measures at 3- and 6-Month follow-ups | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 3 and 6 months |
|
6 Months
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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 | Compensatory Cognitive Training (CCT) | Compensatory Cognitive Training draws from the theoretical literature on compensatory strategy training for other cognitively impaired populations (e.g., Huckans et al., 2013; Twamley et al., 2010; Storzbach et al., 2016). It is a rehabilitation model that aims to teach individuals strategies that allow them to work around cognitive deficits. Consistent with this model and the expert recommendations for civilians and Service members with TBI (Cicerone, 2011), manualized CCT treatment provides training in compensatory attention and learning/memory skills, formal problem-solving strategies applied to daily problems, and the use of external aids such as calendar systems and assistive devices to promote completion of daily tasks (Storzbach et al., 2016). |
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Coronavirus disease shutdown resulted in less recruitment than initially anticipated. Groups and assessments were moved to a remote, phone-based format which may have limited understanding and application of skills taught in groups. Exclusion criteria included some diagnoses (i.e., history of TBI) which are frequently comorbid with PTSD, which limited the sample and affected recruitment efforts. Low demographic variability limits representation and generalizability to the larger population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maya E. O'Neil, Principal Investigator | VA Portland Health Care System | 503-220-8262 | 54522 | Maya.Oneil@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 | Feb 2, 2024 | Aug 13, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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This is a parallel randomized controlled pilot trial.
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Assessors will be masked to participant condition.
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| Treatment as Usual (TAU) | Behavioral | All TAU participants have an ongoing VA mental health provider and received ongoing mental health care during the course of the study (generally weekly individual or group sessions focusing on evidence-based PTSD treatment). |
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| change from baseline to 3 and 6 months |
| Halstead Reitan Trailmaking Test (Trails A & B; Reitan & Wolfson, 1985) | Measures visual tracking, processing speed, and executive functioning. Scores represent the amount of time to complete the task (in seconds), range from 10-366, and higher numbers represent worse outcomes. | change from baseline to 3 and 6 months |
| World Health Organization Disability Assessment Scale (WHODAS 2.0) | Self-report measure of quality of life and global functioning. Higher scores represent worse outcomes. Total score ranges from 0-144. | change from baseline to 3 and 6 months |
| Quality of Life in Neurological Disorders (Neuro-QOL): Cognitive, Ability to Participate in Social Roles and Activities, and Sleep Scales | Self-report measure of quality of life, cognitive functioning, sleep functioning, and social functioning. Higher scores represent lower functioning. Total scores range from 52 to 260. | change from baseline to 3 and 6 months |
| Memory Compensation Questionnaire (MCQ; de Frias & Dixon, 2005) | A 44-item self-report questionnaire that rates the extent of use of various strategies to improve memory performance relevant to daily living. Higher scores represent better outcomes. Total score ranges from 0-176. | change from baseline to 3 and 6 months |
| Portland Cognitive Strategies Scale 2.0 (PCSS) | Measures compensatory cognitive strategy use through two scales; how often skills are used and how useful. Higher scores represent more skill use and more perceived usefulness. Total score ranges from 0-60 per scale. | change from baseline to 3 and 6 months |
| Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span Subtest (Wechsler, 2008) | Measures attention, working memory, processing speed, and reliable digit span validity. Higher scores represent better outcomes. Scores on each subtest (forward, backward, and sequential) range from 0-16 and are reported as WAIS Scaled Scores. Total score (range 0-48) is the sum of each subtest. | change from baseline to 3 and 6 months |
A brief, nine-item depression assessment questionnaire used to screen for depression and monitor its severity. Higher scores represent worse outcomes. Total score ranges from 0-27. |
| change from baseline to 3 and 6 months |
| BG001 | Treatment as Usual (TAU) | All TAU participants have an ongoing VA mental health provider and received ongoing mental health care during the course of the study (generally weekly individual or group sessions focusing on evidence-based PTSD treatment). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Education (years) | Mean | Standard Deviation | years |
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| Mental Health Diagnosis | Count of Participants | Participants |
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| OG001 | Treatment as Usual (TAU) | Treatment as Usual (TAU): All TAU participants have an ongoing VA mental health provider and received ongoing mental health care during the course of the study (generally weekly individual or group sessions focusing on evidence-based PTSD treatment). |
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| Primary | Multiple Sclerosis Neuropsychological Screening Questionnaire - Patient Version (MSNQ; Benedict et al., 2003) | Self-report severity measure of attention and organizational problems. Scores on the MSNQ range from 0 to 58, with higher scores indicating greater cognitive impairment. | Due to drop-out and COVID precautions, there were less participants who completed measures at 3- and 6-Month follow-ups | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 3 and 6 months |
|
|
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| Primary | California Verbal Learning Test (CVLT-II; Delis et al., 2000) | Comprehensive measurement of verbal learning and memory and includes a forced choice validity. The total raw score is the sum of correct responses on the five presentations; scores range from 0-80. Higher scores represent better outcomes. | Due to drop-out and COVID precautions, there were less participants who completed measures at 3- and 6-Month follow-ups | Posted | Mean | Standard Deviation | score on a measure | change from baseline to 3 and 6 months |
|
|
|
| Primary | Wechsler Adult Intelligence Scale (WAIS-IV) Coding Subtest (Wechsler, 2008) | A measure of processing speed. Higher scores represent better outcomes. Scores range from 0-155. | Due to drop-out and COVID precautions, there were less participants who completed measures at 3- and 6-Month follow-ups | Posted | Mean | Standard Deviation | score on a measure | change from baseline to 3 and 6 months |
|
|
|
| Primary | Controlled Oral Word Association Test (Benton, Hamsher, & Sivan, 1983) | The Controlled Oral Word Association (COWA) Test measures word generation, verbal fluency, and executive functioning. Participants are asked to name as many words as they can starting with a specific letter (i.e., F, A, S) within one minute, and as many words as possible in a specified category (i.e., animals) within one minute. Total score is the sum of responses (three letter trials, one category trial). Higher scores represent better outcomes. Total score ranges are affected by age and education. | Due to drop-out and COVID precautions, there were less participants who completed measures at 3- and 6-Month follow-ups | Posted | Mean | Standard Deviation | Number of words | change from baseline to 3 and 6 months |
|
|
|
| Primary | Halstead Reitan Trailmaking Test (Trails A & B; Reitan & Wolfson, 1985) | Measures visual tracking, processing speed, and executive functioning. Scores represent the amount of time to complete the task (in seconds), range from 10-366, and higher numbers represent worse outcomes. | Due to drop-out and COVID precautions, there were less participants who completed measures at 3- and 6-Month follow-ups | Posted | Mean | Standard Deviation | Seconds | change from baseline to 3 and 6 months |
|
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| Primary | World Health Organization Disability Assessment Scale (WHODAS 2.0) | Self-report measure of quality of life and global functioning. Higher scores represent worse outcomes. Total score ranges from 0-144. | Due to drop-out and COVID precautions, there were less participants who completed measures at 3- and 6-Month follow-ups | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 3 and 6 months |
|
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| Primary | Quality of Life in Neurological Disorders (Neuro-QOL): Cognitive, Ability to Participate in Social Roles and Activities, and Sleep Scales | Self-report measure of quality of life, cognitive functioning, sleep functioning, and social functioning. Higher scores represent lower functioning. Total scores range from 52 to 260. | Due to drop-out and COVID precautions, there were less participants who completed measures at 3- and 6-Month follow-ups | Posted | Mean | Standard Deviation | scores on a scale | change from baseline to 3 and 6 months |
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| Primary | Memory Compensation Questionnaire (MCQ; de Frias & Dixon, 2005) | A 44-item self-report questionnaire that rates the extent of use of various strategies to improve memory performance relevant to daily living. Higher scores represent better outcomes. Total score ranges from 0-176. | Due to drop-out and COVID precautions, there were less participants who completed measures at 3- and 6-Month follow-ups | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 3 and 6 months |
|
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| Primary | Portland Cognitive Strategies Scale 2.0 (PCSS) | Measures compensatory cognitive strategy use through two scales; how often skills are used and how useful. Higher scores represent more skill use and more perceived usefulness. Total score ranges from 0-60 per scale. | Due to drop-out and COVID precautions, there were less participants who completed measures at 3- and 6-Month follow-ups | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 3 and 6 months |
|
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| Primary | Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span Subtest (Wechsler, 2008) | Measures attention, working memory, processing speed, and reliable digit span validity. Higher scores represent better outcomes. Scores on each subtest (forward, backward, and sequential) range from 0-16 and are reported as WAIS Scaled Scores. Total score (range 0-48) is the sum of each subtest. | Due to drop-out and COVID precautions, there were less participants who completed measures at 3- and 6-Month follow-ups | Posted | Mean | Standard Deviation | score on a measure | change from baseline to 3 and 6 months |
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| Secondary | PTSD Checklist (PCL-5; Weathers et al., 2013) | PTSD symptoms and severity. Higher scores indicates more severe symptomology. Total score ranges from 0-80. | Due to drop-out and COVID precautions, there were less participants who completed measures at 3- and 6-Month follow-ups | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 3 and 6 months |
|
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| Secondary | Patient Health Questionnaire (PHQ-9; Spitzer, Kroenke, & Williams, 1999) | A brief, nine-item depression assessment questionnaire used to screen for depression and monitor its severity. Higher scores represent worse outcomes. Total score ranges from 0-27. | Due to drop-out and COVID precautions, there were less participants who completed measures at 3- and 6-Month follow-ups | Posted | Mean | Standard Deviation | Score on a scale | change from baseline to 3 and 6 months |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Treatment as Usual (TAU) | All TAU participants have an ongoing VA mental health provider and received ongoing mental health care during the course of the study (generally weekly individual or group sessions focusing on evidence-based PTSD treatment). | 0 | 8 | 0 | 8 | 0 | 13 |
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