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Many Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn era Veterans have suffered a mild traumatic brain injury (mTBI), and now cope with multiple post-injury symptoms, including sleep disturbances (especially insomnia). Chronic insomnia in mTBI patients has the potential to exacerbate other symptoms, delay recovery, and negatively affect many of the cognitive, psychological, and neuromuscular sequelae of mTBI, thereby decreasing quality of life. Although Cognitive-Behavioral Therapy for Insomnia (CBT-I) has been shown to be an effective evidence-based treatment for insomnia, there are no published randomized controlled trials evaluating the potential strengths and/or limitations of CBT-I in post-mTBI patients. Therefore, assessing CBT-I in the context of mTBI holds promise to provide substantial benefits in terms of improved rehabilitation outcomes in Veterans who have suffered mTBI.
This VA Rehabilitation Research and Development Career Development Award (CDA-2) proposal is designed to significantly advance the application of Behavioral Sleep Medicine practices in the treatment of Veterans seen in the VA Healthcare System, especially those recovering from traumatic brain injury (TBI). TBI has been deemed the "signature wound" of the Iraq and Afghanistan Wars, occurring in about 19.5% of Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) service members. For many Veterans, mild traumatic brain injury (mTBI) can be associated with persistent post-concussive symptoms, especially sleep disturbances. Sleep disturbances are among the most frequent complaints following mTBI, with studies suggesting that over 93% of Veterans who experienced brain injuries develop chronic sleep problems. Of the sleep disturbances diagnosed in this patient population the most common is insomnia, observed in over 50% of patients. Chronic and untreated insomnia is known to be associated with and/or increase risk for psychiatric problems, suicidal ideation, and unhealthy lifestyles (e.g., alcohol/drug abuse), lead to poorer physical health, disruption in major social and occupational responsibilities, and decreased quality of life, and may generally contribute to the persistence of post-concussive symptoms beyond the expected period of recovery. As such, treatment of sleep disturbance represents an essential component of Veteran care, one which may be particularly beneficial for Veterans with history of mTBI who commonly present to the clinic with complex multi-symptom concerns.
To address this important clinical issue, the proposed randomized clinical trial (RCT) will attempt to assess the efficacy of Cognitive-Behavioral Therapy for Insomnia (CBT-I) versus a Sleep Education control in Veterans with insomnia and a history of mTBI. CBT-I is recommended by the American Academy of Sleep Medicine for treatment of chronic insomnia and has also been adopted by the VA within an Evidence Based Practice roll-out program. Despite the acceptance of CBT-I as a first line treatment for sleep disturbance, there are no published RCTs evaluating CBT-I in mTBI patient populations. Therefore, this proposed investigation will address this gap in the literature by assessing the efficacy of CBT-I in Veterans with history of head injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-Behavioral Therapy for Insomnia | Experimental | 6-week manualized treatment designed to improve symptoms of chronic insomnia. |
|
| Sleep Education | Active Comparator | 6-week manualized treatment designed to provide information regarding traumatic brain injury and its relationship to sleep disturbance, which incorporates training in sleep hygiene to help improve nighttime sleep and daytime functioning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavioral Therapy for Insomnia | Behavioral | Intervention includes strategies designed to improve sleep such as: sleep restriction, stimulus-control techniques, sleep hygiene education, and relaxation training. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insomnia Severity | Change in insomnia severity. Scale used is Insomnia Severity Index (ISI). Minimum value= 0; maximum value = 28. Lower score equals better outcome. | Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depressive Symptomatology | Change in depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9) a self-report measure of depression. Minimum value = 0; maximum value = 27. Lower scores indicate fewer depressive symptoms. | Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain | Change in pain will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) pain assessment, as self-report measure of pain. Measures are scored on a T-score (mean=50, SD=10) Minimum score = <20 ; maximum score = >80. Lower scores indicate less pain interference in daily life. | Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
Inclusion Criteria:
OEF/OIF/OND Veteran ages 18-55.
Documented history of mild TBI (documented in the medical record and where possible from the VA TBI second-level evaluation)
At least 3 months post-TBI.
A diagnosis of insomnia classified as:
No prior exposure to and/or treatment with CBT-I within the past 2 years.
Must be stable on medication regimen for at least 1 month prior to enrollment in study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry J. Orff, PhD | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161 | United States |
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| Label | URL |
|---|---|
| The SRS fosters scientific investigations on all aspects of sleep and its disorders. | View source |
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Number of participants enrolled (73) differs from participants started due to lack of eligibility post consent/baseline or declining continued participation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive-Behavioral Therapy for Insomnia | 6-week manualized treatment designed to improve symptoms of chronic insomnia. Cognitive-Behavioral Therapy for Insomnia: Intervention includes strategies designed to improve sleep such as: sleep restriction, stimulus-control techniques, sleep hygiene education, and relaxation training. |
| FG001 | Sleep Education | 6-week manualized treatment designed to provide information regarding traumatic brain injury and its relationship to sleep disturbance, which incorporates training in sleep hygiene to help improve nighttime sleep and daytime functioning. Sleep Education: Intervention includes sleep hygiene education and education regarding the impact of TBI on sleep. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive-Behavioral Therapy for Insomnia | 6-week manualized treatment designed to improve symptoms of chronic insomnia. Cognitive-Behavioral Therapy for Insomnia: Intervention includes strategies designed to improve sleep such as: sleep restriction, stimulus-control techniques, sleep hygiene education, and relaxation training. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in Insomnia Severity | Change in insomnia severity. Scale used is Insomnia Severity Index (ISI). Minimum value= 0; maximum value = 28. Lower score equals better outcome. | Overall number of participants analyzed reflects patients assessed at week 0, and total number analyzed reflected patients who were assessed at later time points. Differences due to drop-out of patients in the study. | Posted | Mean | Standard Deviation | score on a scale | Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
|
up to 12 weeks, through study completion and follow-up
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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 | Cognitive-Behavioral Therapy for Insomnia | 6-week manualized treatment designed to improve symptoms of chronic insomnia. Cognitive-Behavioral Therapy for Insomnia: Intervention includes strategies designed to improve sleep such as: sleep restriction, stimulus-control techniques, sleep hygiene education, and relaxation training. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Henry Orff | VA San Diego Healthcare System | (858) 642-6492 | Henry.Orff@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 | Sep 26, 2023 | Oct 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Sleep Education | Behavioral | Intervention includes sleep hygiene education and education regarding the impact of TBI on sleep. |
|
| Change in PTSD Stressor Specific Checklist 5 |
Change in PTSD symptoms assessed using the PTSD Stressor Specific Checklist 5 (PCL-5) a self-report measure of PTSD. Minimum score = 0, maximum score = 80. Lower scores indicate less PTSD symptomatology. |
| Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
| Change in World Health Organization Disability Assessment Scale-2 | Change in global functioning and disability will be assessed using the World Health Organization Disability Assessment Scale-2, a self-report measure. Minimum value = 0; maximum value = 100. Lower scores indicates less disability. | Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
| Change in Pittsburgh Sleep Quality Index | Change in sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI). Minimum value = 0; maximum value= 21. Lower score indicates less general sleep disturbance. | Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
| Change in Neuropsychological Functioning: Attention/Processing Speed | Change in cognitive functioning will be evaluated through standardized assessments of attention and processing speed. The tasks that will be administered include: the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Digit Symbol and Symbol Search to measure attention and processing speed. WAIS-IV raw minimum value score=45; maximum score=155. Scaled score used: minimum score = 1; maximum score = 19. Higher score equals a better outcome. | Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
| Change In Neuropsychological Functioning: Verbal Learning and Memory | Change in cognitive functioning will be evaluated through standardized assessments of verbal learning and memory. The Hopkins Verbal Learning Test-Revised (HVLT-R) was used to measure learning and memory, and was measured by "Total Recall" score and "Delayed Recall" score. HVLT Total Recall raw scores minimum value=0; maximum value=36. Measures scored on a T-Score; minimum t-score score:0, maximum t-score >80. Higher t-scores indicate better outcome. HVLT delayed recall minimum raw score value=0; maximum value=12. Measures scored on a T-Score; maximum t-score value: 60, minimum =0. Higher t-scores indicate better outcome. Population mean and standard deviation calculated based on age. Mean age of the population was 36 years = total recall population t score mean: 28.04, SD: 4.43. Delayed recall population t score mean: 9.92, SD: 2.04. | Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
| Change In Neuropsychological Functioning: Executive Functioning | Change in cognitive functioning will be evaluated through standardized assessments of executive functioning. The Delis-Kaplan Executive Function Scale (D-KEFS) Trials and Color-Word Tasks was used to measure executive functioning, as measured by Color-Word Inhibition, Color-Word Switching Inhibition, and Trails. Scored using a scaled-score (minimum=1, maximum=19 for all measures). Higher scores indicate better outcome. | Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
| Change in Sleep Efficiency as Measured by Polysomnography | Change in sleep efficiency will be assessed through overnight polysomnographic sleep studies. | Pre-Treatment (0-weeks),Post-Treatment (8-weeks), Follow-Up (12-weeks) |
| Sleep Education |
6-week manualized treatment designed to provide information regarding traumatic brain injury and its relationship to sleep disturbance, which incorporates training in sleep hygiene to help improve nighttime sleep and daytime functioning. Sleep Education: Intervention includes sleep hygiene education and education regarding the impact of TBI on sleep. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Sleep Education | 6-week manualized treatment designed to provide information regarding traumatic brain injury and its relationship to sleep disturbance, which incorporates training in sleep hygiene to help improve nighttime sleep and daytime functioning. Sleep Education: Intervention includes sleep hygiene education and education regarding the impact of TBI on sleep. |
|
|
| Secondary | Change in Depressive Symptomatology | Change in depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9) a self-report measure of depression. Minimum value = 0; maximum value = 27. Lower scores indicate fewer depressive symptoms. | Overall number of participants analyzed reflects patients assessed at week 0, and total number analyzed reflected patients who were assessed at later time points. Differences due to drop-out of patients in the study. | Posted | Mean | Standard Deviation | score on a scale | Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
|
|
|
| Secondary | Change in PTSD Stressor Specific Checklist 5 | Change in PTSD symptoms assessed using the PTSD Stressor Specific Checklist 5 (PCL-5) a self-report measure of PTSD. Minimum score = 0, maximum score = 80. Lower scores indicate less PTSD symptomatology. | Difference in overall number of participants and number analyzed differs due to lack of completion of treatment. Overall number refers to those who were assessed at week-0 treatment. | Posted | Mean | Standard Deviation | score on a scale | Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
|
|
|
| Secondary | Change in World Health Organization Disability Assessment Scale-2 | Change in global functioning and disability will be assessed using the World Health Organization Disability Assessment Scale-2, a self-report measure. Minimum value = 0; maximum value = 100. Lower scores indicates less disability. | Overall number of participants analyzed reflects patients assessed at week 0, and total number analyzed reflected patients who were assessed at later time points. Differences due to drop-out of patients in the study. | Posted | Mean | Standard Deviation | score on a scale | Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
|
|
|
| Secondary | Change in Pittsburgh Sleep Quality Index | Change in sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI). Minimum value = 0; maximum value= 21. Lower score indicates less general sleep disturbance. | Overall number of participants analyzed reflects patients assessed at week 0, and total number analyzed reflected patients who were assessed at later time points. Differences due to drop-out of patients in the study. | Posted | Mean | Standard Deviation | score on a scale | Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
|
|
|
| Other Pre-specified | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain | Change in pain will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) pain assessment, as self-report measure of pain. Measures are scored on a T-score (mean=50, SD=10) Minimum score = <20 ; maximum score = >80. Lower scores indicate less pain interference in daily life. | Overall number of participants analyzed reflects patients assessed at week 0, and total number analyzed reflected patients who were assessed at later time points. Differences due to drop-out of patients in the study. | Posted | Mean | Standard Deviation | score on a scale | Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
|
|
|
| Other Pre-specified | Change in Neuropsychological Functioning: Attention/Processing Speed | Change in cognitive functioning will be evaluated through standardized assessments of attention and processing speed. The tasks that will be administered include: the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Digit Symbol and Symbol Search to measure attention and processing speed. WAIS-IV raw minimum value score=45; maximum score=155. Scaled score used: minimum score = 1; maximum score = 19. Higher score equals a better outcome. | Overall number of participants analyzed reflects patients assessed at week 0, and total number analyzed reflected patients who were assessed at later time points. Differences due to drop-out of patients in the study. | Posted | Mean | Standard Deviation | score on a scale | Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
|
|
|
| Other Pre-specified | Change In Neuropsychological Functioning: Verbal Learning and Memory | Change in cognitive functioning will be evaluated through standardized assessments of verbal learning and memory. The Hopkins Verbal Learning Test-Revised (HVLT-R) was used to measure learning and memory, and was measured by "Total Recall" score and "Delayed Recall" score. HVLT Total Recall raw scores minimum value=0; maximum value=36. Measures scored on a T-Score; minimum t-score score:0, maximum t-score >80. Higher t-scores indicate better outcome. HVLT delayed recall minimum raw score value=0; maximum value=12. Measures scored on a T-Score; maximum t-score value: 60, minimum =0. Higher t-scores indicate better outcome. Population mean and standard deviation calculated based on age. Mean age of the population was 36 years = total recall population t score mean: 28.04, SD: 4.43. Delayed recall population t score mean: 9.92, SD: 2.04. | Overall number of participants analyzed reflects patients assessed at week 0, and total number analyzed reflected patients who were assessed at later time points. Differences due to drop-out of patients in the study. | Posted | Mean | Standard Deviation | score on a scale | Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
|
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| Other Pre-specified | Change In Neuropsychological Functioning: Executive Functioning | Change in cognitive functioning will be evaluated through standardized assessments of executive functioning. The Delis-Kaplan Executive Function Scale (D-KEFS) Trials and Color-Word Tasks was used to measure executive functioning, as measured by Color-Word Inhibition, Color-Word Switching Inhibition, and Trails. Scored using a scaled-score (minimum=1, maximum=19 for all measures). Higher scores indicate better outcome. | Overall number of participants analyzed reflects patients assessed at week 0, and total number analyzed reflected patients who were assessed at later time points. Differences due to drop-out of patients in the study. | Posted | Mean | Standard Deviation | score on a scale | Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks) |
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| Other Pre-specified | Change in Sleep Efficiency as Measured by Polysomnography | Change in sleep efficiency will be assessed through overnight polysomnographic sleep studies. | Data not collected due to pandemic. | Posted | Pre-Treatment (0-weeks),Post-Treatment (8-weeks), Follow-Up (12-weeks) |
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Sleep Education | 6-week manualized treatment designed to provide information regarding traumatic brain injury and its relationship to sleep disturbance, which incorporates training in sleep hygiene to help improve nighttime sleep and daytime functioning. Sleep Education: Intervention includes sleep hygiene education and education regarding the impact of TBI on sleep. | 0 | 28 | 0 | 28 | 0 | 28 |
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| D001523 |
| Mental Disorders |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |
| PHQ-9 Pre to Follow-Up |
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| PCL-5 Pre to Follow-Up |
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| WHODAS Pre to Follow-Up |
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| PSQI Pre to Follow-Up |
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| PROMIS Pre to Follow-Up |
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| Symbol Search WAIS Pre to Follow-Up |
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| Coding WAIS Pre to Post |
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| Coding WAIS Pre to Follow-Up |
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| HVLT Total Pre to Follow-Up T-Score |
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| HVLT Delayed Pre to Post T-Score |
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| HVLT Delayed Pre to Follow-Up T-Score |
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| DKEFS Color-Word Inhibition Pre to Follow-Up |
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| DKEFS Color Word Inhibition Switching Pre to Post |
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| DKEFS Color Word Inhibition Switching Pre to Follow-Up |
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| DKEFS Trails Pre to Post |
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| DKEFS Trails Pre to Follow-Up |
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