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| Name | Class |
|---|---|
| Atlas Institute for Veterans and Families | UNKNOWN |
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The investigators are comparing two methods for helping improve everyday cognitive functioning in Canadian Armed Forces (CAF) veterans who have sustained a mild traumatic brain injury (mTBI). The two methods are 1) providing educational materials (Education Group) and 2) individual cognitive rehabilitation delivered by a trained Occupational Therapist or Speech-Language Pathologist (Therapy Group). The study is a pilot randomized controlled clinical trial (RCT), and will serve as pilot data for a future RCT.
The investigators are comparing two different methods for helping Canadian Armed Forces veterans with mild traumatic brain injury (mTBI) manage everyday cognitive difficulties. Cognitive rehabilitation is a type of therapy that helps people with brain injury who have challenges in everyday thinking. The investigators have developed a streamlined version of this type of cognitive rehabilitation therapy that can be done in person or virtually and takes place over a 3-week period. The investigators will provide education materials only to one group and individual cognitive rehabilitation delivered by a trained Speech Language Pathologist or Occupational Therapist to the other group. The investigators want to find out whether the individual therapy is better than providing the usual educational material. The therapy sessions are audio-recorded. At McMaster, the investigators job is to listen to the recordings and making sure the therapists are following the study manual. That includes making notes of what the therapists say or do. What the investigators learn in this study may help veterans with mTBI and cognitive issues affect their abilities to do everyday activities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy Group | Experimental | The Therapy Group will receive 6-10 individual sessions of 30-60 minutes each, delivered by a trained Occupational Therapist or Speech-Language Pathologist. The therapy will be delivered over a 4-week timeframe, with the total number of sessions per participant depending on the number of sessions needed to achieve their treatment targets. Each participant in the Therapy Group will identify three cognitive targets for treatment. Progress in reaching those targets will be documented using Goal Attainment Scaling (GAS) |
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| Educational Group | Active Comparator | The education group will receive information about self-management of cognitive symptoms at the time of randomization, a common intervention for adults with mild Traumatic Brain Injury. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Rehabilitation | Behavioral | A strategy-focused intervention aimed at improving everyday cognitive function, structured to maximize treatment dose over a short time period. The shorter time period of the treatment therapy is relative to the one and only current randomized controlled trial of cognitive rehabilitation for military mTBI, the Study of Cognitive Rehabilitation Effectiveness (SCORE). |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | The primary outcome is the rate of recruitment, average 5 per month. The primary outcome is the rate of recruitment and retention rate reported as total number of participants recruited and retained. | 12 months |
| Adherence to Intervention | Three quarters of participants should complete 80% of the prescribed intervention | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the Intervention | The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Acceptability of Intervention Measure (AIM). | Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyn Turkstra, PhD | McMaster University School of Rehabilitation Science | Principal Investigator |
| Jackie Bosch, PhD | McMaster University School of Rehabilitation Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25410348 | Background | Garber BG, Rusu C, Zamorski MA. Deployment-related mild traumatic brain injury, mental health problems, and post-concussive symptoms in Canadian Armed Forces personnel. BMC Psychiatry. 2014 Nov 20;14:325. doi: 10.1186/s12888-014-0325-5. | |
| 24625213 | Background | Soble JR, Silva MA, Vanderploeg RD, Curtiss G, Belanger HG, Donnell AJ, Scott SG. Normative Data for the Neurobehavioral Symptom Inventory (NSI) and post-concussion symptom profiles among TBI, PTSD, and nonclinical samples. Clin Neuropsychol. 2014;28(4):614-32. doi: 10.1080/13854046.2014.894576. Epub 2014 Mar 14. |
| Label | URL |
|---|---|
| The Canadian Occupational Performance Measure | View source |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Participants will be randomized to either the Therapy (n=30) or Education Group (n=30). At the conclusion of therapy (for the Therapy Group) or after three weeks (for the Education Group), participants will be re-administered the outcome measures. The outcome measures using the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) will then be compared during data analysis between the two groups.
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Assessor will be blinded to randomization
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| Education | Other | Educational materials, designed to help people with traumatic brain injury manage their everyday cognitive challenges will be provided through Zoom video conferencing software. |
|
| Acceptability of the Appropriateness | The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Intervention Appropriateness Measure (IAM). | Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment. |
| Acceptability of the Feasibility | The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Feasibility of Intervention Measure (FIM). | Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment. |
| 24568300 | Background | Tanev KS, Pentel KZ, Kredlow MA, Charney ME. PTSD and TBI co-morbidity: scope, clinical presentation and treatment options. Brain Inj. 2014;28(3):261-70. doi: 10.3109/02699052.2013.873821. |
| 30640181 | Background | Hoffman AN, Taylor AN. Stress reactivity after traumatic brain injury: implications for comorbid post-traumatic stress disorder. Behav Pharmacol. 2019 Apr;30(2 and 3-Spec Issue):115-121. doi: 10.1097/FBP.0000000000000461. |
| 20108447 | Background | Management of Concussion/mTBI Working Group. VA/DoD Clinical Practice Guideline for Management of Concussion/Mild Traumatic Brain Injury. J Rehabil Res Dev. 2009;46(6):CP1-68. No abstract available. |
| 31479073 | Background | Loignon A, Ouellet MC, Belleville G. A Systematic Review and Meta-analysis on PTSD Following TBI Among Military/Veteran and Civilian Populations. J Head Trauma Rehabil. 2020 Jan/Feb;35(1):E21-E35. doi: 10.1097/HTR.0000000000000514. |
| 30926291 | Background | Cicerone KD, Goldin Y, Ganci K, Rosenbaum A, Wethe JV, Langenbahn DM, Malec JF, Bergquist TF, Kingsley K, Nagele D, Trexler L, Fraas M, Bogdanova Y, Harley JP. Evidence-Based Cognitive Rehabilitation: Systematic Review of the Literature From 2009 Through 2014. Arch Phys Med Rehabil. 2019 Aug;100(8):1515-1533. doi: 10.1016/j.apmr.2019.02.011. Epub 2019 Mar 26. |
| 25871303 | Background | Marshall S, Bayley M, McCullagh S, Velikonja D, Berrigan L, Ouchterlony D, Weegar K; mTBI Expert Consensus Group. Updated clinical practice guidelines for concussion/mild traumatic brain injury and persistent symptoms. Brain Inj. 2015;29(6):688-700. doi: 10.3109/02699052.2015.1004755. Epub 2015 Apr 14. |
| 27603763 | Background | Cooper DB, Bowles AO, Kennedy JE, Curtiss G, French LM, Tate DF, Vanderploeg RD. Cognitive Rehabilitation for Military Service Members With Mild Traumatic Brain Injury: A Randomized Clinical Trial. J Head Trauma Rehabil. 2017 May/Jun;32(3):E1-E15. doi: 10.1097/HTR.0000000000000254. |
| 15817019 | Background | Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. |
| 1991015 | Background | Malec JF, Smigielski JS, DePompolo RW. Goal attainment scaling and outcome measurement in postacute brain injury rehabilitation. Arch Phys Med Rehabil. 1991 Feb;72(2):138-43. |
| 26606250 | Background | Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25. |
| 28851459 | Background | Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |