search
Back to results

Symptom-Targeted Rehabilitation for Concussion (STAR-C2)

Primary Purpose

Mild Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Rehabilitation
Education
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Traumatic Brain Injury focused on measuring Cognitive Rehabilitation, Cognitive Functioning

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Is a community-dwelling Canadian Armed Forces veteran.
  • Is age 18 years or older.
  • Self-identifies as a fluent English speaker.
  • Has no previous history of neurological disorder affecting cognition, by self-report.
  • Is able to participate in rehabilitation for 4 weeks: 3 weeks of treatment + baseline + outcome assessment, with potential rescheduling for missed sessions.
  • Is not actively participating in cognitive rehabilitation directed by a registered health professional (e.g., speech-language pathologist or occupational therapist).
  • Has access to an electronic device with Zoom video platform capacity and internet access.

Exclusion Criteria:

  • A score of less than 20 on the Montreal Cognitive Assessment (MoCA), which indicates a risk for dementia.
  • Cannot identify at least 3 problems on the Common Cognitive Complaints after Concussion Questionnaire (C4), as there would be insufficient areas for intervention.

Sites / Locations

  • McMaster UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Therapy Group

Educational Group

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

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.
Adherence to Intervention
Three quarters of participants should complete 80% of the prescribed intervention

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
August 19, 2022
Last Updated
January 12, 2023
Sponsor
McMaster University
Collaborators
Atlas Institute for Veterans and Families
search

1. Study Identification

Unique Protocol Identification Number
NCT05520710
Brief Title
Symptom-Targeted Rehabilitation for Concussion
Acronym
STAR-C2
Official Title
Symptom-Targeted Rehabilitation for Concussion in Canadian Armed Forces Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Atlas Institute for Veterans and Families

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury
Keywords
Cognitive Rehabilitation, Cognitive Functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
Assessor will be blinded to randomization
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapy Group
Arm Type
Experimental
Arm Description
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)
Arm Title
Educational Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Rehabilitation
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Educational materials, designed to help people with traumatic brain injury manage their everyday cognitive challenges will be provided through Zoom video conferencing software.
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
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.
Time Frame
12 months
Title
Adherence to Intervention
Description
Three quarters of participants should complete 80% of the prescribed intervention
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Acceptability of the Intervention
Description
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).
Time Frame
Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.
Title
Acceptability of the Appropriateness
Description
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).
Time Frame
Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.
Title
Acceptability of the Feasibility
Description
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).
Time Frame
Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is a community-dwelling Canadian Armed Forces veteran. Is age 18 years or older. Self-identifies as a fluent English speaker. Has no previous history of neurological disorder affecting cognition, by self-report. Is able to participate in rehabilitation for 4 weeks: 3 weeks of treatment + baseline + outcome assessment, with potential rescheduling for missed sessions. Is not actively participating in cognitive rehabilitation directed by a registered health professional (e.g., speech-language pathologist or occupational therapist). Has access to an electronic device with Zoom video platform capacity and internet access. Exclusion Criteria: A score of less than 20 on the Montreal Cognitive Assessment (MoCA), which indicates a risk for dementia. Cannot identify at least 3 problems on the Common Cognitive Complaints after Concussion Questionnaire (C4), as there would be insufficient areas for intervention.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Hagens
Phone
905-525-9140
Ext
27857
Email
hagens@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyn Turkstra, PhD
Organizational Affiliation
McMaster University School of Rehabilitation Science
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jackie Bosch, PhD
Organizational Affiliation
McMaster University School of Rehabilitation Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Hagens
Phone
9055259140
Ext
27857
Email
talklab@mcmaster.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25410348
Citation
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.
Results Reference
background
PubMed Identifier
24625213
Citation
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.
Results Reference
background
PubMed Identifier
24568300
Citation
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.
Results Reference
background
PubMed Identifier
30640181
Citation
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.
Results Reference
background
PubMed Identifier
20108447
Citation
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.
Results Reference
background
PubMed Identifier
31479073
Citation
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.
Results Reference
background
PubMed Identifier
30926291
Citation
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.
Results Reference
background
PubMed Identifier
25871303
Citation
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.
Results Reference
background
PubMed Identifier
27603763
Citation
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.
Results Reference
background
PubMed Identifier
15817019
Citation
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. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
Results Reference
background
PubMed Identifier
1991015
Citation
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.
Results Reference
background
PubMed Identifier
26606250
Citation
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.
Results Reference
background
PubMed Identifier
28851459
Citation
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.
Results Reference
background
Links:
URL
https://www.thecopm.ca/
Description
The Canadian Occupational Performance Measure

Learn more about this trial

Symptom-Targeted Rehabilitation for Concussion

We'll reach out to this number within 24 hrs