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Clinical Trials/NCT05520710
NCT05520710
Completed
Not Applicable

Symptom-Targeted Rehabilitation for Concussion in Canadian Armed Forces Veterans

McMaster University1 site in 1 country55 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Traumatic Brain Injury
Sponsor
McMaster University
Enrollment
55
Locations
1
Primary Endpoint
Adherence to Intervention
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
August 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Adherence to Intervention

Time Frame: 12 months

Three quarters of participants should complete 80% of the prescribed intervention

Recruitment Rate

Time Frame: 12 months

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.

Secondary Outcomes

  • Acceptability of the Intervention(Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.)
  • Acceptability of the Appropriateness(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(Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.)

Study Sites (1)

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