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Completed

NCT Number: NCT05520710

Symptom-Targeted Rehabilitation for Concussion

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. 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.

  2. Adherence to Intervention

    Time frame: 12 months

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

Secondary outcomes

  1. Acceptability of the Intervention

    Time frame: Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.

    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).

  2. Acceptability of the Appropriateness

    Time frame: Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.

    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).

  3. Acceptability of the Feasibility

    Time frame: Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.

    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).

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Atlas Institute for Veterans and Families

Registry information

Official study title

Symptom-Targeted Rehabilitation for Concussion in Canadian Armed Forces Veterans

Acronym: STAR-C2

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 30, 2022
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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