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New therapy aims to break the fear cycle after concussion

NCT ID NCT05365776

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a type of talk therapy called graded exposure therapy for people who have had a concussion and are still having symptoms. The therapy, delivered by a psychologist over 12 video sessions, helps people gradually face activities they have been avoiding due to fear of making symptoms worse. The trial includes 220 adults aged 18-70 who had a concussion 1 to 24 months ago.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Graded exposure therapy (behavioural therapy via videoconference)
What this could lead to
If it works, this could provide an effective, accessible treatment for people struggling with persistent symptoms after a concussion.
What could go wrong
This is a single trial with 220 participants, and the therapy requires active participation and homework. Results may not apply to everyone with concussion.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 69 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. aged 18-70 years; 2. sustained a concussion according to the ACRM mTBI Task Force definition between 1 and 24 months ago 3. fluent in English, because validated translations are not available for most questionnaires and recruiting multilingual therapists is not feasible; 4. access to a computer, tablet, or smartphone with internet capability; 5. 3 or more moderate-severe symptoms on the Rivermead Postconcussion Symptom Questionnaire. Exclusion Criteria: 1. medical contraindication to aerobic exercise (cardiac disease, chest pain with exertion, acute bone/joint/soft tissue injury aggravated by exercise) 2. change in cardiac medication within the last month, such as beta blockers, calcium channel blockers, or ivabradine 3. involved in personal injury litigation for index mTBI 4. currently pregnant or plan to become pregnant within the next three months 5. severe/unstable medical or psychiatric condition that could worsen over the next year")

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Conditions

The condition(s) this trial relates to.

Brain Concussion traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Calgary Brain Injury Program

    Calgary, Alberta, T2N 2T9, Canada

  • Fraser Health Acquired Brain Injury and Concussion Services

    Langley, British Columbia, V1M 4A6, Canada

  • G.F. Strong Adult Concussion Services

    Vancouver, British Columbia, V5Z 2G9, Canada

  • Head Injury Clinic at St. Michael's

    Toronto, Ontario, M5B 1W8, Canada

  • Hull-Ellis Concussion and Research Clinic

    Toronto, Ontario, M5G 2A2, Canada

  • Sunnybrooke Traumatic Brain Injury Clinic

    Toronto, Ontario, M4N 3M5, Canada

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8, Canada

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