A new approach to taming Post-TBI fatigue: can group therapy delivered online make a difference?

NCT ID NCT07798245

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This trial tests whether a remote group program called FACETS-TBI can help adults with traumatic brain injury (TBI) manage persistent fatigue. Participants are randomly assigned to either the FACETS-TBI program or an attention control group that discusses healthy lifestyle topics. The study measures feasibility, satisfaction, and changes in fatigue and daily participation. It also includes interviews to gather participant feedback.

What this could mean

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

Active substance
FACETS-TBI, a remotely delivered, group-based fatigue self-management program using cognitive behavioral and energy effectiveness techniques
What this could lead to
If it works, this program could offer a practical, accessible way for adults with TBI to reduce fatigue and improve daily participation.
What could go wrong
This is an early feasibility study, so it may not show clear benefits. The program requires regular attendance and may not suit everyone.

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 66 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

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 years and older

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: * 6 months post-mild to severe TBI based on the Ohio State University TBI Identification Method (OSU TBI-ID)\] * Fatigue Severity Scale score ≥4 * Community dwelling * Able to operate a computer (independently or assisted) * English fluency * 18 years old * Capacity to self-consent * No severe major depression; PHQ8 score ≤20 Exclusion Criteria: * Self-reported history of neurodegenerative condition or schizophrenia * No severe depression; PHQ8 score ≤ 10

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

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

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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