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Mindfulness and exposure therapy may ease fear after ACL surgery

NCT ID NCT05949177

Symptom relief Sponsor: University of North Carolina, Chapel Hill Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether combining graded exposure therapy with mindfulness meditation (via the Headspace app) can reduce injury-related fear and improve reaction time in people who had ACL reconstruction. Fifty participants aged 14-35, who are 6 months to 10 years post-surgery and have elevated fear, will be randomly assigned to the program or a waitlist. The goal is to help them feel less anxious about re-injury and move more confidently.

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 and mindfulness meditation via the Headspace app
What this could lead to
If it works, this could offer a simple, non-drug way to help people overcome fear of re-injury after ACL surgery and return to sports more confidently.
What could go wrong
This is a small, early-stage trial with only 50 people, and it compares the program to a waitlist (no active control). The results may not apply to everyone, and the benefits might be modest.

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 50 people

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

Started

Oct 2024

Expected to finish

Jul 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

14 to 35 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: * Ages 14-35 years * Have self-reported levels of fear on the Tampa Scale of Kinesiophobia-11 and the Photographic Series of Sports Activities for ACLR * Injured their knee playing or training for sports (recreational or organized) * Have a history of unilateral ACLR * 6 months to 10-years post-ACLR Exclusion Criteria: * History of secondary ACL injury * Do not exhibit elevated injury-related fear * Concomitant surgeries at the time of ACL reconstruction

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Conditions

The condition(s) this trial relates to.

Anterior Cruciate Ligament Injuries

As listed by the trial registrant

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

Anterior cruciate ligament injuries

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Woollen Gymnasium, 300 South Road

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

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