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Can a smartphone app and a coach help young sickle cell patients hurt less?

NCT ID NCT06374238

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a digital cognitive behavioral therapy (CBT) program, with or without a peer health coach, can reduce pain and opioid use in 470 teens and young adults (ages 16–30) with sickle cell disease and chronic pain. Participants use an app to track pain and mood, and some get weekly calls from a trained peer coach. The goal is to see if these tools improve pain intensity and daily functioning compared to usual care.

What this could mean

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

Active substance
digital cognitive behavioral therapy (CBT) with or without a peer health coach
What this could lead to
If it works, this could offer a practical, non-drug way to manage chronic pain and reduce opioid use for young people with sickle cell disease.
What could go wrong
This is a behavioral intervention study, not a drug trial, so benefits may be modest. Results depend on participants sticking with the app and coaching, which can be challenging.

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 470 people

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

Started

Mar 2025

Expected to finish

May 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

16 to 30 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 16 to 30 years of age at time of enrollment 2. Sickle Cell Disease diagnosis of any genotype based on referral or documentation 3. Reports chronic pain (≥4 days/week for past 3 months or more) OR A) Being prescribed pain medication to be taken (≥4 days/week for past 3 months or more) OR B) Taking pain medication (≥4 days/week for past 3 months or more) OR C) Receiving non-pharmaceutical pain treatment (≥4 days/week for past 3 months or more) 4. Access to an iOS or Android mobile device with internet access Exclusion Criteria: 1. Unable to speak or read English 2. Prior hematopoietic stem cell transplant for sickle cell disease

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    14 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Ann and Robert H. Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Children's Healthcare of Atlanta

    RECRUITING

    Atlanta, Georgia, 30345, United States

  • Connecticut Children's Medical Center

    RECRUITING

    Hartford, Connecticut, 06106, United States

  • East Carolina University Health Medical Center

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Rutgers New Jersey Medical School

    RECRUITING

    Newark, New Jersey, 07103, United States

  • The Regents of the University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109-1079, United States

  • UCLA Mattel Children's Hospital Ronald Reagan Hospital

    RECRUITING

    Los Angeles, California, 90095, United States

  • UPMC Children's Hospital of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • UPMC University of Pittsburgh Classical Hematology Adult Clinic

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

    Contact Email: •••••@•••••

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642, United States

  • University of South Alabama Medical Center

    RECRUITING

    Mobile, Alabama, 36617, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23284, United States

  • Wake Forest Baptist Hospital

    RECRUITING

    Durham, North Carolina, 27106, United States

  • Weil Cornell Medical College

    RECRUITING

    New York, New York, 10065, United States

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