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New study tests mindfulness therapy for sleep in sickle cell disease

NCT ID NCT05457790

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether acceptance and commitment therapy (ACT) can improve sleep for adults with sickle cell disease. Participants will have weekly video chats with a coach for 8 weeks and wear a wrist device to track sleep. The goal is to see if this approach is practical and helpful for managing sleep problems.

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

3 people

The number who actually took part.

Started

May 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

18 to 55 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: * Ability of participant to understand and the willingness to sign a written informed consent document * Ability to read and speak English * Age \>=18 - \<= 55 years * Self-reported active diagnosis of Sickle Cell Disease * Must score a T-score of 57.5 or higher from the PROMIS Sleep Disturbance Scale * Self-reported sleep disturbance of at least 3 months * Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone or tablet with internet access and either a USB port or Bluetooth capability) * Must be willing to register online and install the software to use the actigraph and willing to complete the sleep diaries * Must be able and willing to attend remote ACT coaching calls during the study team s working hours EXCLUSION CRITERIA: * Uncontrolled psychiatric illness, cognitive impairments, or other circumstance as judged by the Principal Investigator (PI) or Lead Associate Investigator (LAI), both licensed psychologists, that would limit compliance with study requirements * Evidence of disease progression at the time of referral to this study to the extent that it would impede participation or completion of evaluations as determined by the medical advisory investigator in conjunction with the study PI/LAI * Individuals who are planning to start a new treatment or who are planning to change medications (e.g., pharmacological, dietary supplements, or psychological) for sleep disturbance or that have been known to significantly affect sleep in the next 6 months (Current sleep medication is not an exclusion criteria) * Individuals currently enrolled in a treatment protocol that would impact sleep * Previous treatment that cured sickle cell disease. * Individuals scheduled to receive gene therapy or stem cell therapy, or begin the conditioning regimen for these procedures, in the next 6 months

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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

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  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

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Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

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