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Sleep therapy shows promise for fibromyalgia pain relief

NCT ID NCT03744156

Symptom relief Sponsor: University of Missouri-Columbia Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether cognitive behavioral therapy for insomnia (CBT-I) can improve sleep and reduce pain in women with fibromyalgia. 131 women with both conditions received either CBT-I or sleep hygiene education. Researchers measured sleep quality, pain sensitivity, and brain changes to see if treating insomnia helps ease chronic pain.

What this could mean

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

Active substance
Cognitive Behavioral Therapy for Insomnia (CBT-I)
What this could lead to
If it works, this could point toward a non-drug way to improve sleep and reduce pain in women with fibromyalgia.
What could go wrong
This is a completed study with 131 participants, so results are limited in size. The treatment may not work for everyone, and benefits might not last long-term.

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

131 people

The number who actually took part.

Started

Feb 2019

Finished

May 2025

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

Female participants only

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: * female * 18+ years of age * willing to be randomized * can read and understand English * diagnosed with Fibromyalgia and insomnia * no prescript or over the counter pain or sleep medicaments for 1+ month Exclusion Criteria: * unable to provide informed consent * cognitive impairment * sleep disorder other than insomnia (i.e., sleep apnea, periodic limb movement disorder * bipolar or seizure disorder * other major psychopathology (other than depression or anxiety) * psychotropic or other medications that alter pain or sleep * participation in non-pharmacological treatment (including CBT) for pain, sleep, or mood outside current trial * internal metal objects or electrical devices * pregnancy

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Conditions

The condition(s) this trial relates to.

Chronic Pain fibromyalgia insomnia

As listed by the trial registrant

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

Chronic widespread pain Fibromyalgia Insomnia

Contacts and locations

Locations

  • University of Missouri- Department of Psychiatry

    Columbia, Missouri, 65210, United States

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