Clinical Trial Finder

Sleep and Pain Interventions in Women With Fibromyalgia

Study Purpose

Insomnia affects 67-88% of chronic pain patients. SPIN II is a randomized controlled clinical trial that will compare the effects of two cognitive behavioral sleep treatments in women with fibromyalgia and insomnia. This trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender Female
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03744156
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Missouri-Columbia
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Christina McCrae, PhD
Principal Investigator Affiliation University of Missouri-Columbia
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Fibromyalgia, Insomnia, Chronic Widespread Pain
Additional Details

This mechanistic trial will assess sleep, pain, arousal, and neural imagining outcomes at baseline, post-8 week behavioral treatment (CBT-I or SHE), as well as at 6 and 12 month followups. This information will provide novel information about the neural structures and functional networks associated with chronic pain, and their manipulation through a cognitive behavioral intervention to improve insomnia. Demonstration that a relatively brief intervention can reverse or resolve pain related maladaptive neural plasticity, and improve or resolve clinical pain symptoms would have immediate and far-reaching implications for millions of chronic pain sufferers as well as for the US healthcare system and economy.

Arms & Interventions

Arms

Experimental: Cognitive Behavioral Treatment-Insomnia

Cognitive Behavioral Treatment-Insomnia. 8 Session treatment focusing on behavior and cognitions related to sleep and pain.

Experimental: Sleep Hygiene Education

Sleep Hygiene Education. 8 Session treatment focusing on sleep hygiene education.

Interventions

Behavioral: - Cognitive Behavioral Treatment-Insomnia

8 session Cognitive Behavioral Therapy for Insomnia. Individualized sessions with a therapist.

Behavioral: - Sleep Hygiene Education

8 Session Sleep Hygiene Education. Individualized sessions with a therapist.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Columbia, Missouri

Status

Recruiting

Address

University of Missouri- Department of Psychiatry

Columbia, Missouri, 65210

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