RECRUITING

Sleep and Pain Interventions in Women With Fibromyalgia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Impact of CBT for Insomnia on Pain Symptoms and Central Sensitization in Fibromyalgia

Quick Facts

Study Start:2019-02-07
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03744156

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * female
  2. * 18+ years of age
  3. * willing to be randomized
  4. * can read and understand English
  5. * diagnosed with Fibromyalgia and insomnia
  6. * no prescript or over the counter pain or sleep medicaments for 1+ month
  1. * unable to provide informed consent
  2. * cognitive impairment
  3. * sleep disorder other than insomnia (i.e., sleep apnea, periodic limb movement disorder
  4. * bipolar or seizure disorder
  5. * other major psychopathology (other than depression or anxiety)
  6. * psychotropic or other medications that alter pain or sleep
  7. * participation in non-pharmacological treatment (including CBT) for pain, sleep, or mood outside current trial
  8. * internal metal objects or electrical devices
  9. * pregnancy

Contacts and Locations

Study Contact

Austin D Ohley, BS
CONTACT
(573) 882-5113
ajobzr@health.missouri.edu

Principal Investigator

Christina McCrae, PhD
PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia

Study Locations (Sites)

University of Missouri- Department of Psychiatry
Columbia, Missouri, 65210
United States

Collaborators and Investigators

Sponsor: University of Missouri-Columbia

  • Christina McCrae, PhD, PRINCIPAL_INVESTIGATOR, University of Missouri-Columbia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-02-07
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2019-02-07
Study Completion Date2025-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Fibromyalgia
  • Insomnia
  • Chronic Widespread Pain