MedTrace Logo

Sleep and Pain Interventions in Women With Fibromyalgia

NCT03744156 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2025-10-01

No results posted yet for this study

Summary

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.

Conditions

  • Fibromyalgia
  • Insomnia
  • Chronic Widespread Pain

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.

Sponsors & Collaborators

  • University of Florida

    collaborator OTHER

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Christina McCrae, PhD · University of Missouri-Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03744156 on ClinicalTrials.gov