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Sleep Interventions for Fibromyalgia (SPIN-II Trial)

N/A
Recruiting
Led By Christina McCrae, PhD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to follow-up (approximately 60 weeks)
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the effects of two cognitive behavioral sleep treatments in women with fibromyalgia and insomnia. The results will provide information about the roles of sleep, arousal, and brain structure and function in chronic pain development and maintenance in women with fibromyalgia.

Who is the study for?
This trial is for women over 18 with fibromyalgia and insomnia who can read English. They shouldn't be taking pain or sleep medications for at least a month, have no major psychological issues besides depression or anxiety, no cognitive impairments, other sleep disorders, or be pregnant.
What is being tested?
The SPIN II study compares two types of cognitive behavioral treatments focused on improving sleep in women with fibromyalgia. It aims to understand how better sleep might affect chronic pain by looking at brain function and arousal levels.
What are the potential side effects?
Since the interventions are non-pharmacological focusing on behavior therapy and education, significant side effects are not expected. However, participants may experience changes in mood or stress due to alterations in their sleeping patterns.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to follow-up (approximately 60 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to follow-up (approximately 60 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Bedtime, Wake time, Sleep Onset Latency, and Wake After Sleep Onset measured by Actigraphy
Change in Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
Change in Insomnia Severity Index (ISI)
+7 more
Secondary study objectives
Activities of Daily Living (ADL) - Katz ADL Scale
Biomarkers - Neurodegeneration and Inflammation
Anxiety
+14 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sleep Hygiene EducationExperimental Treatment1 Intervention
Sleep Hygiene Education. 8 Session treatment focusing on sleep hygiene education.
Group II: Cognitive Behavioral Treatment-InsomniaExperimental Treatment1 Intervention
Cognitive Behavioral Treatment-Insomnia. 8 Session treatment focusing on behavior and cognitions related to sleep and pain.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Hygiene Education
2022
Completed Phase 4
~1550

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
379 Previous Clinical Trials
628,364 Total Patients Enrolled
University of FloridaOTHER
1,401 Previous Clinical Trials
766,879 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
600 Previous Clinical Trials
10,377,449 Total Patients Enrolled
~7 spots leftby Mar 2025
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