NCT03744156

Sleep and Pain Interventions in Women With Fibromyalgia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Fibromyalgia
• Insomnia
• Chronic Widespread Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-02-07
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2018-11-16
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States