Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-02-28 @ 3:53 AM
Study NCT ID:
NCT03744156
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2018-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep and Pain Interventions in Women With Fibromyalgia
Sponsor:
University of Missouri-Columbia
Organization:
Study Overview
Official Title:
Impact of CBT for Insomnia on Pain Symptoms and Central Sensitization in Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPIN-II
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01NR017168-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |