Sleep and Pain Interventions in Women With Fibromyalgia (NCT03744156) | Clinical Trial Compass
CompletedNot Applicable
Sleep and Pain Interventions in Women With Fibromyalgia
United States131 participantsStarted 2019-02-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* female
* 18+ years of age
* willing to be randomized
* can read and understand English
* diagnosed with Fibromyalgia and insomnia
* no prescript or over the counter pain or sleep medicaments for 1+ month
Exclusion Criteria:
* unable to provide informed consent
* cognitive impairment
* sleep disorder other than insomnia (i.e., sleep apnea, periodic limb movement disorder
* bipolar or seizure disorder
* other major psychopathology (other than depression or anxiety)
* psychotropic or other medications that alter pain or sleep
* participation in non-pharmacological treatment (including CBT) for pain, sleep, or mood outside current trial
* internal metal objects or electrical devices
* pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Self-Reported Bedtime, Wake time, Sleep Onset Latency, Wake After Sleep Onset, Sleep Quality on the Daily Diaries
Timeframe: baseline to follow-up (approximately 60 weeks)
2
Change in Insomnia Severity Index (ISI)
Timeframe: baseline to follow-up (approximately 60 weeks)
3
Change in Peripheral Arousal
Timeframe: baseline to follow-up (approximately 60 weeks)
4
Change in Perceived Stress Scale
Timeframe: baseline to follow-up (approximately 60 weeks)
5
Change in Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
Timeframe: baseline to follow-up (approximately 60 weeks)
6
Change in Pain Catastrophizing Scale
Timeframe: baseline to follow-up (approximately 60 weeks)
7
Change in self-reported ratings of Pain Sensitivity and Pain Unpleasantness on Daily Diaries