Sleep Interventions for Fibromyalgia

(SPIN-II Trial)

Overseen By Austin D Ohley, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Must not be taking: Psychotropics, Pain meds, Sleep meds

Disqualifiers: Cognitive impairment, Sleep apnea, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

130 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any pain or sleep medications for at least one month before joining the trial.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I) and Sleep Hygiene Education (SHE) for fibromyalgia?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improves sleep, reduces fatigue, and alleviates anxiety and depression in fibromyalgia patients compared to Sleep Hygiene Education (SHE), which mainly improves subjective sleep quality. Additionally, combined CBT approaches focusing on both pain and insomnia have shown meaningful improvements in sleep quality and efficiency. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Insomnia (CBT-I) safe for humans?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally considered safe for humans, as it is a non-drug treatment that focuses on changing sleep habits and behaviors. Studies have shown it can improve sleep and reduce symptoms in people with fibromyalgia without significant adverse effects. ^{1 2 3 4 5}

How is Cognitive Behavioral Treatment-Insomnia (CBT-I) different from other treatments for fibromyalgia?

Cognitive Behavioral Treatment-Insomnia (CBT-I) is unique because it specifically targets insomnia, a common issue in fibromyalgia, and has been shown to improve sleep quality, fatigue, and mood more effectively than sleep hygiene education alone. Unlike other treatments that may focus solely on pain, CBT-I addresses the psychological aspects of insomnia, which can help alleviate other fibromyalgia symptoms. ^{1 2 3 5 6}

Research Team

Christina McCrae, PhD

Principal Investigator

University of Missouri-Columbia

Eligibility Criteria

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.

Inclusion Criteria

You must be able to read and comprehend English.

You have been diagnosed with both fibromyalgia and insomnia.

You are a woman.

Exclusion Criteria

You have a mental health condition other than depression or anxiety that is significant.

unable to provide informed consent

You have problems with thinking or memory.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cognitive Behavioral Treatment-Insomnia or Sleep Hygiene Education over 8 sessions

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 and 12 months

12 months

Treatment Details

Interventions

• Cognitive Behavioral Treatment-Insomnia
• Sleep Hygiene Education

Trial Overview 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.

Participant Groups

Group I: Sleep Hygiene Education Experimental Treatment 1 Intervention

Sleep Hygiene Education. 8 Session treatment focusing on sleep hygiene education.

Group II: Cognitive Behavioral Treatment-Insomnia Experimental Treatment 1 Intervention

Cognitive Behavioral Treatment-Insomnia. 8 Session treatment focusing on behavior and cognitions related to sleep and pain.

Cognitive Behavioral Treatment-Insomnia is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive Behavioral Therapy for Insomnia for:

• Insomnia
• Chronic Pain Management
• Fibromyalgia

Approved in European Union as Cognitive Behavioral Treatment-Insomnia for:

• Insomnia
• Chronic Pain Management
• Fibromyalgia

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

In a trial involving 64 women with fibromyalgia and insomnia, cognitive-behavioral therapy for insomnia (CBT-I) led to significant improvements in sleep quality, fatigue, daily functioning, pain catastrophizing, anxiety, and depression compared to a sleep hygiene education program.

The CBT-I group showed greater overall improvements in various clinical symptoms than the sleep hygiene group, highlighting its effectiveness as part of a comprehensive treatment plan for fibromyalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for insomnia and sleep hygiene in fibromyalgia: a randomized controlled trial. Martínez, MP., Miró, E., Sánchez, AI., et al.[2021]

In a study of 39 female patients with fibromyalgia and insomnia, combined cognitive-behavioral therapy (CBT-C) focusing on both pain and insomnia led to significant improvements in sleep quality and efficiency compared to standard CBT focused only on pain (CBT-P).

Participants receiving CBT-C experienced better sleep outcomes, including increased time in deep sleep (Stage 4) and improved self-perceived sleep quality, highlighting the effectiveness of addressing both pain and sleep issues together.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined cognitive-behavioral therapy for fibromyalgia: Effects on polysomnographic parameters and perceived sleep quality. Prados, G., Miró, E., Martínez, MP., et al.[2020]

Cognitive-behavioral therapy (CBT) significantly improved sleep in fibromyalgia patients, with nearly 50% reduction in nocturnal wake time, compared to only 20% and 3.5% reductions in those receiving sleep hygiene instructions and usual care, respectively.

CBT also led to a higher percentage of patients meeting strict sleep improvement criteria (57% of CBT recipients) compared to those receiving sleep hygiene (17%) or usual care (0%), indicating its efficacy as a treatment for insomnia in fibromyalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial. Edinger, JD., Wohlgemuth, WK., Krystal, AD., et al.[2015]

Cognitive Behavioral Therapy for Pain (CBT-P) significantly reduced the number of days patients with fibromyalgia and insomnia used sleep medications immediately after treatment, although this effect did not persist at the 6-month follow-up.

Cognitive Behavioral Therapy for Insomnia (CBT-I) and CBT-P did not show significant effects on reducing opioid medication use, suggesting they may not be effective as standalone treatments for opioid dependence in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cognitive behavioural therapy on sleep and opioid medication use in adults with fibromyalgia and insomnia. McCrae, CS., Curtis, AF., Miller, MB., et al.[2021]

Cognitive Behavioral Therapy for Insomnia (CBT-I) and Cognitive Behavioral Therapy for Pain (CBT-P) both improved self-reported insomnia symptoms in patients with fibromyalgia, with CBT-I showing larger and more sustained effects over time.

While neither treatment significantly improved pain or mood overall, about one-third of participants experienced clinically meaningful pain reductions, particularly with CBT-I at the 6-month follow-up, suggesting it may offer better long-term benefits for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral treatments for insomnia and pain in adults with comorbid chronic insomnia and fibromyalgia: clinical outcomes from the SPIN randomized controlled trial. McCrae, CS., Williams, J., Roditi, D., et al.[2023]

Cognitive Behavioral Therapy for Insomnia (CBT-I) led to greater reductions in neural activation in response to pain in fibromyalgia patients compared to Cognitive Behavioral Therapy for Pain (CBT-P), indicating that improving sleep may significantly influence pain processing in the brain.

Improvements in total wake time and total sleep time, rather than pain intensity, were associated with decreased neural activation in response to pain, suggesting that better sleep quality plays a crucial role in managing pain in fibromyalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural activation changes in response to pain following cognitive behavioral therapy for patients with comorbid fibromyalgia and insomnia: a pilot study. McCrae, CS., Craggs, JG., Curtis, AF., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for insomnia and sleep hygiene in fibromyalgia: a randomized controlled trial. [2021]

2. Spain pubmed.ncbi.nlm.nih.gov

Combined cognitive-behavioral therapy for fibromyalgia: Effects on polysomnographic parameters and perceived sleep quality. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Effect of cognitive behavioural therapy on sleep and opioid medication use in adults with fibromyalgia and insomnia. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavioral treatments for insomnia and pain in adults with comorbid chronic insomnia and fibromyalgia: clinical outcomes from the SPIN randomized controlled trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Neural activation changes in response to pain following cognitive behavioral therapy for patients with comorbid fibromyalgia and insomnia: a pilot study. [2023]