Sleep Interventions for Fibromyalgia

(SPIN-II Trial)

Overseen By Christina McCrae, PhD

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

131 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different sleep treatments can help women with fibromyalgia and insomnia manage pain. Researchers compare two approaches: cognitive behavioral therapy for insomnia (Cognitive Behavioral Treatment-Insomnia) and sleep hygiene education. The goal is to understand how sleep affects pain and brain function in women with fibromyalgia. Women diagnosed with both fibromyalgia and insomnia who haven't used pain or sleep medications for at least a month might be good candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance sleep and pain management for 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I) is generally safe and manageable. Studies have found that it improves sleep quality and reduces issues like pain, anxiety, and depression. Participants in these studies reported no serious side effects, indicating it is a low-risk way to enhance sleep.

Similarly, learning about good sleep habits, known as sleep hygiene education, is also safe. It improves sleep quality and can ease pain and depression in people with fibromyalgia. Like CBT-I, sleep hygiene education carries no significant risks or negative effects.

Both treatments do not involve medication, making them safer options for those concerned about drug side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments in this trial because they offer non-drug approaches to managing fibromyalgia symptoms, which could be a game-changer for patients. Cognitive Behavioral Treatment for Insomnia (CBT-I) focuses on changing behaviors and thoughts around sleep and pain, providing tools that could help patients manage fibromyalgia symptoms more effectively. On the other hand, Sleep Hygiene Education emphasizes teaching good sleep practices, which can improve overall sleep quality. Both methods aim to address the sleep problems often associated with fibromyalgia, offering hope for relief without the side effects of medication.

What evidence suggests that this trial's treatments could be effective for fibromyalgia?

Studies have shown that Cognitive Behavioral Therapy for Insomnia (CBT-I), one of the treatments in this trial, effectively improves sleep quality and reduces pain in people with fibromyalgia. Research indicates that CBT-I leads to better sleep outcomes compared to medications and also alleviates anxiety and depression symptoms. This trial also studies sleep hygiene education, which involves learning habits that promote good sleep. It has improved sleep quality and reduced pain and depression in fibromyalgia patients. Both treatments in this trial show promise for addressing sleep issues in fibromyalgia, with CBT-I offering particularly strong benefits. ^{1 2 4 6 7}

Who Is on the Research Team?

Christina McCrae, PhD

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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 (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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30496533/

Cognitive behavioral treatments for insomnia and pain in ... Conclusions: CBT-I and CBT-P improved self-reported insomnia symptoms. CBT-I prompted improvements of larger magnitude that were maintained.

2. clinicaladvisor.com clinicaladvisor.com/news/cbt-i-improves-sleep-quality-in-fibromyalgia/

CBT-I Outperforms Medications for Improving Sleep in ... Overall, CBT-I may be more effective than pharmacological therapies for improving sleep quality among patients with fibromyalgia.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34297651/

Cognitive behavioral therapy for insomnia (CBT-i) in ... CBT-i was associated with a significant improvement in sleep quality, pain, anxiety, and depression, although these results are retrieved from very few studies.

4. sciencedirect.com sciencedirect.com/science/article/pii/S169726002030020X

Combined cognitive-behavioral therapy for fibromyalgia These authors found that, compared to the control group, the CBT-C group showed significant and positive changes in insomnia symptoms and significant ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/09638288.2021.1954706

Cognitive behavioral therapy for insomnia (CBT-i) in ... CBT-i was associated with a significant improvement in sleep quality, pain, anxiety, and depression, although these results are retrieved from very few studies.

6. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-09013-3

Digitally delivered cognitive behavioral therapy for insomnia ... This study aims to evaluate the effectiveness of a 9-week app-delivered CBT-I intervention, compared to an app-delivered sleep hygiene education ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1087079222000594

Effects of cognitive behavioral therapy for insomnia (CBT-I) ... The effects of cognitive behavioral therapy for insomnia (CBT-I) have consistently been shown to improve insomnia symptoms and other health-related outcomes.