Improving Sleep for Chronic Pain

Overseen By Britani Holland, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Must be taking: Opioids

Must not be taking: Psychotropics, Beta-blockers

Disqualifiers: Cognitive impairment, Sleep apnea, Bipolar, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

165 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to assist individuals who struggle with sleep due to chronic pain and use opioids for pain management. One group will participate in an online program called CBT-I (Cognitive Behavioral Therapy for Insomnia), which includes weekly sessions to enhance sleep over eight weeks. The other group will continue their usual sleep and pain care. This trial suits those who have used opioid medication regularly for over a month, experience chronic pain and insomnia, and wish to reduce or stop opioid use. As an unphased trial, it offers a unique opportunity to explore new methods for improving sleep and reducing opioid use.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it allows medications prescribed for pain or sleep. You should have a written agreement from your doctor if you are on opioid medication.

What prior data suggests that these behavioral interventions are safe for individuals with chronic pain?

A previous study demonstrated that cognitive behavioral therapy for insomnia (CBT-I) is safe and effective. Research suggests it improves sleep for individuals with both insomnia and chronic pain. Participants typically find CBT-I manageable, with few negative side effects reported. Studies also show that online or app-based versions of CBT-I are as effective and safe as in-person sessions. This makes CBT-I a reliable choice for improving sleep without added risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Cognitive Behavioral Therapy for Insomnia (CBT-I) to improve sleep in individuals with chronic pain because it offers a new approach compared to traditional treatments like medication. Unlike medications that often focus on symptom relief, CBT-I aims to tackle the root causes of sleep issues by changing sleep habits and thought patterns. This therapy is delivered online, making it accessible and convenient for patients, removing barriers like travel and scheduling conflicts. Additionally, CBT-I is non-pharmacological, reducing the risk of side effects and dependency associated with sleep medications.

What evidence suggests that CBT-I is effective for improving sleep in individuals with chronic pain?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) improves sleep quality. Studies have found that CBT-I makes falling asleep easier and enhances overall sleep patterns. One study discovered that CBT-I works as well as sleep medication but with fewer side effects and longer-lasting benefits. Additionally, CBT-I has been shown to reduce insomnia and improve sleep quality for people with chronic pain. In this trial, participants will receive either 8 weeks of online CBT-I or continue with their standard treatment for sleep and pain. These findings suggest that CBT-I could be a promising treatment for those with both long-term insomnia and chronic pain. ^{4 6 7 8 9}

Who Is on the Research Team?

Britani Holland, PhD

Principal Investigator

University of South Florida

Christina S McCrae, PhD

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

This trial is for people who have chronic pain and insomnia, and are currently using prescribed opioids. It aims to help them sleep better and reduce their opioid use.

Inclusion Criteria

Willing to be randomized

Can read and understand English

I want to reduce or stop using opioids.

Exclusion Criteria

I have a pinched nerve in my lower back.

I have a condition affecting my spine.

Unable to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins

8 weeks

8 visits (virtual)

Tapered Withdrawal

Participants undergo a gradual tapering of opioid medication with motivational interviewing and check-ins

4-6 weeks

Follow-up

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

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CBT-I

Trial Overview The study is testing two approaches: one where patients continue their usual treatment, another where they gradually reduce opioid use (tapered withdrawal), and a third that uses Cognitive Behavioral Therapy for Insomnia (CBT-I).

How Is the Trial Designed?

Group I: Treatment as usual Experimental Treatment 2 Interventions

Continuation of standard treatment for sleep and pain for 8 weeks, followed by tapered withdrawal and motivational interviewing and check-ins.

Group II: Experimental Experimental Treatment 2 Interventions

8 weeks of online CBT-I (1 session/week for 1 hour), followed by tapered withdrawal and motivational interviewing and check-ins.

CBT-I is already approved in United States, European Union, Canada for the following indications:

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

• Chronic insomnia
• Insomnia in individuals with chronic pain
• Insomnia in individuals with psychiatric comorbidities

Approved in European Union as Cognitive Behavioural Therapy for Insomnia for:

• Chronic insomnia
• Insomnia in individuals with chronic pain
• Insomnia in individuals with psychiatric comorbidities

Approved in Canada as Cognitive Behavioral Therapy for Insomnia for:

• Chronic insomnia
• Insomnia in individuals with chronic pain
• Insomnia in individuals with psychiatric comorbidities

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

The internet-based cognitive-behavioral therapy for insomnia (CBT-I) program significantly reduced symptoms of depression, anxiety, and insomnia within just 4 weeks, with these improvements lasting for over 18 months in a study of 1,149 adults.

While the CBT-I program effectively lowered depressive symptoms long-term, its impact on suicidal ideation was only temporary, indicating a need for additional support for individuals at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trajectories of change and long-term outcomes in a randomised controlled trial of internet-based insomnia treatment to prevent depression. Batterham, PJ., Christensen, H., Mackinnon, AJ., et al.[2020]

Cognitive behavioral therapy for insomnia (CBT-I) is a safe and effective alternative to sleeping medications, but many patients are unaware or reluctant to engage with it, preferring sedative hypnotics instead.

Focus groups with 29 Veterans revealed that patients prefer a stepped-care approach to CBT-I, starting with self-management tools and progressing to provider-delivered therapy if necessary, highlighting the need for multiple outreach efforts and delivery options to increase engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). Koffel, E., Branson, M., Amundson, E., et al.[2021]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improved sleep quality, sleep onset, and sleep efficiency in 76 patients with primary insomnia over a 6-week group course in a clinical setting.

CBT-I also led to reductions in medication use and improvements in patients' overall health and cognitive functioning, highlighting its effectiveness beyond just sleep improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioural therapy for primary insomnia: effectiveness in a clinical setting]. Van Houdenhove, L., Buyse, B., Gabriels, L., et al.[2018]

Cognitive-behavioral therapy for insomnia (CBT-I) has been shown to significantly improve sleep symptoms in patients who suffer from both insomnia and chronic pain, based on a review of six randomized controlled trials.

While the effects of CBT-I on pain severity are inconsistent, improvements in functional measures related to pain have been observed, suggesting that CBT-I may help patients manage their overall well-being better.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-Behavioral Therapy for Comorbid Insomnia and Chronic Pain. Finan, PH., Buenaver, LF., Coryell, VT., et al.[2022]

A randomized controlled trial with 60 participants demonstrated that cognitive-behavioral therapy (CBT) significantly improved sleep outcomes in individuals with insomnia related to chronic pain, including better sleep onset, reduced wake time, and improved sleep quality.

At a 3-month follow-up, participants who received CBT maintained most of their sleep improvements, providing strong evidence for CBT as an effective treatment for insomnia associated with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral treatment of insomnia secondary to chronic pain. Currie, SR., Wilson, KG., Pontefract, AJ., et al.[2019]

Cognitive Behavioral Therapy for insomnia (CBT-i) is an effective first-line treatment for chronic insomnia, showing significant improvements in sleep onset latency (SOL) by about 19 minutes and wake after sleep onset (WASO) by about 26 minutes based on a review of 20 studies involving 1162 participants.

The benefits of CBT-i, which includes techniques like cognitive therapy and sleep hygiene, appear to be sustained over time, and importantly, no adverse effects were reported, making it a safe alternative to pharmacological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Trauer, JM., Qian, MY., Doyle, JS., et al.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) was effective in improving total sleep time by an average of 23 minutes over six months in patients with chronic pain, despite ongoing pain issues.

The study involved 28 participants (19 receiving CBT-I and 9 in a control group) and showed that while there were no significant differences in pain, mood, or function immediately after treatment, the benefits for sleep persisted and even improved over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The durability of cognitive behavioral therapy for insomnia in patients with chronic pain. Jungquist, CR., Tra, Y., Smith, MT., et al.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) was found to be significantly more effective than control treatments for improving sleep, pain, disability, and depression in individuals with comorbid insomnia and chronic pain, based on a meta-analysis of 16 randomized controlled trials involving 1094 participants.

Cognitive Behavioral Therapy for Pain (CBT-P) did not show significant effectiveness compared to control for any outcomes, suggesting that CBT-I may be the preferred treatment for this population, although the results should be interpreted cautiously due to small sample sizes and potential biases in the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effectiveness of cognitive behavioral therapy for insomnia, cognitive behavioral therapy for pain, and hybrid cognitive behavioral therapy for insomnia and pain in individuals with comorbid insomnia and chronic pain: A systematic review and network meta-analysis. Enomoto, K., Adachi, T., Fujino, H., et al.[2022]

A qualitative study involving 17 veterans with chronic pain and insomnia revealed that while changing sleep habits during cognitive behavioral therapy for insomnia (CBT-I) was challenging, patients did not face significant pain-related barriers to adherence.

Patients reported improvements in sleep, mood, energy, and social interactions after CBT-I, highlighting its effectiveness as a personalized treatment for insomnia in chronic pain contexts, despite minimal changes in pain intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Meaning of Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Pain. Koffel, E., Amundson, E., Wisdom, JP.[2021]

Cognitive-behavioral therapy for insomnia (CBT-I) significantly improved sleep quality in patients with chronic neck and back pain, leading to reduced sleep latency and increased sleep efficiency over an 8-week period.

CBT-I also helped decrease the interference of pain in daily activities, although it did not significantly affect overall mood or pain severity, indicating its specific benefits for sleep and functional outcomes in chronic pain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of cognitive-behavioral therapy for insomnia in patients with chronic pain. Jungquist, CR., O'Brien, C., Matteson-Rusby, S., et al.[2021]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improves sleep quality and reduces depressive symptoms in patients with comorbid insomnia and chronic non-cancer pain, based on a meta-analysis of 12 studies involving 762 participants.

At post-treatment, CBT-I showed a strong effect on sleep (SMD = 0.89) and a moderate effect on pain (SMD = 0.20), with sustained improvements in sleep quality observed up to 12 months after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia in patients with chronic pain - A systematic review and meta-analysis of randomized controlled trials. Selvanathan, J., Pham, C., Nagappa, M., et al.[2022]

Citations

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Cognitive Behavioral Therapy for Insomnia (CBT-I): A Primer CBT-I is a multi-component treatment for insomnia that targets difficulties with initiating and/or maintaining sleep. Standard treatment is delivered over the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6796223/

Cognitive-Behavioral Therapy for Insomnia: An Effective ... CBT-i produces results that are equivalent to sleep medication, with no side effects, fewer episodes of relapse, and a tendency for sleep to continue to improve ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822153

Cognitive Behavioral Therapy for Insomnia in Pain ... CBTi-BEPM was, consistently over time and analyses, more effective than BEPM only for improving insomnia severity, sleep quality, beliefs about sleep, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S138994572500156X

Effectiveness of group-delivered cognitive behavioural ... Results from a meta-analysis showed that group-delivered CBT-I led to improved sleep quality and better sleep, especially regarding sleep onset latency, sleep ...

5. academic.oup.com academic.oup.com/sleep/article/47/10/zsae177/7726190

Should cognitive behavioral therapy for insomnia be ... Collectively, these data support the hypothesis that improvements in sleep through CBT-I can meaningfully reduce chronic pain.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40817235/

study protocol for a randomized controlled trial Cognitive behavioral therapy for insomnia (CBT-I) is an effective and safe first-line treatment; however, access remains a major barrier to ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2214782924000745

Internet-based cognitive behavioural therapy for insomnia ... This study aimed to evaluate the feasibility and efficacy of internet-based CBT-i and to explore potential mechanisms underlying treatment outcomes.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4248667/

Cognitive-Behavioral Therapy for Comorbid Insomnia and ... The data suggest that CBT-I for patients with comorbid insomnia and chronic pain produces clinically meaningful improvements in sleep symptoms. Effects on pain ...

9. 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 ...