Improving Sleep for Chronic Pain

Overseen By Christina S McCrae, 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

Trial Summary

What is the purpose of this trial?

The goal of this study is to test two behavioral interventions for chronic insomnia in individuals with chronic pain and use prescribed opioid medication to treat their chronic pain.

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 data supports the effectiveness of the treatment CBT-I for improving sleep in patients with chronic pain?

Research shows that CBT-I (Cognitive Behavioral Therapy for Insomnia) can lead to meaningful improvements in sleep for people with both insomnia and chronic pain. While the effects on pain are less consistent, CBT-I has been found to improve sleep quality and duration, even in the presence of ongoing pain. ^{1 2 3 4 5}

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

Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered safe and does not have the risks associated with sleeping medications, such as tolerance or adverse effects. ^{6 7 8 9 10}

How is CBT-I treatment different from other treatments for chronic pain?

CBT-I (Cognitive Behavioral Therapy for Insomnia) is unique because it focuses on improving sleep habits and changing negative thoughts about sleep, which can lead to better sleep quality and efficiency in people with chronic pain. Unlike other treatments that may focus directly on pain relief, CBT-I targets insomnia, which is a common issue in chronic pain patients, and has shown to improve sleep and sometimes pain-related functioning. ^{1 3 4 8 11}

Research Team

Christina S McCrae, PhD

Principal Investigator

University of South Florida

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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) 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) 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 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) 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]

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) 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) 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]

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]

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]

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]

References

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

The durability of cognitive behavioral therapy for insomnia in patients with chronic pain. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The efficacy of cognitive-behavioral therapy for insomnia in patients with chronic pain. [2021]

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

Cognitive-Behavioral Therapy for Comorbid Insomnia and Chronic Pain. [2022]

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

Exploring the Meaning of Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Pain. [2021]

5. England 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. [2022]

6. England 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). [2021]

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

Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. [2022]

8. England 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. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioural therapy for primary insomnia: effectiveness in a clinical setting]. [2018]

10. England 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. [2020]

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

Cognitive-behavioral treatment of insomnia secondary to chronic pain. [2019]