Insomnia Behavioral Therapy for Crohn's Disease

(RISE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Must not be taking: Opioids, Corticosteroids

Disqualifiers: Depression, Anxiety, Pregnancy, others

Compensation: Varies

Number of Visits: 21

Duration: 8 weeks

83 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if behavioral therapy can help people with Crohn's disease who experience insomnia. Researchers seek to discover whether improving sleep can also alleviate other symptoms, such as pain or inflammation. Participants will receive either a specialized behavioral treatment (Cognitive Behavioral Therapy for Insomnia, or CBT-I) or general sleep education and support. This trial suits individuals with mild to moderate Crohn's, who have experienced sleep difficulties for some time, and are stable on their current medications. Access to telehealth (online healthcare services) is also required. As an unphased trial, this study offers participants the chance to contribute to understanding how behavioral therapy can enhance sleep and overall well-being in Crohn's patients.

Will I have to stop taking my current medications?

The trial requires that your sleep and Crohn's disease medications have been stable for at least 3 months, so you should not change them before or during the study.

What prior data suggests that these treatments are safe for people with Crohn's disease?

Research suggests that Cognitive Behavioral Therapy for Insomnia (CBT-I) might be safe for people with Crohn's disease. One study found that CBT-I improved sleep and possibly reduced pain without any serious side effects. Another study showed that CBT-I helped people with other chronic diseases sleep better, indicating it is generally well-tolerated. Although researchers have not widely tested CBT-I in people with inflammatory bowel disease (IBD), research in similar conditions suggests it could be safe. Overall, no strong evidence of harmful effects from CBT-I exists, making it a promising option for treating insomnia in Crohn's disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore non-drug approaches to managing Crohn's disease, focusing on improving sleep quality, which is often disrupted in patients. Unlike standard treatments that primarily target inflammation with medications like corticosteroids or biologics, the Behavioral Treatment aims to tackle insomnia through cognitive and behavioral strategies. This could potentially enhance the overall well-being of patients by addressing sleep-related issues that exacerbate Crohn's symptoms, offering a holistic complement to conventional therapies. The Sleep Education Treatment serves as a comparator to help understand the specific benefits of the behavioral approach.

What evidence suggests that this trial's treatments could be effective for insomnia in Crohn's disease?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I), which participants in this trial may receive as part of the Behavioral Treatment arm, can help people with Crohn's disease sleep better. Studies have found that CBT-I not only improves sleep but may also lessen pain and symptoms of Crohn's. Some evidence suggests it might even lower inflammation, as indicated by reduced levels of CRP, a marker of inflammation. Although researchers have not extensively tested CBT-I in Crohn's patients, it appears promising because it helps with similar issues like chronic pain and depression in people with Inflammatory Bowel Disease (IBD). Overall, CBT-I seems to be a useful approach for dealing with insomnia and related symptoms in Crohn's disease. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for people with mild to moderate Crohn's Disease who have insomnia, as shown by certain scores on sleep and health questionnaires. Participants must not be dealing with severe depression or anxiety, substance abuse, major psychiatric conditions, or using opioids. They should not be pregnant, nursing, smoking, taking steroids, or have specific other medical conditions.

Inclusion Criteria

Mild to moderate CD based on PRO-3 & objective data

Access to internet or cell phone service sufficient for telehealth

My sleep and CD medications have been stable for 3 months.

Exclusion Criteria

Current alcohol or substance abuse

Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder)

Current smoker (tobacco, nicotine)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive insomnia treatment remotely to assess its impact on sleep and Crohn's disease symptoms

8 weeks

Remote monitoring and assessments

Follow-up

Participants are monitored for changes in sleep architecture, sleep efficiency, and Crohn's disease symptoms

26 weeks

Remote assessments at 21 and 34 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Treatment
• Sleep Education Treatment

Trial Overview The study is testing if behavioral treatments and sleep education can help improve sleep in those with Crohn's Disease. It will also look at whether better sleep affects pain or inflammation. The treatment will be delivered remotely via telehealth services.

How Is the Trial Designed?

Group I: Behavioral Treatment Experimental Treatment 1 Intervention

Group II: Sleep Education Treatment Placebo Group 1 Intervention

Behavioral Treatment 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
• Depression
• Inflammation associated with Crohn's disease

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

• Insomnia
• Chronic pain
• Depression
• Inflammation associated with Crohn's disease

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Published Research Related to This Trial

In a study involving 96 cancer survivors, higher levels of social support were linked to better adherence to cognitive-behavioral therapy for insomnia (CBT-I) and improved sleep outcomes, indicating that social support plays a crucial role in treatment success.

Both social support and CBT-I treatment independently contributed to reduced insomnia severity, suggesting that enhancing social support could be a valuable strategy to improve adherence and effectiveness of insomnia interventions in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Support, Insomnia, and Adherence to Cognitive Behavioral Therapy for Insomnia After Cancer Treatment. Kamen, C., Garland, SN., Heckler, CE., et al.[2020]

Cognitive-behavioral therapy for insomnia (CBT-I) was found to be feasible and highly acceptable for patients with inflammatory bowel disease (IBD), with all 10 participants who had insomnia completing the treatment successfully.

After undergoing CBT-I, participants reported significant improvements in sleep quality and continuity, as well as reductions in dysfunctional sleep-related beliefs and IBD disease activity, suggesting that treating insomnia may positively impact overall IBD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot feasibility trial of cognitive-behavioural therapy for insomnia in people with inflammatory bowel disease. Salwen-Deremer, JK., Smith, MT., Aschbrenner, KA., et al.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly reduced insomnia severity and improved sleep quality among 60 college students with Irritable Bowel Syndrome (IBS) over a 4-week period.

Participants receiving CBT-I also experienced decreased IBS symptom severity and improved quality of life, indicating that CBT-I can effectively address both sleep and gastrointestinal issues in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Cognitive Behavioral Therapy for Insomnia among College Students with Irritable Bowel Syndrome: A Randomized Controlled Trial. Yang, YY., Jun, S.[2023]

A stepped-care intervention combining brief behavioral therapy for sleep (BBTS-I) and the medication bupropion (BUP-SR) significantly improved sleep quality and fatigue in adolescents and young adults with Crohn's disease, with 52 out of 68 participants showing marked improvements after 4 weeks of therapy.

While both BBTS-I and the combination of BBTS-I with BUP-SR led to further improvements in sleep and fatigue symptoms after 8 weeks, the addition of BUP-SR did not result in significantly greater benefits compared to BBTS-I alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Behavioral Therapy and Bupropion for Sleep and Fatigue in Young Adults With Crohn's Disease: An Exploratory Open Trial Study. Hashash, JG., Knisely, MR., Germain, A., et al.[2022]

Cognitive behavior therapy for insomnia (CBT-I) shows moderate to large treatment effects (Cohen's d range of 0.35-2.2) for patients with insomnia related to various medical and psychiatric conditions, indicating its efficacy beyond primary insomnia.

Improving sleep through CBT-I may also lead to better outcomes in managing comorbid medical and psychological conditions, highlighting the need for further research on adapting CBT-I for specific disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. Smith, MT., Huang, MI., Manber, R.[2022]

A single 4-hour group workshop on cognitive behavioral treatment for insomnia (CBT-I) significantly improved insomnia symptoms in 45 participants, with Insomnia Severity Index scores dropping from an average of 20.09 to 11.89 after one month.

Participants also reported a reduction in sleep aid use, with 80% indicating better sleep quality and 20% achieving remission of insomnia, highlighting the effectiveness of this accessible treatment format.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. Okun, ML., Glidewell, RN.[2023]

Cognitive behavioral therapy for insomnia (CBT-I) is recognized as the first-line treatment for both uncomplicated insomnia and insomnia associated with other chronic disorders, demonstrating its broad efficacy.

This review aims to summarize efficacy data across various clinical and demographic factors and to outline future research and implementation strategies for CBT-I, highlighting its importance in treating sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? Muench, A., Vargas, I., Grandner, MA., et al.[2022]

Cognitive behavioral therapy for insomnia (CBT-I) significantly improves insomnia symptoms, with 36% of patients achieving remission compared to only 16.9% in control groups, indicating its efficacy for those with comorbid conditions.

CBT-I shows medium to large effect sizes for various sleep parameters, such as sleep efficiency and sleep onset latency, and has a small positive effect on comorbid symptoms, particularly benefiting patients with psychiatric conditions more than those with medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. Wu, JQ., Appleman, ER., Salazar, RD., et al.[2022]

In a study of 670 individuals with inflammatory bowel disease (IBD), insomnia was found to be common and significantly associated with increased disability, anxiety, and depression.

The research suggests that symptoms like abdominal pain and mental health issues should lead to screening for insomnia, and cognitive behavioral therapy for insomnia could be an effective treatment option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia is common in inflammatory bowel disease (IBD) and is associated with mental health conditions as well as IBD activity. Barnes, A., Andrews, JM., Mukherjee, S., et al.[2023]

Over 75% of individuals with inflammatory bowel diseases (IBDs) experience sleep disturbances, which can increase the risk of IBD flare-ups, highlighting the need for effective treatment options.

Cognitive Behavioral Therapy for Insomnia (CBT-I) is the gold standard for treating insomnia and has the potential to alleviate related issues such as chronic pain and depression in IBD patients, although its effectiveness specifically in IBD has not yet been studied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia: A Promising Treatment for Insomnia, Pain, and Depression in Patients With IBD. Salwen-Deremer, JK., Siegel, CA., Smith, MT.[2023]

Citations

1. academic.oup.com academic.oup.com/ibdjournal/article/31/Supplement_1/S63/7978609

COGNITIVE BEHAVIORAL THERAPY FOR INSOMNIA MAY ... CBT-I resulted in improved self-reported sleep, pain, and CD symptoms, with a trend toward improved CRP. Results highlight the importance of addressing sleep ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9802437/

Cognitive Behavioral Therapy for Insomnia: A Promising ... Although yet to be studied in IBD, CBT-I reduces a number of IBD-related comorbidities, including chronic pain, depression, and systemic inflammation.

3. academic.oup.com academic.oup.com/ibdjournal/advance-article-abstract/doi/10.1093/ibd/izaf210/8264003

Cognitive Behavioral Therapy for Insomnia May Improve ... This study provides preliminary evidence of efficacy of CBT-I in people with CD. CBT-I improved self-reported sleep and may improve pain and CD ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04132024

Feasibility of Insomnia Tracking and Treatment in IBD This study is a longitudinal clinical trial designed to characterize sleep patterns in individuals with Inflammatory Bowel Disease (IBD) as well as to assess ...

5. bmjopengastro.bmj.com bmjopengastro.bmj.com/content/bmjgast/8/1/e000805.full.pdf

A pilot feasibility trial of cognitive– behavioural therapy for ... Conclusion CBT- I was feasible and acceptable and demonstrated a signal for efficacy in the treatment of insomnia in IBD.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40997125/

Cognitive Behavioral Therapy for Insomnia May Improve ... This study provides preliminary evidence of efficacy of CBT-I in people with CD. CBT-I improved self-reported sleep and may improve pain and ...

7. bmjopengastro.bmj.com bmjopengastro.bmj.com/content/8/1/e000805

A pilot feasibility trial of cognitive–behavioural therapy for ... While cognitive–behavioural therapy for insomnia (CBT-I) is the recommended first-line treatment for chronic insomnia, it is untested in IBD.

8. academic.oup.com academic.oup.com/crohnscolitis360/article/2/3/otaa052/5862396

A Promising Treatment for Insomnia, Pain, and Depression in ... Although yet to be studied in IBD, CBT-I reduces a number of IBD-related comorbidities, including chronic pain, depression, and systemic inflammation.

9. hcplive.com hcplive.com/view/cbt-i-effective-for-insomnia-in-patients-with-chronic-diseases

CBT-I Effective for Insomnia in Patients with Chronic ... CBT-I was linked to significantly improved outcomes for insomnia severity (95% confidence interval [CI], 0.81 – 1.16), moderate effect sizes ...

10. researchgate.net researchgate.net/publication/389578526_COGNITIVE_BEHAVIORAL_THERAPY_FOR_INSOMNIA_MAY_IMPROVE_SLEEP_AND_PAIN_IN_PATIENTS_WITH_CROHN'S_DISEASE_A_WAITLIST_CONTROLLED_PILOT_TRIAL

COGNITIVE BEHAVIORAL THERAPY FOR INSOMNIA ... DISCUSSION CBT-I resulted in improved self-reported sleep, pain, and CD symptoms, with a trend toward improved CRP. Results highlight the ...