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?

The purpose of this study is to assess whether the investigators can treat insomnia in people with Crohn's disease, and if insomnia treatment can make other things better, like pain or inflammation.

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.

Is Cognitive Behavioral Therapy for Insomnia (CBT-I) safe for people with Crohn's Disease?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally considered safe for people with various medical and psychiatric conditions, including those with inflammatory bowel disease (IBD), which is related to Crohn's Disease. It is a non-drug treatment that has been shown to improve sleep and may also help with related issues like pain and depression. ^{1 2 3 4 5}

How is the treatment for insomnia in Crohn's disease different from other treatments?

This treatment uses Cognitive Behavioral Therapy for Insomnia (CBT-I), which is a non-drug approach focusing on changing sleep habits and thoughts about sleep. Unlike typical drug treatments, CBT-I addresses insomnia by improving sleep patterns and reducing related issues like pain and depression, which can be particularly beneficial for people with Crohn's disease. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment for insomnia in Crohn's Disease?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective in treating insomnia and related issues like pain and depression in people with inflammatory bowel disease (IBD), which includes Crohn's Disease. Although not yet specifically studied in Crohn's Disease, CBT-I has shown promise in improving sleep and reducing symptoms in similar conditions. ^{1 2 6 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

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

A pilot feasibility trial of cognitive-behavioural therapy for insomnia in people with inflammatory bowel disease. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia: A Promising Treatment for Insomnia, Pain, and Depression in Patients With IBD. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. [2023]

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

Social Support, Insomnia, and Adherence to Cognitive Behavioral Therapy for Insomnia After Cancer Treatment. [2020]

5. Korea (South) 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. [2023]

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

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]

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

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? [2022]

9. United States 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. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

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