Insomnia Behavioral Therapy for Crohn's Disease
(RISE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Dartmouth-Hitchcock Medical Center
Must not be taking: Opioids, Corticosteroids
Disqualifiers: Depression, Anxiety, Pregnancy, others
Trial Summary
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.
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.
12345Is 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.
12678How 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.
125910Eligibility Criteria
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.
+1 more
Exclusion Criteria
Current alcohol or substance abuse
Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder)
Current smoker (tobacco, nicotine)
+10 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Behavioral TreatmentExperimental Treatment1 Intervention
Group II: Sleep Education TreatmentPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dartmouth-Hitchcock Medical CenterLebanon, NH
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Who Is Running the Clinical Trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
References
A pilot feasibility trial of cognitive-behavioural therapy for insomnia in people with inflammatory bowel disease. [2022]Poor sleep is common in inflammatory bowel disease (IBD), associated with worse overall disease course and predominantly attributable to insomnia. While cognitive-behavioural therapy for insomnia (CBT-I) is the recommended first-line treatment for chronic insomnia, it is untested in IBD. It is unclear if CBT-I will be as effective in this group given the extent of night-time symptoms people with IBD experience. Thus, we evaluated the feasibility and preliminary efficacy of CBT-I in IBD.
Cognitive Behavioral Therapy for Insomnia: A Promising Treatment for Insomnia, Pain, and Depression in Patients With IBD. [2023]Over 75% of people with active inflammatory bowel diseases (IBDs) report sleep disturbances, which heighten risk for IBD relapse and flares. Despite mounting evidence for sleep disturbances in IBD, discussion of treatment is severely limited. The most common sleep disturbance, insomnia, occurs in over 50% of adults with chronic health conditions. Herein we describe the gold standard treatment for insomnia, Cognitive Behavioral Therapy for Insomnia (CBT-I). Although yet to be studied in IBD, CBT-I reduces a number of IBD-related comorbidities, including chronic pain, depression, and systemic inflammation. We describe treatment with CBT-I, the impact of CBT-I on these comorbidities, and recommendations for providers.
Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. [2023]: Cognitive behavioral treatment for insomnia (CBT-I) is the first line of treatment for insomnia. However, the expanded use of CBT-I is limited by the number of specialty-trained clinicians in addition to the duration and cost of individual treatment sessions. One viable option is a single-session educational group format delivered by a trained health educator.
Social Support, Insomnia, and Adherence to Cognitive Behavioral Therapy for Insomnia After Cancer Treatment. [2020]While cognitive-behavioral therapy for insomnia (CBT-I) has been shown to be efficacious in treating cancer survivors' insomnia, 30-60% of individuals have difficulty adhering to intervention components. Psychosocial predictors of adherence and response to CBT-I, such as social support, have not been examined in intervention studies for cancer survivors.
Insomnia is common in inflammatory bowel disease (IBD) and is associated with mental health conditions as well as IBD activity. [2023]Insomnia is common in people with chronic medical conditions, such as inflammatory bowel disease (IBD), and is readily treatable through cognitive behavioral therapy for insomnia. This study aimed to describe the associations with insomnia in people with IBD and its relationship to IBD-related disability.
Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]Insomnia is a pervasive problem for many patients suffering from medical and psychiatric conditions. Even when the comorbid disorders are successfully treated, insomnia often fails to remit. In addition to compromising quality of life, untreated insomnia may also aggravate and complicate recovery from the comorbid disease. Cognitive behavior therapy for insomnia (CBT-I) has an established efficacy for primary insomnia, but less is known about its efficacy for insomnia occurring in the context of medical and psychiatric conditions. The purpose of this article is to present a rationale for using CBT-I in medical and psychiatric disorders, review the extant outcome literature, highlight considerations for adapting CBT-I procedures in specific populations, and suggest directions for future research. Outcome studies were identified for CBT-I in mixed medical and psychiatric conditions, cancer, chronic pain, HIV, depression, posttraumatic stress disorder, and alcoholism. Other disorders discussed include: bipolar disorder, eating disorders, generalized anxiety, and obsessive compulsive disorder. The available data demonstrate moderate to large treatment effects (Cohen's d, range=0.35-2.2) and indicate that CBT-I is a promising treatment for individuals with medical and psychiatric comorbidity. Although the literature reviewed here is limited by a paucity of randomized, controlled studies, the available data suggest that by improving sleep, CBT-I might also indirectly improve medical and psychological endpoints. This review underscores the need for future research to test the efficacy of adaptations of CBT-I to disease specific conditions and symptoms.
Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. [2022]Cognitive behavioral therapy for insomnia (CBT-I) is the most prominent nonpharmacologic treatment for insomnia disorders. Although meta-analyses have examined primary insomnia, less is known about the comparative efficacy of CBT-I on comorbid insomnia.
We know CBT-I works, now what? [2022]Cognitive behavioral therapy for insomnia (CBT-I) has been shown to be efficacious and now is considered the first-line treatment for insomnia for both uncomplicated insomnia and insomnia that occurs comorbidly with other chronic disorders (comorbid insomnia). The purposes of this review are to provide a comprehensive summary of the efficacy data (for example, efficacy overall and by clinical and demographic considerations and by CBT-I formulation) and to discuss the future of CBT-I (for example, what next steps should be taken in terms of research, dissemination, implementation, and practice).
Brief Behavioral Therapy and Bupropion for Sleep and Fatigue in Young Adults With Crohn's Disease: An Exploratory Open Trial Study. [2022]Sleep disturbances and fatigue are common symptoms amongst patients with Crohn's disease (CD). The aim of this study was to test the feasibility and effects of a pragmatic, stepped-care intervention for the treatment of poor sleep quality and fatigue in adolescents and young adults with CD.
The Effects of Cognitive Behavioral Therapy for Insomnia among College Students with Irritable Bowel Syndrome: A Randomized Controlled Trial. [2023]The aim of the study was to develop and evaluate cognitive behavioral therapy for insomnia (CBT-I) among college students with irritable bowel syndrome (IBS). We randomly assigned 60 college students with IBS comorbid insomnia to the experimental group who received CBT-I for 90 min once a week for 4 weeks and the control (non-CBT-I) group. Participants completed self-report measures of insomnia severity, pre-sleep arousal, sleep-related dysfunctional cognitions, maladaptive sleep habits, IBS symptom severity and IBS quality of life (QOL) at baseline, after intervention, and at 3-month follow-up. Sleep pattern, GI symptoms during sleep and Interleukin-6 (IL-6) and C-Reaction Protein (CRP) were measured at baseline and after intervention. The experimental group showed significant decreases in insomnia severity, sleep onset latency, total time in bed, pre-sleep arousal, GI symptoms during sleep, sleep-related dysfunctional cognitions, maladaptive sleep habits, and IBS symptom severity, compared with the control group. This group also showed significant increases in sleep efficiency and IBS QOL compared with the control group. No significant differences were observed between the levels of IL-6 and CRP of both groups. CBT-I for college students with comorbid IBS and insomnia was effective in reducing insomnia, IBS symptom severity, and IBS QOL.