CLINICAL TRIAL

Cognitive Behavioral Therapy for Insomnia for Ileocolitis

Recruiting · 18+ · All Sexes · Lebanon, NH

This study is evaluating whether Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve sleep in people with Crohn's disease.

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About the trial for Ileocolitis

Eligible Conditions
Inflammation · Parasomnias · Sleep Disturbance · Pain · Crohn Disease · Insomnia · Dyssomnias

Treatment Groups

This trial involves 2 different treatments. Cognitive Behavioral Therapy For Insomnia is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Cognitive Behavioral Therapy for Insomnia
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia
2013
Completed Phase 3
~1120

Side Effect Profile for Antidepressant + Cognitive Behavioral

Antidepressant + Cognitive Behavioral
Show all side effects
1%
Medically significant event not requiring hospitalization
1%
suicidal ideation and worsening depression
1%
Worsening of known cardiac condition
0%
Severe vaginal bleeding and pain
0%
Asthma
0%
Hematoma R side abdomen
0%
Chest pain in a patient with CAD
Medically significant event not requiring hospitalization
1%
suicidal ideation and worsening depression
1%
Worsening of known cardiac condition
1%
Severe vaginal bleeding and pain
0%
Asthma
0%
Hematoma R side abdomen
0%
Chest pain in a patient with CAD
0%
This histogram enumerates side effects from a completed 2015 Phase 2 & 3 trial (NCT00767624) in the Antidepressant + Cognitive Behavioral ARM group. Side effects include: Medically significant event not requiring hospitalization with 1%, suicidal ideation and worsening depression with 1%, Worsening of known cardiac condition with 1%, Severe vaginal bleeding and pain with 0%, Asthma with 0%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Insomnia severity index score of 8 or greater
Sleep onset latency and/or wake after sleep onset of at least 30 minutes
Access to device and internet/cell phone service sufficient for telehealth
Mild to moderate Crohn's disease (as assessed by PRO-3 score)
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From baseline assessment to 1-month post intervention
Screening: ~3 weeks
Treatment: Varies
Reporting: From baseline assessment to 1-month post intervention
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From baseline assessment to 1-month post intervention.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Cognitive Behavioral Therapy for Insomnia will improve 3 primary outcomes and 13 secondary outcomes in patients with Ileocolitis. Measurement will happen over the course of From baseline assessment to 1-month post intervention.

Change in sleep onset latency as measured by ambulatory EEG monitoring
FROM BASELINE ASSESSMENT TO 1-MONTH POST INTERVENTION
Change in sleep onset latency as measured by ambulatory EEG sleep architecture monitoring (sleep profiler)
FROM BASELINE ASSESSMENT TO 1-MONTH POST INTERVENTION
Change in wake after sleep onset as measured by ambulatory EEG monitoring
FROM BASELINE ASSESSMENT TO 1-MONTH POST INTERVENTION
Change in wake after sleep onset as measured by ambulatory EEG sleep architecture monitoring (sleep profiler)
FROM BASELINE ASSESSMENT TO 1-MONTH POST INTERVENTION
Change in time spent in slow wave sleep
FROM BASELINE ASSESSMENT TO 1-MONTH POST INTERVENTION
We will measure percentage of time spent in slow wave sleep during a night's sleep using the Sleep Profiler, an ambulatory EEG sleep monitor
FROM BASELINE ASSESSMENT TO 1-MONTH POST INTERVENTION
Change in behaviorally assessed pain tolerance via the Cold Pressor Test
FROM BASELINE ASSESSMENT TO 1-MONTH POST INTERVENTION
The Cold Pressor Test involves submerging one's non-dominant hand in ice water and rating discomfort at regular, pre-determined intervals. Pain tolerance will be measured based on the total amount of time a participant can keep their hand submerged, with a maximum of 2 minutes.
FROM BASELINE ASSESSMENT TO 1-MONTH POST INTERVENTION
Change in self-reported pain as measured by the Brief Pain Inventory
FROM BASELINE ASSESSMENT TO 1-MONTH POST INTERVENTION
The Brief Pain Inventory will be used to assess pain location, severity, and interference. Pain severity is rated from 0-10 and pain interference is rated from 0-10; higher scores indicate more severe pain and more pain interference.
FROM BASELINE ASSESSMENT TO 1-MONTH POST INTERVENTION
Change in wake after sleep onset as measured by actigraphy
FROM BASELINE ASSESSMENT TO 1-MONTH POST INTERVENTION
Change in wake after sleep onset as measured by actigraphy (actigraph)
FROM BASELINE ASSESSMENT TO 1-MONTH POST INTERVENTION
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Who is running the study

Principal Investigator
J.
Jessica.K.Salwen-Deremer, Principal Investigator
Dartmouth-Hitchcock Medical Center

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can ileocolitis be cured?

The prognosis for functional remission of ileocolitis depends on underlying diagnosis, but most patients will experience functional remission after long-term therapy of 4-8 months. Thus, the aim of the therapy should be not to cure ileocolitis, but to relieve the patient's discomfort and pain, and to enable a quality of life that is as normal as possible.

Anonymous Patient Answer

What are the signs of ileocolitis?

Ileocolitis is not typically associated with typical signs. The ileum may be painful, edematous and erythematous, and diarrhea may be bloody in some. These signs are more present in older patients.

Anonymous Patient Answer

How many people get ileocolitis a year in the United States?

In the United States, over 50% of [ulcerative colitis](https://www.withpower.com/clinical-trials/ulcerative-colitis) and 50% of colitis involving multiple portions of the large intestine can be attributable to sibo. It remains to be determined how often sibo is the cause of ulcerative colitis, how often it may be a contributing factor to colorectal cancer-like symptoms, and the long-term course of disease without surgical intervention.

Anonymous Patient Answer

What causes ileocolitis?

Ileal pouch-anal anastomosis patients have a different risk of pouchitis when compared with ulcerative colitis patients. Ileal pouch-anal anastomosis may also increase the risk of pouch disease.

Anonymous Patient Answer

What is ileocolitis?

Ileocolitis is inflammation of the ileum and jejunum. Although it is often caused by infection with Shiga-like toxin-producing Escherichia coli (STEC), its pathology is not always as severe and is often caused by a number of different infectious agents.\n

Anonymous Patient Answer

What are common treatments for ileocolitis?

There are limited treatments specific to ileocolitis. Antibiotics and fluid intake are often used. There is no medication specifically for ileocolitis. CBT may sometimes be used to help with irritable bowel syndrome symptoms.\n

Anonymous Patient Answer

What is the average age someone gets ileocolitis?

Ileocolitis is a bowel disease in which inflammatory lesions that attack and destroy the lining of the small intestine occur. The average age of onset of Ileocolitis is 46. Symptoms of this condition (abdominal pain or bloating) can include nausea, vomiting and diarrhea. As the disease worsens there can be more serious complications such as diarrhea-predominant IBS, severe hemorrhoids, colorectal cancer, inflammation of the colon or uterus, severe blood loss, or serious intestinal ischemia. A healthcare professional will help you to find the right treatment regimen. Please check the list below to learn more about the disease. https://www.cancer.

Anonymous Patient Answer

What are the common side effects of cognitive behavioral therapy for insomnia?

CBT-I is associated with an array of side effects. Adherence to treatment is crucial to optimize patient outcome and may be necessary to obtain and maintain treatment benefit.

Anonymous Patient Answer

Have there been any new discoveries for treating ileocolitis?

There are still multiple treatments for UC, all of which have limitations in their efficacy and/or toxicity. However, new therapeutic agents have been developed and are being produced that may serve as the next step in combating UC.

Anonymous Patient Answer

What does cognitive behavioral therapy for insomnia usually treat?

Findings from a recent study suggests that cognitive behavioral therapy for insomnia is probably not an effective treatment modality for chronic obstructive sleep apnea, which is not significantly linked with insomnia.

Anonymous Patient Answer

What is the latest research for ileocolitis?

To improve patient outcomes, treatments should be standardized and evidence-based protocols need to be developed. Current therapy is not optimal, although immunosuppression has been the most common treatment since it was introduced in 1978. There are gaps in the knowledge of disease progression, prognosis, and risk of complications. Research continues to uncover the pathophysiology and genetic and environmental factors that could explain ileocolitis.

Anonymous Patient Answer

What are the latest developments in cognitive behavioral therapy for insomnia for therapeutic use?

Effective use of CBT for insomnia is complicated by the requirement for a sleep specialist to assess insomnia and tailor a treatment program to each individual's needs. The role of behavioral treatment in insomnia is expanding as new behavioral techniques and models are developed. These methods provide unique opportunities to develop CBT for insomnia, including more rigorous assessment of insomnia, new behavioral strategies to improve sleep quality and sleep efficiency, techniques to enhance acceptance of CBT as an acceptable therapy for insomnia, and more effective application of cognitive-behavioral principles to improve sleep at home.

Anonymous Patient Answer
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