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Completed

NCT Number: NCT05034159

CBT-I for Sleep, Pain, and Inflammation in Crohn's Disease

People with Crohn's disease often suffer from sleep problems. Long term, sleep problems may lead to more flares of Crohn's disease or other complications. In general, people with Crohn's disease also report that sleep problems can worsen symptoms of Crohn's disease the next day. In people with other medical problems, research has also shown that having sleep problems can make other things worse, such as pain and inflammation. In this study, the researchers want to understand the treatment of sleep problems in people with Crohn's disease, and what else might improve if sleep gets better. This study will use Cognitive Behavioral Therapy for Insomnia (CBT-I) to treat insomnia symptoms. CBT-I is the recommended treatment for insomnia and has been shown to improve sleep problems, pain, and inflammation in other groups of people. If this study is successful, it will contribute to understanding how to treat insomnia in people with Crohn's disease and how sleep impacts pain and inflammation. Long term, this information will be helpful in understanding how best to take care of people with Crohn's disease.

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Key information

Conditions

Crohn Disease Digestive System Diseases Dyssomnias Gastroenteritis Gastrointestinal Diseases Inflammation Inflammatory Bowel Diseases Insomnia Intestinal Diseases Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Parasomnias Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Disturbance Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mild to moderate Crohn's disease (as assessed by PRO-3 score)
  • 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

Exclusion criteria

  • PHQ-9 score of 20 or greater
  • GAD-7 score of 20 or greater
  • Unstable major psychiatric condition
  • Current alcohol or substance abuse
  • Current narcotic use for pain control
  • Current systemic corticosteroid use
  • Current pregnancy or nursing
  • Ileostomy or colostomy
  • Diagnosis of seizure disorder
  • Diagnosis of sleep apnea or positive STOP-Bang screen
  • Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RLSq screen
  • Night shift, rotating shift work, or frequent travel outside of primary time zone

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

Same as is described previously.

Primary outcomes

  1. Change in insomnia symptoms as measured by the Insomnia Severity Index

    Time frame: From baseline assessment to 1-month post intervention

    The Insomnia Severity Index (ISI) is a self-report questionnaire designed to measure severity of insomnia. The ISI is made up of 7 items on insomnia symptoms and related impairments and total scores range from 0-28. Higher scores are indicative of greater insomnia symptoms.

  2. Change in diary-based sleep onset latency

    Time frame: From baseline assessment to 1-month post intervention

    A weekly average of self-reported time it takes to fall asleep each night, derived from a self-reported sleep diary

  3. Change in diary-based wake after sleep onset

    Time frame: From baseline assessment to 1-month post intervention

    A weekly average of self-reported time spent awake in the middle of each night, derived from a self-reported sleep diary

Secondary outcomes

  1. Change in sleep efficiency based on diary

    Time frame: From baseline assessment to 1-month post intervention

    Change in sleep efficiency (total sleep time / time in bed), derived from a self-reported sleep diary

  2. Change in sleep efficiency based on actigraphy

    Time frame: From baseline assessment to 1-month post intervention

    Change in sleep efficiency (total sleep time / time in bed) as measured by actigraphy (actigraph)

  3. Change in diary sleep efficiency based on ambulatory EEG monitoring

    Time frame: From baseline assessment to 1-month post intervention

    Change in sleep efficiency (total sleep time / time in bed) as measured by ambulatory EEG sleep architecture monitoring (sleep profiler)

  4. Change in sleep onset latency as measured by actigraphy

    Time frame: From baseline assessment to 1-month post intervention

    Change in sleep onset latency as measured by actigraphy (actigraph)

  5. Change in wake after sleep onset as measured by actigraphy

    Time frame: From baseline assessment to 1-month post intervention

    Change in wake after sleep onset as measured by actigraphy (actigraph)

  6. Change in sleep onset latency as measured by ambulatory EEG monitoring

    Time frame: From baseline assessment to 1-month post intervention

    Change in sleep onset latency as measured by ambulatory EEG sleep architecture monitoring (sleep profiler)

  7. Change in wake after sleep onset as measured by ambulatory EEG monitoring

    Time frame: From baseline assessment to 1-month post intervention

    Change in wake after sleep onset as measured by ambulatory EEG sleep architecture monitoring (sleep profiler)

  8. Change in self-reported pain as measured by the Brief Pain Inventory

    Time frame: 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.

  9. Change in behaviorally assessed pain tolerance via the Cold Pressor Test

    Time frame: 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.

  10. Change in self-reported Crohn's disease symptoms as measured by the Patient Reported Outcomes-3

    Time frame: From baseline assessment to 1-month post intervention

    The Patient Reported Outcomes-3 is a self-report questionnaire that assesses frequency of diarrhea, severity of abdominal pain, and overall well-being. Higher scores indicate more severe Crohn's disease symptoms.

  11. Change in time spent in slow wave sleep

    Time frame: 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

  12. Change in C-reactive protein

    Time frame: From baseline assessment to 1-month post intervention

    We will measure blood levels of C-reactive protein

  13. Change in fecal calprotectin

    Time frame: From baseline assessment to 1-month post intervention

    We will measure levels of fecal calprotectin via a stool sample.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Crohn's and Colitis Foundation

Registry information

Official study title

A Pilot Trial of CBT-I for Sleep, Pain, and Inflammation in Crohn's Disease

Acronym: SPIN

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2021
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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