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Crohn DiseaseSPINNCT05034159

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

A study testing Cognitive Behavioral Therapy for Insomnia in people with Crohn Disease and Insomnia, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease, Insomnia, Sleep Disturbance
What is being tested?
Cognitive Behavioral Therapy for Insomnia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
22 Oct 2021to 19 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: A Pilot Trial of 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.

Being tested
Cognitive Behavioral Therapy for Insomnia
Medical subject headings
Crohn Disease, Sleep Initiation and Maintenance Disorders, Parasomnias, Pain, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Therapy for InsomniaBehavioural

    Same as is described previously.

Study groups in NCT05034159
Study groupRoleWhat they receive
Cognitive Behavioral Therapy for InsomniaExperimentalCBT-I has a specific protocol with behavioral targets that differ significantly from standard CBT. This approach focuses on implementing sleep restriction and stimulus control interventions which are fully deployed during the first session. Five CBT-I sessions will be delivered over the course of 8 weeks. Key recommendations include: 1) reduce time in bed; 2) get up at the same time every day; 3) do not go to bed unless sleepy; 4) do not stay in bed awake for more than 15 minutes; and 5) avoid napping. Participants are also taught relaxation strategies and cognitive therapy addresses arousal and catastrophizing.
Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia
WaitlistNo interventionNo intervention for 8 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: From baseline assessment to 1-month post intervention

  2. Change in diary-based sleep onset latency

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

    Measured: From baseline assessment to 1-month post intervention

  3. Change in diary-based wake after sleep onset

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

    Measured: From baseline assessment to 1-month post intervention

Secondary outcomes (13)

  1. Change in sleep efficiency based on diary

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

    Measured: From baseline assessment to 1-month post intervention

  2. Change in sleep efficiency based on actigraphy

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

    Measured: From baseline assessment to 1-month post intervention

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

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

    Measured: From baseline assessment to 1-month post intervention

  4. Change in sleep onset latency as measured by actigraphy

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

    Measured: From baseline assessment to 1-month post intervention

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

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

    Measured: From baseline assessment to 1-month post intervention

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

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

    Measured: From baseline assessment to 1-month post intervention

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

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

    Measured: From baseline assessment to 1-month post intervention

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

    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.

    Measured: From baseline assessment to 1-month post intervention

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

    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.

    Measured: From baseline assessment to 1-month post intervention

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

    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.

    Measured: From baseline assessment to 1-month post intervention

  11. Change in time spent in slow wave sleep

    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

    Measured: From baseline assessment to 1-month post intervention

  12. Change in C-reactive protein

    We will measure blood levels of C-reactive protein

    Measured: From baseline assessment to 1-month post intervention

  13. Change in fecal calprotectin

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

    Measured: From baseline assessment to 1-month post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2021
  2. Study start22 Oct 2021
  3. Primary completion19 Apr 2023
  4. Study completion19 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Following a baseline assessment, participants are initially randomized to either CBT-I or waitlist. Those in the waitlist condition will repeat their baseline assessment after 8 weeks, then will start CBT-I.
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05034159
Sponsor's protocol ID
STUDY02001191
Acronym
SPIN
Status last verified
May 2023
First submitted
1 Sep 2021
Last updated
18 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy for Insomnia in people with Crohn Disease and Insomnia, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in insomnia symptoms as measured by the Insomnia Severity Index (time frame: From baseline assessment to 1-month post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05034159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.

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