RISE: A Remote Study of Insomnia Treatment in Crohn's Disease
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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, patients 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 investigators want to understand if they can treat sleep problems in people with Crohn's disease, and what else might improve if sleep gets better. If this study is successful, it will help the investigators understand more about 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Behavioral Treatment
|
Behavioral: Behavioral Treatment
In the first intervention visit, participants are taught about the predisposing, precipitating, and perpetuating factors. We also discuss factors that drive insomnia, including conditioned arousal, circadian rhythms, and sleep drive). Sleep restriction and stimulus control, behavioral interventions, are deployed in the first session based on data from the sleep diaries. Diaries are reviewed each visit thereafter, with sleep prescriptions changing over the course of the intervention based on diary data. 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 sleep hygiene, relaxation, cognitive therapy, and relapse prevention. Behavioral strategies produce immediate changes to insomnia, while cognitive therapy is important for maintenance of gains.
Other Names:
|
| Placebo Comparator: Sleep Education Treatment
|
Behavioral: Sleep Education Treatment
The sleep education control is designed to engage participants without recommending any behavioral strategies or teaching any coping skills. During the first visit, participants are provided with education about sleep and CD. They will keep a diary on Crohn's symptoms and rate their sleep quality each night; however they will not track sleep patterns and specific variables the way that CBT-I participants do. The other sessions include education on and discussion about a) sleep hygiene and pain, b) sleep hygiene and stress, c) sleep and mental health, and d) a general review of treatment content and discussion of sleep on overall health.
|
Outcome Measures
Primary Outcome Measures
- Feasibility of the intervention as measured by attrition rate over time [Baseline, 8 weeks, 21 weeks, and 34 weeks]
Attrition rate will be based on the percentage of participants who have dropped out of the trial at different time points.
- Feasibility of the intervention as measured by recruitment rate over time [From study initiation until we are no longer actively recruiting (approximately 24 months)]
Recruitment rate will be based on the number of participants who are recruited into the trial per month.
- Feasibility of the intervention as measured by assessment completion at multiple time points [Baseline, 8 weeks, 21 weeks, and 34 weeks]
Assessment completion rate will be based on the percentage of participants who complete all the required questionnaires and tasks at each time point.
- Feasibility of the intervention as measured by qualitative interviews [8 weeks and 34 weeks]
Feasibility will be based on interview-derived themes related to barriers and facilitators to study engagement. Data will be collected at two time points to ensure completeness of themes.
- Acceptability of the intervention as measured by visit completion [8 weeks]
Visit completion will be based the number of visits (out of 5) completed by each participant.
- Treatment acceptability questionnaire score [1 week]
The Treatment Acceptability Questionnaire is a 4-item self-report questionnaire designed to assess the overall acceptability of an intervention. Scores range from 1 to 4 and higher scores are indicative of greater acceptability.
- Acceptability of the intervention as measured by qualitative interviews [8 weeks]
Acceptability will be based on interview-derived themes related to aspects of the intervention that participants found helpful and unhelpful.
Secondary Outcome Measures
- Change in insomnia symptoms as measured by the Insomnia Severity Index [Baseline, 8 weeks, 21 weeks, and 34 weeks]
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.
- Change in diary-based sleep onset latency [Baseline, 8 weeks, 21 weeks, and 34 weeks]
A weekly average of self-reported time it takes to fall asleep each night, derived from a self-reported sleep diary
- Change in diary-based wake after sleep onset [Baseline, 8 weeks, 21 weeks, and 34 weeks]
A weekly average of self-reported time spent awake in the middle of each night, derived from a self-reported sleep diary
- Change in Crohn's disease symptoms as measured by the Patient Reported Outcomes 3 [Baseline, 8 weeks, 21 weeks, and 34 weeks]
The Patient Reported Outcomes 3 (PRO-3) is a self-report questionnaire designed to measure the severity of Crohn's disease symptoms in the past week. The PRO-3 is made up of 3 items (stool frequency, pain, and well-being) and higher scores are indicative of more severe symptoms. Scores are interpreted as follows: <13=quiescent or inactive disease; 13-21=mildly active disease; 22-52=moderately active disease; 53 and up=severely active disease.
Other Outcome Measures
- Change in C-reactive protein [Baseline, 8 weeks, and 21 weeks]
We will measure blood levels of C-reactive protein
- Change in fecal calprotectin [Baseline, 8 weeks, and 21 weeks]
We will measure levels of fecal calprotectin via a stool sample.
- Change in sleep architecture [Baseline, 8 weeks, and 21 weeks]
We will measure changes in percent time spent in light sleep, deep sleep, and rapid eye movement (REM) sleep using the Oura ring.
- Change in behaviorally assessed pain tolerance via the Cold Pressor Test [Baseline, 8 weeks, and 21 weeks]
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 3 minutes.
- Change in diary-based sleep efficiency [Baseline, 8 weeks, 21 weeks, and 34 weeks]
Change in sleep efficiency (total sleep time / time in bed), derived from a self-reported sleep diary.
- Change in objective sleep onset latency [Baseline, 8 weeks, and 21 weeks]
Change in the time it takes to fall asleep each night, derived from the Oura ring.
- Change in objective wake after sleep onset [Baseline, 8 weeks, and 21 weeks]
Change in the time spent awake in the middle of the night, derived from the Oura ring.
- Change in objective sleep efficiency [Baseline, 8 weeks, and 21 weeks]
Change in sleep efficiency (total sleep time / time in bed), derived from the Oura ring.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Mild to moderate CD based on PRO-3 & objective data
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Insomnia Severity Index score ≥ 8 and SOL or WASO ≥ 30 minutes
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Stability of sleep & CD meds for ≥ 3 months
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Access to internet or cell phone service sufficient for telehealth
Exclusion Criteria:
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PHQ-9 depression score ≥ 15
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GAD-7 anxiety score ≥ 15
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Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder)
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Current alcohol or substance abuse
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Current opioid use for pain control
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Current smoker (tobacco, nicotine)
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Current systemic corticosteroid use
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Current pregnancy or nursing
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Ileostomy or colostomy
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Diagnosis of seizure disorder
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Diagnosis of sleep apnea or positive WatchPAT screen
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Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screen
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Night shift, rotating shift work, or frequent travel outside of time zone
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
Sponsors and Collaborators
- Dartmouth-Hitchcock Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY02001855