RISE: A Remote Study of Insomnia Treatment in Crohn's Disease

N/AActive Not RecruitingNCT05956158

Dartmouth-Hitchcock Medical Center83 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Insomnia Crohn Disease

Interventions

Behavioral TreatmentBEHAVIORAL

This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia.

Sleep Education TreatmentBEHAVIORAL

This treatment is designed to help participants understand the relationships among sleep, pain, and Crohn's disease and to make changes to insomnia-related behaviors.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Mild to moderate CD based on PRO-3 \& 50% with objective evidence of active disease * Insomnia Severity Index score ≥ 8 and SOL or WASO ≥ 30 minutes * Stability of sleep \& CD meds for ≥ 3 months * Access to internet or cell phone service sufficient for telehealth Exclusion Criteria: * PHQ-9 depression score ≥ 15 * GAD-7 anxiety score ≥ 15 * Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder) * Current alcohol or substance abuse * Current opioid 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 WatchPAT screen * Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screen * Night shift, rotating shift work, or frequent travel outside of time zone

Locations (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Outcomes

Primary Outcomes

Feasibility of the intervention as measured by attrition rate over time

Attrition rate will be based on the percentage of participants who have dropped out of the trial at different time points.

Time frame: Baseline, 8 weeks, 21 weeks, and 34 weeks

Feasibility of the intervention as measured by recruitment rate over time

Recruitment rate will be based on the number of participants who are recruited into the trial per month.

Time frame: From study initiation until we are no longer actively recruiting (approximately 24 months)

Feasibility of the intervention as measured by assessment completion at multiple time points

Assessment completion rate will be based on the percentage of participants who complete all the required questionnaires and tasks at each time point.

Time frame: Baseline, 8 weeks, 21 weeks, and 34 weeks

Feasibility of the intervention as measured by qualitative interviews

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.

Time frame: 8 weeks and 34 weeks

Acceptability of the intervention as measured by visit completion

Visit completion will be based the number of visits (out of 5) completed by each participant.

Time frame: 8 weeks

Treatment acceptability questionnaire score

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.

Time frame: 1 week

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

Time frame: Baseline, 8 weeks, 21 weeks, and 34 weeks

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

Time frame: Baseline, 8 weeks, 21 weeks, and 34 weeks

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

Time frame: Baseline, 8 weeks, 21 weeks, and 34 weeks

Change in Crohn's disease symptoms as measured by the Patient Reported Outcomes 3

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.

Time frame: Baseline, 8 weeks, 21 weeks, and 34 weeks