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

NCT05956158 | Recruiting DMC

• 1 other identifier: STUDY02001855
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Crohn Disease

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  1 week

• Acceptability of the intervention as measured by qualitative interviews

  Acceptability will be based on interview-derived themes related to aspects of the intervention that participants found helpful and unhelpful.

  8 weeks

Secondary Outcomes (4)

• Change in insomnia symptoms as measured by the Insomnia Severity Index

  Baseline, 8 weeks, 21 weeks, and 34 weeks

• Change in diary-based sleep onset latency

  Baseline, 8 weeks, 21 weeks, and 34 weeks

• Change in diary-based wake after sleep onset

  Baseline, 8 weeks, 21 weeks, and 34 weeks

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

  Baseline, 8 weeks, 21 weeks, and 34 weeks

Other Outcomes (8)

• Change in C-reactive protein

  Baseline, 8 weeks, and 21 weeks

• Change in fecal calprotectin

  Baseline, 8 weeks, and 21 weeks

• Change in sleep architecture

  Baseline, 8 weeks, and 21 weeks

Study Arms (2)

Behavioral Treatment

EXPERIMENTAL

Behavioral: Behavioral Treatment

Sleep Education Treatment

PLACEBO COMPARATOR

Behavioral: Sleep Education Treatment

Interventions

Behavioral Treatment BEHAVIORAL

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

Also known as: Cognitive Behavioral Therapy for Insomnia, CBT-I

Behavioral Treatment

Sleep Education Treatment BEHAVIORAL

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.

Sleep Education Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Crohn Disease

Interventions

Behavior Therapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry & Medicine

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 21, 2023
• Study Start: November 28, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

US (1)