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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05956158




Registration number
NCT05956158
Ethics application status
Date submitted
22/06/2023
Date registered
21/07/2023
Date last updated
1/10/2024

Titles & IDs
Public title
RISE: A Remote Study of Insomnia Treatment in Crohn's Disease
Scientific title
RISE: A Remote Study of Insomnia Treatment in Crohn's Disease
Secondary ID [1] 0 0
STUDY02001855
Universal Trial Number (UTN)
Trial acronym
RISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 0 0
Crohn Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Behavioral Treatment
BEHAVIORAL - Sleep Education Treatment

Experimental: Behavioral Treatment -

Placebo comparator: Sleep Education Treatment -


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

BEHAVIORAL: Sleep Education Treatment
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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of the intervention as measured by attrition rate over time
Timepoint [1] 0 0
Baseline, 8 weeks, 21 weeks, and 34 weeks
Primary outcome [2] 0 0
Feasibility of the intervention as measured by recruitment rate over time
Timepoint [2] 0 0
From study initiation until we are no longer actively recruiting (approximately 24 months)
Primary outcome [3] 0 0
Feasibility of the intervention as measured by assessment completion at multiple time points
Timepoint [3] 0 0
Baseline, 8 weeks, 21 weeks, and 34 weeks
Primary outcome [4] 0 0
Feasibility of the intervention as measured by qualitative interviews
Timepoint [4] 0 0
8 weeks and 34 weeks
Primary outcome [5] 0 0
Acceptability of the intervention as measured by visit completion
Timepoint [5] 0 0
8 weeks
Primary outcome [6] 0 0
Treatment acceptability questionnaire score
Timepoint [6] 0 0
1 week
Primary outcome [7] 0 0
Acceptability of the intervention as measured by qualitative interviews
Timepoint [7] 0 0
8 weeks
Secondary outcome [1] 0 0
Change in insomnia symptoms as measured by the Insomnia Severity Index
Timepoint [1] 0 0
Baseline, 8 weeks, 21 weeks, and 34 weeks
Secondary outcome [2] 0 0
Change in diary-based sleep onset latency
Timepoint [2] 0 0
Baseline, 8 weeks, 21 weeks, and 34 weeks
Secondary outcome [3] 0 0
Change in diary-based wake after sleep onset
Timepoint [3] 0 0
Baseline, 8 weeks, 21 weeks, and 34 weeks
Secondary outcome [4] 0 0
Change in Crohn's disease symptoms as measured by the Patient Reported Outcomes 3
Timepoint [4] 0 0
Baseline, 8 weeks, 21 weeks, and 34 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2026
Actual
Sample size
Target
83
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Hampshire

Funding & Sponsors
Primary sponsor type
Other
Name
Dartmouth-Hitchcock Medical Center
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05956158
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05956158