Feasibility of Insomnia Tracking and Treatment in IBD

Study Overview
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Brief Summary
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This study is a longitudinal clinical trial designed to characterize sleep patterns in individuals with Inflammatory Bowel Disease (IBD) as well as to assess the feasibility of sleep intervention (Cognitive Behavioral Therapy for Insomnia (CBT-I)) in individuals with both insomnia and Inflammatory Bowel Disease (IBD).

Official Title
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Feasibility of Insomnia Tracking and Treatment in IBD (FITT)

Conditions
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Inflammatory Bowel Diseases, Insomnia

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (IBD Participants): Documented IBD Mild to moderate Crohn's Disease or Ulcerative Colitis as measured by the Physicians Global Assessment Inclusion Criteria (Healthy Participants) No personal history of IBD No personal history of Irritable Bowel Syndrome (IBS) or Celiac Disease No current gastrointestinal symptoms or concerns No family history of IBD or Celiac Disease Exclusion Criteria (both IBD participants and healthy participants) PHQ-9 depression score > 15 GAD-7 anxiety score > 15 Current alcohol or substance abuse Current narcotic use Unstable major psychiatric condition Current sleep apnea or restless leg syndrome Other problems that would interfere with study participation at investigator discretion
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy for Insomnia<br>CBT-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. We will deliver 5 CBT-I sessions 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. | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)<br>* CBT-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. 5 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep continuity | Sleep continuity will be measured by sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE), based on ActiGraph data and daily diary data. Sleep parameters measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer. Measured in minutes of sleep per night. Higher number indicating longer sleep duration. | Tracking Study: Baseline (average of weeks 1 & 2), Treatment Study: Follow Up (change from baseline to week 15) | 
| Recruitment Rate | Number of participants screened into the study per month will help measure feasibility. | Tracking Study: Baseline (Week 1) | 
| Completion of Study Measures-Tracking Study | The average percentage of study measures (daily diaries and CBT-I sessions) that are completed across participants will help determine feasibility. | Baseline (average of weeks 1 & 2) | 
| Completion of Study Measures- Treatment Study | The average percentage of study measures (daily diaries and CBT-I sessions) that are completed across participants will help determine feasibility. | Follow Up (week 15) | 
| ActiGraph Use-Tracking Study | The average percentage of days spent wearing the medical-grade Fitbit-like-device that collects sleep and physical activity data to help assess feasibility. | Baseline (Week 1) | 
| ActiGraph Use-Treatment Study | The average percentage of days spent wearing the medical-grade Fitbit-like-device that collects sleep and physical activity data to help assess feasibility. | Follow Up (week 15) | 
| Actigraph Compliance-Tracking Study | The average percentage of hours of wear per day of the medical-grade Fitbit-like-device that collects sleep and physical activity data to help assess feasibility. | Baseline (Week 1) | 
| Actigraph Compliance-Treatment Study | The average percentage of hours of wear per day of the medical-grade Fitbit-like-device that collects sleep and physical activity data to help assess feasibility. | Follow up (Week 15) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment liking | Treatment Acceptability Questionnaire will measure acceptability with patient-reported treatment satisfaction, and open-ended questions about satisfaction with both CBT-I and telemedicine (e.g., What did you think about treating sleep as part of your IBD care?; How did you feel about getting treatment without being face-to-face?; What could we do to improve your treatment experience?). | Treatment Study: Visit 1 (Week 3) and Follow up (Week 15) | 
| Change in Sleepiness | The Epworth Sleepiness Scale will be used to assess general daytime sleepiness. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness | Tracking Study: Baseline (Week 1) and Follow up (Week 15) | 
| Restless Leg Syndrome | The Cambridge Hopkins Restless Leg Syndrome questionnaire will be used to assess the likelihood of Restless Leg Syndrome (RLS). Participants are categorized into definite not RLS, not RLS, probable RLS, and definite RLS based on item response patterns. A total score is not calculated. | Tracking Study: Baseline (Week 1) | 
| Change in beliefs and attitudes about sleep | The Dysfunctional Beliefs & Attitudes About Sleep questionnaire will be used to assess beliefs about sleep. Except for item 23 (on the 30-item version) for which the score is reversed, a higher score indicates more dysfunctional beliefs and attitudes about sleep. The total score is based on the average score of all items. Subscale scores can be computed by adding the sum of scores for the items and dividing by the number of items making up each subscale. | Tracking Study: Baseline (Week 1), Treatment Study: Visit 5 (Week 11), Follow up (Week 15) | 
| Change in Insomnia Severity | The Insomnia Severity Index will be used to assess insomnia symptoms. The total score ranges from 0 to 63, with higher scores indicating more severe anxiety symptoms. | Tracking Study: Baseline (Week1), Treatment Study: Visit 1 (Week 3), Visit 5 (Week 11) Follow up (Week 15) | 
| Circadian Rhythms | The Morningness-Eveningness Questionnaire (MEQ) will be used to assess whether the patient's circadian rhythm produces peak alertness in the morning or the evening. Multiple choice, 4-5 point scale. The sum gives a score ranging from 16 to 86; scores of 41 and below indicate evening types, scores of 59 and above indicate morning types, scores between 42-58 indicate intermediate types. | Tracking Study: Baseline (Week 1) | 
| Change in general fatigue | The Multidimensional Fatigue Inventory will be used to assess general fatigue. Items are scored 1-5, with 10 positively phrased items reverse scored (this concerns following items: 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). For each of the 5 scales (general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue) a total score is calculated by summation of the scores of the individual items. Scores can range from the minimum of 4 to the maximum of 20. | Tracking Study: Baseline (Week 1), Treatment Study: Follow up (Week 15) | 
| Change in general sleep quality | The Pittsburg Sleep Quality Index will be used to assess general sleep quality and disturbances. A total score of 5 or more is indicative of poor sleep quality. Possible score range is 0-21. | Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15) | 
| Change in behaviors that can interfere with sleep. | The Sleep Hygiene Index will be used to assess the presence of behaviors that can interfere with sleep. A 13-item self-report measure designed to assess the practice of sleep hygiene behaviors. Each item is rated on a five-point scale ranging from 0 (never) to 4 (always). Total scores range from 0 to 52, with a higher score representing poorer sleep hygiene. | Tracking Study: Baseline (Week 1), Treatment Study: Visit 5 (Week 11), Follow up (week 15) | 
| Sleep Apnea | The STOP-BANG Questionnaire will be used to assess the patient's risk for sleep apnea. Scores range from 0-8. The higher the score indicates an increase in the probability of sleep apnea. | Tracking Study: Baseline (Week 1) | 
| Change in pain | 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. | Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Visit 5 (week 11), Follow up(week 15) | 
| Change in pain related disability | The Graded Chronic Pain Scale will be used to assess the pain-related disability. Responses are translated into a chronic pain grade, from 0 (no pain) to 4 (severe interference). | Tracking Study: Baseline (Week 1), Follow up (Week 15) | 
| Change in beliefs about pain | The Pain Catastrophizing Scale will be used to assess beliefs about pain. Scores range from 0-52, with higher scores indicating greater catastrophizing. | Tracking: Baseline (Week 1), Follow up (week 15) | 
| Change in individual's beliefs about IBD symptoms | The Overall Disease Severity Index will be used to assess an individual's beliefs about IBD symptoms. This is a single item measure, with higher scores indicating greater IBD severity. | Tracking Study: Baseline (Week 1), Treatment: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15) | 
| Change in IBD severity | The Physicians Global Assessment will be used to complete a physician rated IBD severity assessment; physicians categorize severity of IBD based on symptom presentation. | Tracking Study: Baseline (Week 1), Treatment: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15) | 
| Change in IBD symptom severity | Patient Reported Outcome Measures (PRO-3) will be used to assess the severity of IBD symptoms, where greater scores indicate more severe IBD symptoms. | Tracking Study: Baseline (Week 1), Treatment: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15) | 
| Change in severity of anxiety symptoms | The Generalized Anxiety Disorder-7 will be used to assess overall severity of anxiety symptoms The GAD7 scores range from 5-21, with 5-9 indicating mild, 10-14 moderate, and greater than 15 severe anxiety. | Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Follow up (week 15) | 
| Change in severity of depression symptoms | The Patient Health Questionnaire-9 will be used to assess overall severity of depression symptoms. The PHQ9 scores range from 0-27, with lower numbers indicating minimal to no depression and higher numbers indicating severe depression. | Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Follow up (week 15) | 
| Change in stress | The Perceived Stress Scale will be used to assess general stress. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress | Tracking Study: Baseline (Week 1), Treatment Study: Follow up (week 15) | 
| Change in overall health and quality of life | The Short Form-36 will be used to assess overall health and impact on quality of life. Consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. | Tracking Study: Baseline (Week 1), Treatment Study: Follow up (week 15) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavioral Therapy for Insomnia (CBT-I), Insomnia, Sleep, Crohn's Disease, Ulcerative Colitis