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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
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.
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Follow Up (week 15)
Actigraph Compliance-Tracking Study
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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.
Time frame: 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.
Time frame: Follow up (Week 15)
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?").
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Tracking Study: Baseline (Week 1), Treatment Study: Follow up (week 15)