Back to resultsFeasibility of Insomnia Tracking and Treatment in IBD (FITT)
Primary Purpose
Inflammatory Bowel Diseases, Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Cognitive Behavioral Therapy for Insomnia (CBT-I), Insomnia, Sleep, Crohn's Disease, Ulcerative Colitis
Eligibility Criteria
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
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive Behavioral Therapy for Insomnia
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Recruitment Rate
Number of participants screened into the study per month will help measure feasibility.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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?").
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
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.
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.
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.
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".
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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
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.
Full Information
NCT ID
NCT04132024
First Posted
October 15, 2019
Last Updated
May 10, 2021
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04132024
Brief Title
Feasibility of Insomnia Tracking and Treatment in IBD
Acronym
FITT
Official Title
Feasibility of Insomnia Tracking and Treatment in IBD (FITT)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 7, 2019 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
April 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Insomnia
Keywords
Cognitive Behavioral Therapy for Insomnia (CBT-I), Insomnia, Sleep, Crohn's Disease, Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral Therapy for Insomnia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in sleep continuity
Description
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)
Title
Recruitment Rate
Description
Number of participants screened into the study per month will help measure feasibility.
Time Frame
Tracking Study: Baseline (Week 1)
Title
Completion of Study Measures-Tracking Study
Description
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)
Title
Completion of Study Measures- Treatment Study
Description
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)
Title
ActiGraph Use-Tracking Study
Description
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)
Title
ActiGraph Use-Treatment Study
Description
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)
Title
Actigraph Compliance-Tracking Study
Description
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)
Title
Actigraph Compliance-Treatment Study
Description
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)
Secondary Outcome Measure Information:
Title
Treatment liking
Description
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)
Title
Change in Sleepiness
Description
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)
Title
Restless Leg Syndrome
Description
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)
Title
Change in beliefs and attitudes about sleep
Description
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)
Title
Change in Insomnia Severity
Description
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)
Title
Circadian Rhythms
Description
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)
Title
Change in general fatigue
Description
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)
Title
Change in general sleep quality
Description
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)
Title
Change in behaviors that can interfere with sleep.
Description
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)
Title
Sleep Apnea
Description
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)
Title
Change in pain
Description
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)
Title
Change in pain related disability
Description
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)
Title
Change in beliefs about pain
Description
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)
Title
Change in individual's beliefs about IBD symptoms
Description
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)
Title
Change in IBD severity
Description
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)
Title
Change in IBD symptom severity
Description
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)
Title
Change in severity of anxiety symptoms
Description
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)
Title
Change in severity of depression symptoms
Description
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)
Title
Change in stress
Description
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)
Title
Change in overall health and quality of life
Description
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)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766-1000
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34969664
Citation
Salwen-Deremer JK, Smith MT, Aschbrenner KA, Haskell HG, Speed BC, Siegel CA. A pilot feasibility trial of cognitive-behavioural therapy for insomnia in people with inflammatory bowel disease. BMJ Open Gastroenterol. 2021 Dec;8(1):e000805. doi: 10.1136/bmjgast-2021-000805.
Results Reference
derived
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Feasibility of Insomnia Tracking and Treatment in IBD
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