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Inflammatory Bowel DiseasesFITTNCT04132024

Feasibility of Insomnia Tracking and Treatment in IBD

A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) in people with Inflammatory Bowel Diseases and Insomnia, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Inflammatory Bowel Diseases, Insomnia
What is being tested?
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
7 Oct 2019to 15 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Documented IBD
  • Mild to moderate Crohn's Disease or Ulcerative Colitis as measured by the Physicians Global Assessment
  • 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
Show all 14Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766-1000

Other trials in United States

About this study

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

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).

Being tested
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Keywords
Cognitive Behavioral Therapy for Insomnia (CBT-I), Insomnia, Sleep, Crohn's Disease, Ulcerative Colitis
Medical subject headings
Inflammatory Bowel Diseases, Sleep Initiation and Maintenance Disorders, Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Therapy for Insomnia (CBT-I)Behavioural

    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.

Study groups in NCT04132024
Study groupRoleWhat they receive
Cognitive Behavioral Therapy for InsomniaExperimentalCBT-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.
Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Tracking Study: Baseline (average of weeks 1 & 2), Treatment Study: Follow Up (change from baseline to week 15)

  2. Recruitment Rate

    Number of participants screened into the study per month will help measure feasibility.

    Measured: Tracking Study: Baseline (Week 1)

  3. 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.

    Measured: Baseline (average of weeks 1 & 2)

  4. 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.

    Measured: Follow Up (week 15)

  5. 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.

    Measured: Baseline (Week 1)

  6. 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.

    Measured: Follow Up (week 15)

  7. 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.

    Measured: Baseline (Week 1)

  8. 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.

    Measured: Follow up (Week 15)

Secondary outcomes (20)
  1. 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?").

    Measured: Treatment Study: Visit 1 (Week 3) and Follow up (Week 15)

  2. 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

    Measured: Tracking Study: Baseline (Week 1) and Follow up (Week 15)

  3. 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.

    Measured: Tracking Study: Baseline (Week 1)

  4. 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.

    Measured: Tracking Study: Baseline (Week 1), Treatment Study: Visit 5 (Week 11), Follow up (Week 15)

  5. 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.

    Measured: Tracking Study: Baseline (Week1), Treatment Study: Visit 1 (Week 3), Visit 5 (Week 11) Follow up (Week 15)

  6. 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".

    Measured: Tracking Study: Baseline (Week 1)

  7. 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.

    Measured: Tracking Study: Baseline (Week 1), Treatment Study: Follow up (Week 15)

  8. 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.

    Measured: Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15)

  9. 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.

    Measured: Tracking Study: Baseline (Week 1), Treatment Study: Visit 5 (Week 11), Follow up (week 15)

  10. 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.

    Measured: Tracking Study: Baseline (Week 1)

  11. 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.

    Measured: Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Visit 5 (week 11), Follow up(week 15)

  12. 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).

    Measured: Tracking Study: Baseline (Week 1), Follow up (Week 15)

  13. 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.

    Measured: Tracking: Baseline (Week 1), Follow up (week 15)

  14. 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.

    Measured: Tracking Study: Baseline (Week 1), Treatment: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15)

  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.

    Measured: Tracking Study: Baseline (Week 1), Treatment: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15)

  16. 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.

    Measured: Tracking Study: Baseline (Week 1), Treatment: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15)

  17. 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.

    Measured: Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Follow up (week 15)

  18. 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.

    Measured: Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Follow up (week 15)

  19. 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

    Measured: Tracking Study: Baseline (Week 1), Treatment Study: Follow up (week 15)

  20. 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.

    Measured: Tracking Study: Baseline (Week 1), Treatment Study: Follow up (week 15)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2019
  2. Study start7 Oct 2019
  3. Primary completion15 Apr 2021
  4. Study completion15 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04132024
Sponsor's protocol ID
D19155
Acronym
FITT
Status last verified
May 2021
First submitted
15 Oct 2019
Last updated
11 May 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Salwen-Deremer JK, Reid MJ, Westvold SJ, Siegel CA, Smith MT. People with IBD evidence more microarousals during sleep architecture assessments. BMJ Open Gastroenterol. 2023 Dec 28;10(1):e001249. doi: 10.1136/bmjgast-2023-001249.

    PubMed 38154825
  • 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.

    PubMed 34969664

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) in people with Inflammatory Bowel Diseases and Insomnia, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in sleep continuity (time frame: Tracking Study: Baseline (average of weeks 1 & 2), Treatment Study: Follow Up (change from baseline to week 15)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04132024, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.

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