Clinical trial NCT04132024: Feasibility of Insomnia Tracking and Treatment in IBD
Official title: Feasibility of Insomnia Tracking and Treatment in IBD (FITT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Insomnia
Keywords: Cognitive Behavioral Therapy for Insomnia (CBT-I)
Insomnia
Sleep
Crohn's Disease
Ulcerative Colitis
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change in sleep continuity
timeFrame: Tracking Study: Baseline (average of weeks 1 & 2), Treatment Study: Follow Up (change from baseline to week 15)
measure: Recruitment Rate
timeFrame: Tracking Study: Baseline (Week 1)
measure: Completion of Study Measures-Tracking Study
timeFrame: Baseline (average of weeks 1 & 2)
measure: Completion of Study Measures- Treatment Study
timeFrame: Follow Up (week 15)
measure: ActiGraph Use-Tracking Study
timeFrame: Baseline (Week 1)
measure: ActiGraph Use-Treatment Study
timeFrame: Follow Up (week 15)
measure: Actigraph Compliance-Tracking Study
timeFrame: Baseline (Week 1)
measure: Actigraph Compliance-Treatment Study
timeFrame: Follow up (Week 15)
Secondary outcomes:
measure: Treatment liking
timeFrame: Treatment Study: Visit 1 (Week 3) and Follow up (Week 15)
measure: Change in Sleepiness
timeFrame: Tracking Study: Baseline (Week 1) and Follow up (Week 15)
measure: Restless Leg Syndrome
timeFrame: Tracking Study: Baseline (Week 1)
measure: Change in beliefs and attitudes about sleep
timeFrame: Tracking Study: Baseline (Week 1), Treatment Study: Visit 5 (Week 11), Follow up (Week 15)
measure: Change in Insomnia Severity
timeFrame: Tracking Study: Baseline (Week1), Treatment Study: Visit 1 (Week 3), Visit 5 (Week 11) Follow up (Week 15)
measure: Circadian Rhythms
timeFrame: Tracking Study: Baseline (Week 1)
measure: Change in general fatigue
timeFrame: Tracking Study: Baseline (Week 1), Treatment Study: Follow up (Week 15)
measure: Change in general sleep quality
timeFrame: Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15)
measure: Change in behaviors that can interfere with sleep.
timeFrame: Tracking Study: Baseline (Week 1), Treatment Study: Visit 5 (Week 11), Follow up (week 15)
measure: Sleep Apnea
timeFrame: Tracking Study: Baseline (Week 1)
measure: Change in pain
timeFrame: Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Visit 5 (week 11), Follow up(week 15)
measure: Change in pain related disability
timeFrame: Tracking Study: Baseline (Week 1), Follow up (Week 15)
measure: Change in beliefs about pain
timeFrame: Tracking: Baseline (Week 1), Follow up (week 15)
measure: Change in individual's beliefs about IBD symptoms
timeFrame: Tracking Study: Baseline (Week 1), Treatment: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15)
measure: Change in IBD severity
timeFrame: Tracking Study: Baseline (Week 1), Treatment: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15)
measure: Change in IBD symptom severity
timeFrame: Tracking Study: Baseline (Week 1), Treatment: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15)
measure: Change in severity of anxiety symptoms
timeFrame: Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Follow up (week 15)
measure: Change in severity of depression symptoms
timeFrame: Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Follow up (week 15)
measure: Change in stress
timeFrame: Tracking Study: Baseline (Week 1), Treatment Study: Follow up (week 15)
measure: Change in overall health and quality of life
timeFrame: Tracking Study: Baseline (Week 1), Treatment Study: Follow up (week 15)
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
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.