Feasibility of Insomnia Tracking and Treatment in IBD

Feasibility of Insomnia Tracking and Treatment in IBD (FITT)

Sponsors

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Source Dartmouth-Hitchcock Medical Center
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).

Overall Status Completed
Start Date 2019-10-07
Completion Date 2021-04-15
Primary Completion Date 2021-04-15
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in sleep continuity Tracking Study: Baseline (average of weeks 1 & 2), Treatment Study: Follow Up (change from baseline to week 15)
Recruitment Rate Tracking Study: Baseline (Week 1)
Completion of Study Measures-Tracking Study Baseline (average of weeks 1 & 2)
Completion of Study Measures- Treatment Study Follow Up (week 15)
ActiGraph Use-Tracking Study Baseline (Week 1)
ActiGraph Use-Treatment Study Follow Up (week 15)
Actigraph Compliance-Tracking Study Baseline (Week 1)
Actigraph Compliance-Treatment Study Follow up (Week 15)
Secondary Outcome
Measure Time Frame
Treatment liking Treatment Study: Visit 1 (Week 3) and Follow up (Week 15)
Change in Sleepiness Tracking Study: Baseline (Week 1) and Follow up (Week 15)
Restless Leg Syndrome Tracking Study: Baseline (Week 1)
Change in beliefs and attitudes about sleep Tracking Study: Baseline (Week 1), Treatment Study: Visit 5 (Week 11), Follow up (Week 15)
Change in Insomnia Severity Tracking Study: Baseline (Week1), Treatment Study: Visit 1 (Week 3), Visit 5 (Week 11) Follow up (Week 15)
Circadian Rhythms Tracking Study: Baseline (Week 1)
Change in general fatigue Tracking Study: Baseline (Week 1), Treatment Study: Follow up (Week 15)
Change in general sleep quality 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. Tracking Study: Baseline (Week 1), Treatment Study: Visit 5 (Week 11), Follow up (week 15)
Sleep Apnea Tracking Study: Baseline (Week 1)
Change in pain Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Visit 5 (week 11), Follow up(week 15)
Change in pain related disability Tracking Study: Baseline (Week 1), Follow up (Week 15)
Change in beliefs about pain Tracking: Baseline (Week 1), Follow up (week 15)
Change in individual's beliefs about IBD symptoms Tracking Study: Baseline (Week 1), Treatment: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15)
Change in IBD severity Tracking Study: Baseline (Week 1), Treatment: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15)
Change in IBD symptom severity Tracking Study: Baseline (Week 1), Treatment: Visit 1 (week 3), Visit 5 (week 11), Follow up (week 15)
Change in severity of anxiety symptoms Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Follow up (week 15)
Change in severity of depression symptoms Tracking Study: Baseline (Week 1), Treatment Study: Visit 1 (week 3), Follow up (week 15)
Change in stress Tracking Study: Baseline (Week 1), Treatment Study: Follow up (week 15)
Change in overall health and quality of life Tracking Study: Baseline (Week 1), Treatment Study: Follow up (week 15)
Enrollment 39
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Cognitive Behavioral Therapy for Insomnia (CBT-I)

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.

Arm Group Label: Cognitive Behavioral Therapy for Insomnia

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

Gender:

All

Minimum Age:

N/A

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: Jessica K Salwen-Deremer, PhD

Phone: (603) 650-5261

Email: [email protected]

Location
Facility: Dartmouth-Hitchcock Medical Center
Location Countries

United States

Verification Date

2021-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Dartmouth-Hitchcock Medical Center

Investigator Full Name: Jessica.K.Salwen-Deremer

Investigator Title: Assistant Professor, Departments of Psychiatry & Medicine, Section of Gastroenterology & Hepatology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Cognitive Behavioral Therapy for Insomnia

Type: Experimental

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.

Acronym FITT
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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