Feasibility of Insomnia Tracking and Treatment in IBD (FITT)

Dartmouth Health

Status: Completed

Conditions: Insomnia; Inflammatory Bowel Diseases

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Study type: Interventional

Funder types: Other

Identifiers

NCT04132024

D19155

Details and patient eligibility

About

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).

Enrollment: 39 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Cognitive Behavioral Therapy for Insomnia

Experimental group

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.

Treatment:

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