Feasibility of Insomnia Tracking and Treatment in IBD

NCT04132024 | Completed

• 1 other identifier: D19155
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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).

Conditions

Inflammatory Bowel Diseases; Insomnia

Keywords

Cognitive Behavioral Therapy for Insomnia (CBT-I); Insomnia; Sleep; Crohn's Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (8)

• 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.

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

• Recruitment Rate

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

  Tracking Study: Baseline (Week 1)

• 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.

  Baseline (average of weeks 1 & 2)

• 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.

  Follow Up (week 15)

• 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.

  Baseline (Week 1)

• 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.

  Follow Up (week 15)

• 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.

  Baseline (Week 1)

• 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.

  Follow up (Week 15)

Secondary Outcomes (20)

• 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)

Study Arms (1)

Cognitive Behavioral Therapy for Insomnia

EXPERIMENTAL

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.

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

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I) BEHAVIORAL

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.

Cognitive Behavioral Therapy for Insomnia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766-1000, United States

Location

Related Publications (2)

• 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.

  PMID: 38154825 DERIVED

• 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.

  PMID: 34969664 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Sleep Initiation and Maintenance Disorders; Crohn Disease; Colitis, Ulcerative

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Departments of Psychiatry & Medicine, Section of Gastroenterology & Hepatology

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 18, 2019
• Study Start: October 7, 2019
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

US (1)