Cognitive Behavioral Therapy for Insomnia (CBTI) in GERD Patients With Insomnia

NCT03904472 | Completed

• 1 other identifier: HUM00157452
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study will enroll patients with persistent reflux symptoms despite proton-pump inhibitor therapy and chronic insomnia. Participants that are eligible for the study and agree to participate will receive cognitive behavioral therapy for insomnia (CBTI) delivered by a web-based approach. The goal of the treatment is to improve the participants insomnia and reflux symptoms. In addition to the cognitive behavioral therapy, participants will be asked to keep a daily diary and periodically complete questionnaires to assess their symptoms.

Conditions

Gastroesophageal Reflux Disease

Keywords

cognitive behavioral therapy; GERD

Outcome Measures

Primary Outcomes (2)

• Reflux Symptom Questionnaire-7-day recall (RESQ-7)

  RESQ-7 contains 13 items which are aggregated to 4 frequency and 4 intensity domain scores: heartburn (5 items), regurgitation (4 items), cough, hoarseness, difficulty swallowing (3 items), burping (1 item). Frequency questions are scored from 0-7 and intensity questions are scored from 0-5. The range of scores are 0-156 (0 meaning no symptoms, 156 being the worst).

  up to 8 weeks post treatment

• Gastroesophageal Reflux Disease Quality of Life (GERD-QoL)

  The questionnaire is composed of 6 items, 4 of which assess symptoms and situations considered positive predictors for GERD diagnosis: heartburn, regurgitations, disorders related to sleep and use of over the counter products. Other 2 items assess 2 nausea and epigastric pain. Participants answer each question about symptoms frequency during last week using a Likert like scale from 0 to 3 for positive predictors and from 3 to 0 for negative predictors. The maximum score that can be obtained is 18.

  up to 8 weeks post treatment

Secondary Outcomes (3)

• Insomnia severity index (ISI)

  up to 8 weeks post treatment

• Sleep Onset Latency (SOL)

  up to 8 weeks post treatment

• Wake After Sleep Onset (WASO)

  up to 8 weeks post treatment

Study Arms (1)

Web-based CBTI

EXPERIMENTAL

Participants will have 8 weeks to receive 6 therapy sessions. Content is dynamically driven by an animated therapist who guides the user through the program.

Behavioral: Web-based CBTI

Interventions

Web-based CBTI BEHAVIORAL

Sessions comprise a range of cognitive and behavioral techniques and psychoeducation including sleep hygiene. During the intervention period the participant will complete daily online sleep diaries. Additionally, participants will be asked to complete multiple questionnaires.

Web-based CBTI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with persistent reflux symptoms (GERDQ \>8) despite proton-pump inhibitor (PPI) therapy.
• Patients screened positive for chronic insomnia (insomnia severity index \[ISI\] ≥15).

You may not qualify if:

• Patients with major esophageal motility disorder, prior foregut surgeries, severe cardiopulmonary diseases, or major psychological comorbidities.
• Patients who report being in "poor" or "very poor" physical or mental health.
• Patients with sleep apnea (based on STOP-BANG questionnaire \>4)
• Patients with AUDIT score \>15, indicating alcohol dependence
• Patients regularly taking medications for sleep \>2 times per week who cannot stop the sleep aid at least 4 weeks prior to and during the study trial.
• Patients who have previously undergone CBT for insomnia (in person or online).

Sponsors & Collaborators

• University of Michigan: lead
• American Gastroenterological Association: collaborator

Study Sites (1)

University of Michigan GI Physiology Lab

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Joan Chen, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

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: Clinical Assistant Professor of Internal Medicine

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 5, 2019
• Study Start: April 15, 2019
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: June 23, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)