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

University of Michigan46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastroesophageal Reflux Disease

Interventions

Web-based CBTIBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan GI Physiology Lab

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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).