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

University of Michigan

Status: Completed

Conditions: Gastroesophageal Reflux Disease

Treatments: Behavioral: Web-based CBTI

Study type: Interventional

Funder types: Other

Identifiers

NCT03904472

HUM00157452

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Web-based CBTI

Experimental group

Description:

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.

Treatment:

Behavioral: Web-based CBTI