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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-15

Study Completion Date

2022-03-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Web-based CBTI

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.

Group Type EXPERIMENTAL

Web-based CBTI

Intervention Type 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.

Interventions

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Web-based CBTI

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No