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

Study Overview
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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.

Official Title
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Single-arm Pilot Trial of Web-based Cognitive Behavioral Therapy for Insomnia (CBTI) in Gastroesophageal Reflux Disease (GERD) Patients With Insomnia

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Behavioral: Web-based CBTI


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based CBTI<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia severity index (ISI) | ISI is a 7-item psychometrically validated measure used to rate insomnia.The total score ranges from 0-28 where higher values indicate increased severity of insomnia. | up to 8 weeks post treatment | 
| Sleep Onset Latency (SOL) | This is based on the participants sleep diary and how many minutes it took the participants to fall asleep. | up to 8 weeks post treatment | 
| Wake After Sleep Onset (WASO) | This is based on the participants sleep diary and how many minutes they woke up after sleeping. | up to 8 weeks post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive behavioral therapy, GERD