Gastroesophageal Reflux Disease
Conditions
Keywords
cognitive behavioral therapy, GERD
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.
Interventions
BEHAVIORALWeb-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.
Sponsors
American Gastroenterological Association
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reflux Symptom Questionnaire-7-day recall (RESQ-7) | up to 8 weeks post treatment | 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). |
| Gastroesophageal Reflux Disease Quality of Life (GERD-QoL) | up to 8 weeks post treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia severity index (ISI) | up to 8 weeks post treatment | 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. |
| Sleep Onset Latency (SOL) | up to 8 weeks post treatment | This is based on the participants sleep diary and how many minutes it took the participants to fall asleep. |
| Wake After Sleep Onset (WASO) | up to 8 weeks post treatment | This is based on the participants sleep diary and how many minutes they woke up after sleeping. |
Countries
United States
Outcome results
None listed