Back to resultsCognitive Behavioral Therapy for Insomnia (CBTI) in GERD Patients With Insomnia
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-based CBTI
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring cognitive behavioral therapy, GERD
Eligibility Criteria
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).
Sites / Locations
- University of Michigan GI Physiology Lab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Web-based CBTI
Arm 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.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
Sleep Onset Latency (SOL)
This is based on the participants sleep diary and how many minutes it took the participants to fall asleep.
Wake After Sleep Onset (WASO)
This is based on the participants sleep diary and how many minutes they woke up after sleeping.
Full Information
NCT ID
NCT03904472
First Posted
April 3, 2019
Last Updated
June 22, 2022
Sponsor
University of Michigan
Collaborators
American Gastroenterological Association
1. Study Identification
Unique Protocol Identification Number
NCT03904472
Brief Title
Cognitive Behavioral Therapy for Insomnia (CBTI) in GERD Patients With Insomnia
Official Title
Single-arm Pilot Trial of Web-based Cognitive Behavioral Therapy for Insomnia (CBTI) in Gastroesophageal Reflux Disease (GERD) Patients With Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
March 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
American Gastroenterological Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
cognitive behavioral therapy, GERD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Web-based CBTI
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Web-based CBTI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reflux Symptom Questionnaire-7-day recall (RESQ-7)
Description
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).
Time Frame
up to 8 weeks post treatment
Title
Gastroesophageal Reflux Disease Quality of Life (GERD-QoL)
Description
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.
Time Frame
up to 8 weeks post treatment
Secondary Outcome Measure Information:
Title
Insomnia severity index (ISI)
Description
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.
Time Frame
up to 8 weeks post treatment
Title
Sleep Onset Latency (SOL)
Description
This is based on the participants sleep diary and how many minutes it took the participants to fall asleep.
Time Frame
up to 8 weeks post treatment
Title
Wake After Sleep Onset (WASO)
Description
This is based on the participants sleep diary and how many minutes they woke up after sleeping.
Time Frame
up to 8 weeks post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Chen, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan GI Physiology Lab
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cognitive Behavioral Therapy for Insomnia (CBTI) in GERD Patients With Insomnia
We'll reach out to this number within 24 hrs