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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03904472
• Other study ID #: HUM00157452
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: March 25, 2022

Study information

• Verified date: June 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 25, 2022
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan GI Physiology Lab	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	American Gastroenterological Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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