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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03904472
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : May 6, 2021
Sponsor:
Collaborator:
American Gastroenterological Association
Information provided by (Responsible Party):
Joan Chen, University of Michigan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Behavioral: Web-based CBTI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-arm Pilot Trial of Web-based Cognitive Behavioral Therapy for Insomnia (CBTI) in Gastroesophageal Reflux Disease (GERD) Patients With Insomnia
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Reflux Symptom Questionnaire-7-day recall (RESQ-7) [ Time Frame: 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).


  2. Gastroesophageal Reflux Disease Quality of Life (GERD-QoL) [ Time Frame: 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 Outcome Measures :
  1. Insomnia severity index (ISI) [ Time Frame: 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.

  2. Sleep Onset Latency (SOL) [ Time Frame: 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.

  3. Wake After Sleep Onset (WASO) [ Time Frame: up to 8 weeks post treatment ]
    This is based on the participants sleep diary and how many minutes they woke up after sleeping.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904472


Contacts
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Contact: Joan Chen, MD 734-647-7473 chenjoan@med.umich.edu

Locations
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United States, Michigan
University of Michigan GI Physiology Lab Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Elaine Brady, MBA    734-647-4794    embrady@med.umich.edu   
Sponsors and Collaborators
University of Michigan
American Gastroenterological Association
Investigators
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Principal Investigator: Joan Chen, MD University of Michigan
More Information
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Responsible Party: Joan Chen, Clinical Assistant Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT03904472    
Other Study ID Numbers: HUM00157452
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joan Chen, University of Michigan:
cognitive behavioral therapy
GERD
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
 Mental Disorders
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases