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Completed

NCT Number: NCT03904472

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

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan GI Physiology Lab

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Web-based CBTI

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • American Gastroenterological Association

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2019
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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