Cognitive Behavioral Therapy for Insomnia (CBTI) in GERD Patients With Insomnia
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|ClinicalTrials.gov Identifier: NCT03904472|
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : April 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease||Behavioral: Web-based CBTI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 2020|
|Estimated Study Completion Date :||April 2021|
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.
- 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).
- 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.
- 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.
- 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.
- 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.
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
|Contact: Joan Chen, MDemail@example.com|
|United States, Michigan|
|University of Michigan GI Physiology Lab||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Elaine Brady, MBA 734-647-4794 firstname.lastname@example.org|
|Principal Investigator:||Joan Chen, MD||University of Michigan|