Important Correlation Between Anxiety and Reflux Symptoms in Patients With Gastroesophageal Reflux Disease

NCT06151067 | Completed DMC

• 1 other identifier: GERD_HADS
• Study Type: observational
• Target: 458
• Locations: 1 country
• Sites: 1

Brief Summary

Gastroesophageal reflux disease (GERD) is one of the most common gastroenterological disorders with a reported prevalence of 10% to 20% percent in Europe and the USA and less than 5% in Asia. GERD manifests as heartburn, regurgitation, retrosternal pain, cough, and in some cases dysphagia and holds the possible complication of a Barrett´s esophagus. GERD can appear as non-erosive (NERD) or erosive (ERD). Comorbid symptoms of anxiety and depression are common in GERD patients: The association between anxiety or depression and reflux symptoms has been investigated in previous studies under the aspects of whether existing reflux symptomatology leads to increased anxiety and depression or whether anxiety and depression lead to more severe reflux symptoms. There is a an interaction between GERD and psychosocial disorders. A long duration of GERD was associated with higher levels of anxiety and depression, and women were more likely to have these symptoms. In patients with Barrett's esophagus, a complication of GERD in which the mucosal cells of the esophagus, under constant exposure to stomach acid, change into a different type of cell normally found in the intestinal tract, rates of anxiety and depression have been reported to be three to five times higher than in the general population. Anxiety and depression as well as adverse events in life are also independent risk factors for NERD. Patients with NERD show an increased risk for anxiety compared with patients with ERD. The reporting of somatic symptoms is multifactorial and influenced by psychosocial factors such as socioeconomic status, sex and mental distress. A high somatic symptom load is known to increase anxiety related to health issues, psychological distress and health care utilization. The increased sensation to visceral stimuli in which anxiety and depression play an important role has been discussed as visceral hypersensitivity. Several studies of patients with reflux symptoms have used the Hopsital Anxiety and Depression Scale (HADS) score as a measure of anxiety and depression and have reported higher anxiety scores than depression scores for this cohort. The aim of this study was to assess anxiety and depression levels of patients with physiological as well as with pathological DeMeester scores. Further the modulation of anxiety on the severity of reflux symptoms such as fullness, heartburn and dysphagia is examined.

Conditions

GERD - Gastro-Esophageal Reflux Disease; Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• Anxiety and depression

  Anxiety and depression are evaluated during diagnostic workup of patients using the HADS questionnaire. In evaluating the HADS scores were grouped into subscales of HADS-A of =8 and \>8 as "anxious" and those on the subscale of HADS-D of 8 and over 8 as "depressed". It is differentiated between mildly (HADS score on the subscale 8-10), moderately (HADS 11 - 14) and severely (HADS 15 - 21) anxious or depressed.

  During diagnostic workup of patients with gastroesophageal reflux disease as baseline characteristics

Interventions

High-Resolution Manometry, Upper-GI endoscopy, pH-Impedance testing DIAGNOSTIC_TEST

High-Resolution Manometry Upper-GI endoscopy pH-Impedance testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptoms of reflux (heartburn, regurgitation, retrosternal pain) who present at the consultation hour at the department of General, Visceral, Tumor and Transplantation Surgery of the University Hospital of Cologne were included into the study. All patients underwent Upper GI Endoscopy, High-Resolution Manometry and pH-Impedance testing who completed the HADS questionnaire were included into the study.

You may qualify if:

• Patients with symptoms of reflux who present at the consultation hour at the department of General, Visceral, Tumor and Transplantation Surgery of the University Hospital of Cologne
• Patients who underwent Upper GI Endoscopy, High-Resolution Manometry and pH-Impedance testing who completed the HADS questionnaire were included into the study.

You may not qualify if:

• Patients without knowledge of the German language
• Patients who did not complete the HADS questionnaire
• Patients who did not complete all diagnostic testing

Sponsors & Collaborators

• Evangelic Hospital Kalk Cologne: lead

Study Sites (1)

Department of General, Visceral, Tumor and Transplantation Surgery, University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Anxiety Disorders

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Jessica M Leers, Prof.

  Department of Functional Upper GI Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Jessica Leers

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 30, 2023
• Study Start: January 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

DE (1)