CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 158 enrolled
Drug / intervention
Psychological support +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01802710
NCT01802710N/ACompleted

Influence of the Combined Psychological and Medical Treatment in the Improvement of Symptoms and Quality of Life in Patients With Functional Dyspepsia

Hospital Galdakao-Usansolo·interventional·Posted Mar 1, 2013·Updated Jun 21, 2019

In Brief

A clinical study evaluating Psychological support and No intervention for Psychogenic Dyspepsia. Completed, enrolled 158 participants across 1 site.

Detailed Summary

Functional dyspepsia (FD)is defined as the presence of symptoms thought to originate in the gastroduodenal region with no evidence of structural disease that is likely to explain the symptoms. The cause of this condition is unclear, not being a recognized treatment for it. The conventional treatments for those patients are symptom based. Unfortunately, these medications are not very effective. Patients with FD report poorer health status, mental health, and social functioning than patients with structural gastrointestinal pathology. Our aim is to compare a combined intervention (medical plus psychological intervention) versus conventional intervention (medical intervention)in regard to the health related quality of life, symptomatology, anxiety and depression of those patients. The investigators hypothesized that compared with conventional intervention a combined intervention would yield significantly better short (after treatment) and medium term (six months after treatment) improvement of health related quality of life and symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 1, 2013
Enrollment StartMar 1, 2009
Primary CompletionSep 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 13.3 years ago

Interventions

Psychological supportbehavioral

No interventionother