Clinical Improvement and in Quality of Life-Functional Dyspepsia-

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.

Conditions

• Psychogenic Dyspepsia

Interventions

BEHAVIORAL

Psychological support

OTHER

No intervention

Sponsors & Collaborators

• Hospital Galdakao-Usansolo

  lead OTHER_GOV

Principal Investigators

• Victor Manuel Orive, Doctor · Basurto University Hospital

• Jose Luis Cabriada, Doctor · Hospital Galdakao-Usansolo

• Aitor Orive, Doctor · Hospital Galdakao-Usansolo

• Begoña Matellanes, Psychology · University of Deusto

• Maria Josefa Ulloa, Nurse · Basurto University Hospital

• Jesus Angel Padierna, Doctor · Hospital Galdakao-Usansolo

• Antonio Escobar, Doctor · Basurto University Hospital

• Antonio Bernal, Doctor · Hospital Galdakao-Usansolo

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-03-31

Primary Completion

2012-09-30

Completion

2012-12-31

Countries

• Spain

Study Locations