Clinical Improvement and in Quality of Life-Functional Dyspepsia-

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Miren Orive Calzada, Hospital Galdakao-Usansolo
ClinicalTrials.gov Identifier:
NCT01802710
First received: February 25, 2013
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Functional Dyspepsia
Behavioral: Psychological support
Other: No intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Influencia Del Tratamiento psicológico Combinado Con el médico en la mejoría clínica y de la Calidad de Vida en Los Pacientes Con Dispepsia Funcional

Resource links provided by NLM:


Further study details as provided by Hospital Galdakao-Usansolo:

Primary Outcome Measures:
  • Change from baseline in DYSPEPSIA RELATED HEALTH SCALE (DRHS) [ Time Frame: Participants will be followed at the recruit momento (t0) after treatment (t1) and six months after treatment (t2) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Subjective clinical improvement [ Time Frame: Participants will be followed at the recruit momento (t0) after treatment (t1) and six months after treatment (t2) ] [ Designated as safety issue: Yes ]
    Subjective clinical improvement was measured by a question about how patients feel in regard to the functional dyspepsia ("In relation to functional dyspepsia, how would you rate your health now? a)much better; b) quite a lot better; c) somewhat better; d) about the same; e) somewhat worse; f) quite a lot worse; g) much worse


Other Outcome Measures:
  • Hospital Anxiety and Depression Scale [ Time Frame: Participants will be followed at the recruit momento (t0) after treatment (t1) and six months after treatment (t2) ] [ Designated as safety issue: Yes ]

Enrollment: 158
Study Start Date: March 2009
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychological support
Ten weekly sessions, which the first 8 were in group and the last 2 were individuals. It consists on a) an informational session; b) Beck's cognitive-behavioural therapy; and c) proressive-muscle relaxation according to Jacobson
Behavioral: Psychological support
Active Comparator: No psychological support
Patients of this group only received the conventional medical treatment, not receiving any psychological support
Other: No intervention

Detailed Description:

Patients were recluted from the digestive services of Galdakao-Usansolo and Basurto hospitals. They were randomly allocated to the control or experimental group. 82 patients were included in the control group and 76 in the experimental group.

Regarding the intervention, the treatment of the control group was a conventional (medical) intervention. It was focused on the most bothersome symptom. Prokinetic (for example cinitaprida) or antisecretory agent (for example omeprazol) was prescribed in standard dose. Experimental group received the combined intervention (medical plus psychological intervention). The psychological support consisted of ten weekly sessions, which the first 8 were in group and the last 2 were individuals. In those sessions the patients received a) an information session to increase the patients' knowledge of fucntional dyspepsia; b) a Beck's cognitive-behavioural therapy focused on modifying the influence of some cognitive issues to gastrointestinal symptoms; c) and progressive-muscle relaxation according to Jacobson, with the aim to provide the ability to relax in certain stress situations. This technique was created for reducing anxiety by alternately tensing and relaxing the muscles.

All the patients completed all the self questionnaires at baseline (t0), at the end of the treatment (T1) and at six months follow up (T2). The health related quality of life was assessed by the Dyspepsia Related Health Scale (DRHS), and anxiety and depression were assessed by the Hospital Anxiety and Depression Scale (HADS). Finally, the subjective clinical improvement was also considered and it was measured by a question about how they feel in regard to the functional dyspepsia, with five alternatively responses (a) Much better, b) quite a lot better, c) somewhat better, d) about the same, e) somewhat worse, f) quite a lot worse, g) much worse).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • to have chronic upper abdominal symptoms consistent with ROME III criteria for functional dyspepsia
  • to have an endoscopy to exclude structural organic causes at the time of the recruitment

Exclusion Criteria:

  • to have any organic pathology that could explain the dyspeptic symptoms
  • to be using non-steroidal anti-inflammatory drugs (NSAIDs)
  • to suffer physical or psychological impairments preventing them from properly completing the questionnaires
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802710

Locations
Spain
Galdakao-Usansolo Hospital
Usansolo, Bizkaia, Spain, 48960
Sponsors and Collaborators
Hospital Galdakao-Usansolo
Investigators
Principal Investigator: Victor Manuel Orive, Doctor Basurto University Hospital
Study Chair: Jose Luis Cabriada, Doctor Hospital Galdakao-Usansolo
Study Chair: Aitor Orive, Doctor Hospital Galdakao-Usansolo
Study Chair: Begoña Matellanes, Psychology University of Deusto
Study Chair: Maria Josefa Ulloa, Nurse Basurto University Hospital
Study Chair: Jesus Angel Padierna, Doctor Hospital Galdakao-Usansolo
Study Chair: Antonio Escobar, Doctor Basurto University Hospital
Study Chair: Antonio Bernal, Doctor Hospital Galdakao-Usansolo
  More Information

No publications provided

Responsible Party: Miren Orive Calzada, Msc, Hospital Galdakao-Usansolo
ClinicalTrials.gov Identifier: NCT01802710     History of Changes
Other Study ID Numbers: 2008111005
Study First Received: February 25, 2013
Last Updated: February 28, 2013
Health Authority: spain: Ethics Committee of Clinical Research of Galdakao-Usansolo Hospital

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on August 26, 2014