Clinical Improvement and in Quality of Life-Functional Dyspepsia-

NCT01802710 | Completed Results

• 1 other identifier: 2008111005
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in DYSPEPSIA RELATED HEALTH SCALE (DRHS)

  The Dyspepsia Related Health Scale (DRHS) is a self-reported dyspepsia-specific questionnaire that consists of four scales: severity of common symptoms, pain intensity, pain disability, and satisfaction with dyspepsia-related health. The score, for each scale, ranges between 0 and 100, with 0 representing the most severe situation and 100 the least severe. It also yields a global score that ranges from 0 to 100, with higher scores indicating less severe dyspepsia. The adapted and validated Spanish version of this questionnaire is known as QoL-PEI (Quality of Life in relation to Stomach and Intestinal Problems Questionnaire). Its reliability was found to be satisfactory (Cronbach's alpha 0.92). Its factorial analysis confirmed the four scales found by the DRHS but added a global score scale. The convergent validity was moderate (0.54).

  Participants will be followed at the recruit moment (t0) after treatment (t1) and six months after treatment (t2)

Secondary Outcomes (1)

• Subjective Clinical Improvement

  Subjective clinical improvement it is measured after treatment (t1) and six months after treatment (t2)

Other Outcomes (1)

• Hospital Anxiety and Depression Scale

  Participants will be followed at the recruit moment (t0) after treatment (t1) and six months after treatment (t2)

Study Arms (2)

Psychological support

EXPERIMENTAL

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) progressive-muscle relaxation according to Jacobson

Behavioral: Psychological support

No psychological support

ACTIVE COMPARATOR

Patients of this group only received the conventional medical treatment, not receiving any psychological support

Other: No intervention

Interventions

Psychological support BEHAVIORAL

Psychological support

No intervention OTHER

No psychological support

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead

Study Sites (1)

Galdakao-Usansolo Hospital

Usansolo, Bizkaia, 48960, Spain

Location

Related Publications (1)

• Orive M, Barrio I, Orive VM, Matellanes B, Padierna JA, Cabriada J, Orive A, Escobar A, Quintana JM. A randomized controlled trial of a 10 week group psychotherapeutic treatment added to standard medical treatment in patients with functional dyspepsia. J Psychosom Res. 2015 Jun;78(6):563-8. doi: 10.1016/j.jpsychores.2015.03.003. Epub 2015 Mar 11.

  PMID: 25791668 RESULT

Results Point of Contact

• Title: Dra Miren Orive
• Organization: Hospital Galdakao-Usansolo

miren.orivecalzada@osakidetza.net

0034 944007105

Study Officials

• Victor Manuel Orive, Doctor

  Basurto University Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: March 1, 2013
• Study Start: March 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 21, 2019
• Results First Posted: June 21, 2019

Record last verified: 2019-03

Locations

ES (1)