Clinical Improvement and in Quality of Life-Functional Dyspepsia-

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

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 Overview

• Status: Completed
• Conditions: Psychogenic Dyspepsia
• Intervention / Treatment: Other: No intervention; Behavioral: Psychological support

Detailed Description

Patients were recruited 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 cinitapride) or antisecretory agent (for example omeprazole) 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 functional 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).

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Bizkaia
    • Usansolo, Bizkaia, Spain, 48960
      • Galdakao-Usansolo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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) progressive-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Clinical Improvement	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	Subjective clinical improvement it is measured after treatment (t1) and six months after treatment (t2)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale	It is a 14-item measure: 7 items evaluate depression (the HADS-D subscale) and 7 evaluate anxiety (the HADS-A subscale). For each subscale items range from 0 to 21. A subscale score of 0-7 indicates the absence of anxiety or depression; a score of 8-10 indicates a possible case of anxiety or depression; and a score of 11 or higher indicates the presence of anxiety or depression. It has been adapted and validated in a Spanish population	Participants will be followed at the recruit moment (t0) after treatment (t1) and six months after treatment (t2)

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 25, 2013
• First Submitted That Met QC Criteria: February 28, 2013
• First Posted (Estimate): March 1, 2013

Study Record Updates

• Last Update Posted (Actual): June 21, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: 2008111005