Completed

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

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What is being tested

Psychological support

+ No intervention

BehavioralOther
Who is being recruted

From 18 to 80 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: March 2009
See protocol details

Summary

Principal SponsorHospital Galdakao-Usansolo
Last updated: June 21, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2009

Actual date on which the first participant was enrolled.

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).

Principal SponsorHospital Galdakao-Usansolo
Last updated: June 21, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

158 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
to have an endoscopy to exclude structural organic causes at the time of the recruitment

to have chronic upper abdominal symptoms consistent with ROME III criteria for functional dyspepsia

3 exclusion criteria prevent from participating
to be using non-steroidal anti-inflammatory drugs (NSAIDs)

to have any organic pathology that could explain the dyspeptic symptoms

to suffer physical or psychological impairments preventing them from properly completing the questionnaires

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Galdakao-Usansolo Hospital

Usansolo, SpainOpen Galdakao-Usansolo Hospital in Google Maps
CompletedOne Study Center