Clinical trial NCT01802710: Clinical Improvement and in Quality of Life-Functional Dyspepsia-
Official title: Influence of the Combined Psychological and Medical Treatment in the Improvement of Symptoms and Quality of Life in Patients With Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychogenic Dyspepsia
Lead sponsor: Hospital Galdakao-Usansolo
Sponsor class: OTHER_GOV
First posted: 2013-03-01
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility 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

Primary outcomes:
measure: Change From Baseline in DYSPEPSIA RELATED HEALTH SCALE (DRHS)
timeFrame: Participants will be followed at the recruit moment (t0) after treatment (t1) and six months after treatment (t2)
Secondary outcomes:
measure: Subjective Clinical Improvement
timeFrame: Subjective clinical improvement it is measured after treatment (t1) and six months after treatment (t2)
Other outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: Participants will be followed at the recruit moment (t0) after treatment (t1) and six months after treatment (t2)
Locations:
city: Usansolo
country: Spain
facility: Galdakao-Usansolo Hospital
state: Bizkaia
Study officials:
affiliation: Basurto University Hospital
name: Victor Manuel Orive, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Galdakao-Usansolo
name: Jose Luis Cabriada, Doctor
role: STUDY_CHAIR
affiliation: Hospital Galdakao-Usansolo
name: Aitor Orive, Doctor
role: STUDY_CHAIR
affiliation: University of Deusto
name: Begoña Matellanes, Psychology
role: STUDY_CHAIR
affiliation: Basurto University Hospital
name: Maria Josefa Ulloa, Nurse
role: STUDY_CHAIR
affiliation: Hospital Galdakao-Usansolo
name: Jesus Angel Padierna, Doctor
role: STUDY_CHAIR
affiliation: Basurto University Hospital
name: Antonio Escobar, Doctor
role: STUDY_CHAIR
affiliation: Hospital Galdakao-Usansolo
name: Antonio Bernal, Doctor
role: STUDY_CHAIR
References:
citation: 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.