Clinical Improvement and in Quality of Life-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.
Behavioral: Psychological support
Other: No intervention
|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|
- 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 ]
- 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
- 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 ]
|Study Start Date:||March 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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|
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).
|Usansolo, Bizkaia, Spain, 48960|
|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|