Clinical Improvement and in Quality of Life-Functional Dyspepsia-
Condition: Psychogenic Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional

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).
    

Intervention name(s): Psychological support; No intervention
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care