An interventional study of Psychological support and No intervention in Psychogenic Dyspepsia, sponsored by Hospital Galdakao-Usansolo. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-06-21.
Sponsored by Hospital Galdakao-Usansolo · Not applicable, Interventional, and Supportive care
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.
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).
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's enrollment of 158 is above the median of 87 across 297 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Hospital Galdakao-Usansolo is the lead sponsor of 29 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
Patients of this group only received the conventional medical treatment, not receiving any psychological support
Other: No intervention
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).
Time frame: Participants will be followed at the recruit moment (t0) after treatment (t1) and six months after treatment (t2)
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
Time frame: Subjective clinical improvement it is measured after treatment (t1) and six months after treatment (t2)
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
Time frame: Participants will be followed at the recruit moment (t0) after treatment (t1) and six months after treatment (t2)
| Milestone | Psychological Support | No Psychological Support |
|---|---|---|
| Started | 76 | 82 |
| Completed | 60 | 72 |
| Not completed | 16 | 10 |
| Milestone | Psychological Support | No Psychological Support |
|---|---|---|
| Started | 60 | 72 |
| Completed | 58 | 70 |
| Not completed | 2 | 2 |
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).
| units on a scale | Psychological Support | No Psychological Support |
|---|---|---|
| Change from t0 to t1 in DRHS-severity symptoms | 73.72 ± 16.76 | 65.31 ± 17.60 |
| Change from t0 to t2 in DRHS-severity symptoms | 71.85 ± 20.46 | 64.89 ± 19.22 |
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
| Participants | Psychological Support | No Psychological Support |
|---|---|---|
| Better in relation to functional dyspepsia at T1 | 37 | 17 |
| Better in relation to functional dyspepsia at T2 | 36 | 26 |
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
| units on a scale | Psychological Support | No Psychological Support |
|---|---|---|
| Change From t0 to t1 in HADS-D | 8.95 ± 1.95 | 9.31 ± 2.00 |
| From t0 to t2in HADS-D | 9.09 ± 1.88 | 9.71 ± 2.01 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Psychological Support | — | — | — |
| No Psychological Support | — | — | — |
In certain analyzes we lose some subjects, for example when studying Subjective Clinical Improvement (here we have 60 patients in the experimental group and 69 in the control group)
| Age, Continuous(years) | Psychological Support | No Psychological Support | Total |
|---|---|---|---|
| Mean | 44.28 ± 14.06 | 47.09 ± 15.19 | 45.73 ± 14.67 |
| Sex: Female, Male(Participants) | Psychological Support | No Psychological Support | Total |
|---|---|---|---|
| Female | 64 | 66 | 130 |
| Male | 12 | 16 | 28 |
| Region of Enrollment(participants) | Psychological Support | No Psychological Support | Total |
|---|---|---|---|
| Spain | 76 | 82 | 158 |
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Hospital Galdakao-Usansolo