Psychogenic Dyspepsia
Conditions
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).
Interventions
BEHAVIORALPsychological support
OTHERNo intervention
Sponsors
Hospital Galdakao-Usansolo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in DYSPEPSIA RELATED HEALTH SCALE (DRHS) | Participants will be followed at the recruit moment (t0) after treatment (t1) and six months after treatment (t2) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Clinical Improvement | Subjective clinical improvement it is measured after treatment (t1) and six months after treatment (t2) | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale | Participants will be followed at the recruit moment (t0) after treatment (t1) and six months after treatment (t2) | 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 |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) progressive-muscle relaxation according to Jacobson
Psychological support + conventional medical treatment | 76 |
| No Psychological Support Patients of this group only received the conventional medical treatment, not receiving any psychological support
No psychological intervention | 82 |
| Total | 158 |
Baseline characteristics
| Characteristic | Psychological Support | No Psychological Support | Total |
|---|---|---|---|
| Age, Continuous | 44.28 years STANDARD_DEVIATION 14.06 | 47.09 years STANDARD_DEVIATION 15.19 | 45.73 years STANDARD_DEVIATION 14.67 |
| Region of Enrollment Spain | 76 participants | 82 participants | 158 participants |
| Sex: Female, Male Female | 64 Participants | 66 Participants | 130 Participants |
| Sex: Female, Male Male | 12 Participants | 16 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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)
Population: the number analyzed in the rows differs from overall number analyzed because, as it is occur in follow-up studies, patients were lost from T0 to T1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychological Support | Change From Baseline in DYSPEPSIA RELATED HEALTH SCALE (DRHS) | Change from t0 to t1 in DRHS-severity symptoms | 73.72 units on a scale | Standard Deviation 16.76 |
| Psychological Support | Change From Baseline in DYSPEPSIA RELATED HEALTH SCALE (DRHS) | Change from t0 to t2 in DRHS-severity symptoms | 71.85 units on a scale | Standard Deviation 20.46 |
| No Psychological Support | Change From Baseline in DYSPEPSIA RELATED HEALTH SCALE (DRHS) | Change from t0 to t1 in DRHS-severity symptoms | 65.31 units on a scale | Standard Deviation 17.6 |
| No Psychological Support | Change From Baseline in DYSPEPSIA RELATED HEALTH SCALE (DRHS) | Change from t0 to t2 in DRHS-severity symptoms | 64.89 units on a scale | Standard Deviation 19.22 |
Secondary
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Psychological Support | Subjective Clinical Improvement | Better in relation to functional dyspepsia at T1 | 37 Participants |
| Psychological Support | Subjective Clinical Improvement | Better in relation to functional dyspepsia at T2 | 36 Participants |
| No Psychological Support | Subjective Clinical Improvement | Better in relation to functional dyspepsia at T1 | 17 Participants |
| No Psychological Support | Subjective Clinical Improvement | Better in relation to functional dyspepsia at T2 | 26 Participants |
Other Pre-specified
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)
Population: The number analyzed in the rows differs from overall number analyzed because, as it is occur in follow-up studies, patients were lost from T0 to T2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychological Support | Hospital Anxiety and Depression Scale | Change From t0 to t1 in HADS-D | 8.95 units on a scale | Standard Deviation 1.95 |
| Psychological Support | Hospital Anxiety and Depression Scale | From t0 to t2in HADS-D | 9.09 units on a scale | Standard Deviation 1.88 |
| No Psychological Support | Hospital Anxiety and Depression Scale | Change From t0 to t1 in HADS-D | 9.31 units on a scale | Standard Deviation 2 |
| No Psychological Support | Hospital Anxiety and Depression Scale | From t0 to t2in HADS-D | 9.71 units on a scale | Standard Deviation 2.01 |