Completed

NCT Number: NCT01802710

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.

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Key information

Conditions

Psychogenic Dyspepsia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galdakao-Usansolo Hospital

Usansolo, Bizkaia, 48960, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

psychological support

Behavioral

No intervention

Other

Primary outcomes

Change From Baseline in DYSPEPSIA RELATED HEALTH SCALE (DRHS)

Time frame: 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 outcomes

Subjective Clinical Improvement

Time frame: 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 outcomes

Hospital Anxiety and Depression Scale

Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospital Galdakao-Usansolo

Other Gov

Registry information

Official study title

Influence of the Combined Psychological and Medical Treatment in the Improvement of Symptoms and Quality of Life in Patients With Functional Dyspepsia

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Mar 1, 2013
Registry last updated: Jun 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.