Psychogenic DyspepsiaNCT01802710
Clinical Improvement and in Quality of Life-Functional Dyspepsia-
A study testing Psychological support in people with Psychogenic Dyspepsia, run by Hospital Galdakao-Usansolo at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psychogenic Dyspepsia
- What is being tested?
- Psychological support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the Combined Psychological and Medical Treatment in the Improvement of Symptoms and Quality of Life in Patients With 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.
Read the 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).
- Conditions
- Psychogenic Dyspepsia
- Being tested
- Psychological support, No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological supportBehavioural
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Psychological support | Experimental | 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 Receives: Behavioral: Psychological support |
| No psychological support | Active comparator | Patients of this group only received the conventional medical treatment, not receiving any psychological support Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Participants will be followed at the recruit moment (t0) after treatment (t1) and six months after treatment (t2)
Secondary outcomes (1)
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
Measured: Subjective clinical improvement it is measured after treatment (t1) and six months after treatment (t2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startMar 2009
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychogenic DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Galdakao-Usansolo
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Miren Orive Calzada, Hospital Galdakao-Usansolo
- Investigators
- Victor Manuel Orive, Doctor, Principal investigator, Basurto University HospitalJose Luis Cabriada, Doctor, Study chair, Hospital Galdakao-UsansoloAitor Orive, Doctor, Study chair, Hospital Galdakao-UsansoloBegoña Matellanes, Psychology, Study chair, University of DeustoMaria Josefa Ulloa, Nurse, Study chair, Basurto University HospitalJesus Angel Padierna, Doctor, Study chair, Hospital Galdakao-UsansoloAntonio Escobar, Doctor, Study chair, Basurto University HospitalAntonio Bernal, Doctor, Study chair, Hospital Galdakao-Usansolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802710
- Sponsor's protocol ID
- 2008111005
- Status last verified
- Mar 2019
- First submitted
- 25 Feb 2013
- Last updated
- 21 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Orive M, Barrio I, Orive VM, Matellanes B, Padierna JA, Cabriada J, Orive A, Escobar A, Quintana JM. A randomized controlled trial of a 10 week group psychotherapeutic treatment added to standard medical treatment in patients with functional dyspepsia. J Psychosom Res. 2015 Jun;78(6):563-8. doi: 10.1016/j.jpsychores.2015.03.003. Epub 2015 Mar 11.
PubMed 25791668
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Combined Psychological and Medical Treatment in the Improvement of Symptoms and Quality of Life in Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT01802710
- Acronym / sponsor ID
- 2008111005
- Conditions
- Psychogenic Dyspepsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Hospital Galdakao-UsansoloOther government
- Study start
- Mar 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Posted 21 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychological support | Experimental | Behavioral: Psychological supportTen 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 |
| No psychological support | Active comparator | Other: No interventionPatients of this group only received the conventional medical treatment, not receiving any psychological support |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological support | Behavioural | Psychological support |
| No intervention | Other | No psychological support |
Primary outcome
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).
1 secondary outcome
Subjective Clinical Improvement
Time frame: Subjective clinical improvement it is measured after treatment (t1) and six months after treatment (t2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25791668Orive M, Barrio I, Orive VM, Matellanes B, Padierna JA, Cabriada J, Orive A, Escobar A, Quintana JM. A randomized controlled trial of a 10 week group psychotherapeutic treatment added to standard medical treatment in patients with functional dyspepsia. J Psychosom Res. 2015 Jun;78(6):563-8. doi: 10.1016/j.jpsychores.2015.03.003. Epub 2015 Mar 11.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Manuel Orive, Doctor principal investigator
Basurto University Hospital
Jose Luis Cabriada, Doctor study chair
Hospital Galdakao-Usansolo
Aitor Orive, Doctor study chair
Hospital Galdakao-Usansolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological support in people with Psychogenic Dyspepsia, run by Hospital Galdakao-Usansolo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01802710, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.