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IRCT20190312043036N1 IRCT 2019-10-13 Shahid Beheshti University of Medical Sciences effect of metacognitive therapy on patients with functional dyspepsia comparison of  efficacy  of metacognitive therapy and drug treatment in the  frequency and severity of physical symptoms, psychological symptoms and quality of life in patients with functional dyspepsia 2019-03-22 anticipated 160 Complete https://irct.ir/trial/38432 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first, the available sample was selected from those who referred to the gastroenterology clinic of Taleghani Hospital and the affiliated centers. Finally, based on the simple random sampling by throwing a dice, the outcomes 1 and 2 were considered for assigning the patients to the metacognitive therapy group, the outcomes 3 and 4 for assigning the patients to the drug treatment group and the outcomes 5 and 6 for the control group. N/A Functional dyspepsia. Intervention 1: Intervention group 1: metacognitive therapy, 10-session 45-minute treatment based on the Adrian Wells protocol approach to metacognitive therapy focused on anxiety protocol; First session: Formulation; Second session: Mindfulness training; Third to sixth sessions: Working on negative metacognitive beliefs; sessions 7 and 8: Challenging Positive metacognitive beliefs; sessions 9 and 10: New processing style training and relapse prevention training with common treatment: omeprazole and domperidone 25 mg for 10 weeks, once daily (made by Sobhan company) plus adhering to recommended diet and regular exercise. Intervention 2: Intervention group 2: 25 mg Nortriptyline for 10 weeks, once daily, Sobhan manufacturer with usual treatment: omeprazole 20 mg and domperidone 10 mg for 10 weeks, once daily, Sobhan manufacturer, and adhering to recommended diet and regular exercise. Intervention 3: Control group: usual treatment by omeprazole (20 mg, once daily, Sobhan Darou) and domperidone ( motidon, 10 mg, once daily, Abidi co.) for 10 weeks, and recommended diet and regular exercise. Yes - There is a plan to make this available What will be shared: results, tables and treatment protocol When: 6 months after publication To whom: Qualified applicants (graduates of medical, specialty and fellowship, psychiatrists, clinical and health psychologists) Conditions: Repeated measure analysis Where to obtain: Sepideh Batebi s.batebi@sbmu.ac.ir How to obtain: The applicants must first submit their application by an academic email to the correspondent, and then, the requests will be checked within one week and if approved the data will be sent. Comments:
public abbas masjedi arani
Shahid Arababi Street Next to Ayatollah Taleghan Hospital, Yemen St. Martyr Chamran Highway,Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 dr.abbas.masjediarani98@gmail.com Shahid Beheshti University of Medical Sciences scientific Abbas Masjedi Arani
Arabi st. Velenjack
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 info@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Having functional dyspepsia without comorbid disease such as IBS or other digestive disease Not having any variety of chronic somatic diseases No simultaneous use of other psychiatric drugs No dependency on or abusing substance Partial adherence to diet and exercise Absence of severe psychiatric disorders Age range between 18 and 55 Having reading and writing skills 18 years 55 years Both Unwillingness to participate in the research for any reason Inability of the patient to access the medical center Having chronic physical impairment or physical inability Having a severe mental disorder Substance use or dependence Patients need to take any medicine other than the prescribed drugs in the study during the study K30 Functional dyspepsia Behavior Treatment - Drugs Other Intervention group 1: metacognitive therapy, 10-session 45-minute treatment based on the Adrian Wells protocol approach to metacognitive therapy focused on anxiety protocol; First session: Formulation; Second session: Mindfulness training; Third to sixth sessions: Working on negative metacognitive beliefs; sessions 7 and 8: Challenging Positive metacognitive beliefs; sessions 9 and 10: New processing style training and relapse prevention training with common treatment: omeprazole and domperidone 25 mg for 10 weeks, once daily (made by Sobhan company) plus adhering to recommended diet and regular exercise. Intervention group 2: 25 mg Nortriptyline for 10 weeks, once daily, Sobhan manufacturer with usual treatment: omeprazole 20 mg and domperidone 10 mg for 10 weeks, once daily, Sobhan manufacturer, and adhering to recommended diet and regular exercise. Control group: usual treatment by omeprazole (20 mg, once daily, Sobhan Darou) and domperidone ( motidon, 10 mg, once daily, Abidi co.) for 10 weeks, and recommended diet and regular exercise. Symptoms of functional dyspepsia. Timepoint: Pre test, post test and follow up. Method of measurement: Leeds dyspepsia questionnaire and clinical interview based on Rome IV. Depression. Timepoint: Pre test, post test and follow up three months after treatment. Method of measurement: Hamilton depression questionnaire. Anxiety. Timepoint: Pre test, post test and follow up three months after treatment. Method of measurement: Hamilton anxiety questionnaire. Quality of life. Timepoint: Pre test, post test and follow up three months after treatment. Method of measurement: Nepean dyspepsia index for quality of life. Cortisol. Timepoint: Pre test, post test and follow up three months after treatment. Method of measurement: Blood Cortisol Test. Emotional regulation. Timepoint: Pre test, post test and follow up three months after treatment. Method of measurement: Questionnaire for difficulty in emotional regulation. Emotional processing. Timepoint: Pre test, post test and follow up three months after treatment. Method of measurement: Baker's emotional processing questionnaire. Shahid Beheshti University of Medical Sciences Approved 2018-01-16 Ethics committee of Shahid Beheshti university of medical science Velenjak st Tehran Tehran Iran (Islamic Republic of)