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IRCT20190312043036N2 IRCT 2021-05-07 Shahid Beheshti University of Medical Sciences Comparative efficacy of unified protocol of transdiagnostic psychotherapy, metacognitive therapy, and mirtazapine in functional dyspepsia disorder UP, MCT, Comparative efficacy of unified protocol of transdiagnostic psychotherapy, metacognitive therapy, and mirtazapine treatment in the frequency and severity of physical symptoms, psychological symptoms, and quality of life in functional dyspepsia disorder 2021-05-22 anticipated 220 Complete https://irct.ir/trial/47148 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: 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, patients refer in odd days from 8 to 13 hour recruited in the up group, patients refer in odd days from 14- 19 hours recruited the metacognitive group, patients patient refer in even days from 8 to 13 hour recruited in mirtazapine treated group, patients refer in even days from 14- 19 hours recruited the placebo group, Blinding description: All the patients were single-blinded according to the treatments offering to them. 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: the second intervention: unified protocol of transdiagnostic treatment, 12 sessions 45 minutes psychotherapy based on the manual based approach of unified transdiagnostic psychotherapy by David Barlow, the aims of the session: 1:increasing present-focused emotion awareness, 2: increasing cognitive flexibility, 3: identifying and preventing patterns of emotion avoidance and maladaptive emotion-driven behaviors (EDBs), 4: increasing awareness and tolerance of emotion-related physical sensations, and 5: interoceptive and situation-based emotion-focused exposure. Intervention 3: Intervention group 3: 7.5 mg Mirtazapine for 12 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 4: Control group: usual treatment by omeprazole (20 mg, once daily, Sobhan Darou) and domperidone ( motidon, 10 mg, once daily, Abidi co.) for 12 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 Amir Sadeghi
Shahid Arababi Street Next to Ayatollah Taleghan Hospital, Yemen St. Martyr Chamran Highway,Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 2521 sepsiedu@gmail.com Shahid Beheshti University of Medical Sciences scientific Sepideh Batebi
Arabi st. Velenjack
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 2521 s.batebi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Suffering functional dyspepsia without comorbid diseases such as IBS or other digestive diseases if IBS was comorbid, the onset of functional dyspepsia symptoms would be prior to IBS 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 6 months lasted from the definite diagnosis of functional dyspepsia for all patients All patients had not taken any psychiatric drug and psychotherapy during the last 3 months ago 80-90% adherence to the targeted treatments and treatment as usual in any groups 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 Infected to H-pylori Being pregnant Having any physiopathology in Endoscopy Having any severe and intolerable side effects Patients need to take any medicine other than the prescribed drugs in the study during the study K30 Functional dyspepsia Behavior Behavior Treatment - Drugs Placebo 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: the second intervention: unified protocol of transdiagnostic treatment, 12 sessions 45 minutes psychotherapy based on the manual based approach of unified transdiagnostic psychotherapy by David Barlow, the aims of the session: 1:increasing present-focused emotion awareness, 2: increasing cognitive flexibility, 3: identifying and preventing patterns of emotion avoidance and maladaptive emotion-driven behaviors (EDBs), 4: increasing awareness and tolerance of emotion-related physical sensations, and 5: interoceptive and situation-based emotion-focused exposure. Intervention group 3: 7.5 mg Mirtazapine for 12 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 12 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. 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 2021-02-15 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Velenjak St. Tehran Tehran Iran (Islamic Republic of)