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Comparative efficacy of unified protocol of transdiagnostic psychotherapy, metacognitive therapy, and mirtazapine in functional dyspepsia disorder

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190312043036N2
Enrollment
220
Registered
2021-05-07
Start date
2021-05-22
Completion date
Unknown
Last updated
2021-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional dyspepsia. Functional dyspepsia

Interventions

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Sadeghi

Shahid Beheshti University of Medical Sciences

sepsiedu@gmail.com+98 21 2243 2521

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026