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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190312043036N1

Enrollment

160

Registered

2019-10-13

Start date

2019-03-22

Completion date

Unknown

Last updated

2020-02-24

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

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

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 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

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

Design outcomes

Primary

Measure	Time 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.;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.	—

Measure

Time 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.;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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public Contactabbas masjedi arani

Shahid Beheshti University of Medical Sciences

dr.abbas.masjediarani98@gmail.com+98 21 23871

Outcome results

None listed

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