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IRCT20260509069319N1 IRCT 2026-06-02 Islamic Azad University Effectiveness of Mindfulness-Based Cognitive Therapy on Functional Dyspepsia The Effectiveness of Mindfulness-Based Cognitive Therapy on Anxiety,Irrational Beliefs, quality of life and Self- compassion in patients with functional dyspepsiain 2026-06-10 anticipated 30 Complete https://irct.ir/trial/90009 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization method: Simple randomization. Randomization unit: Individual. Stratification factors: None. Randomization tool: Random Allocation Software. Method of generating random sequence: The random sequence will be generated by a person outside the research team (research assistant) using Random Allocation Software. The software will generate a random list of 30 numbers consisting of 1 and 2 (corresponding to the experimental group and the control group, respectively) with an equal allocation ratio (1:1). This generated random sequence will be the basis for assigning participants to the groups. Allocation concealment: All allocation procedures will be performed by the research assistant who will have no role in the subsequent intervention and assessment phases. The final allocation results will be recorded and stored in sealed envelopes to ensure allocation concealment. Participants will be assigned to one of the two groups based on the generated random sequence in order of entry into the study. N/A Functional Dyspepsia. Intervention 1: Intervention group: Mindfulness-Based Cognitive Therapy (MBCT) was first developed by Segal, Williams, and Teasdale (2002). In this study, the intervention will be delivered based on the standard 8-session MBCT protocol, with each session lasting 90 minutes and held weekly. The sessions include training in mindfulness practices (focusing on breath, body scan, awareness of thoughts and feelings), reviewing negative thought patterns, practicing acceptance and self-compassion, and teaching emotion regulation skills. This intervention will be delivered in a group format over 8 weeks (one session per week). Intervention 2: Control group: Without receiving any intervention during the study (waiting list group). Yes - There is a plan to make this available What will be shared: All data can be shared after the participants have been de-identified. When: Access begins 6 months after final publication. To whom: Families, stakeholders, and officials of counseling and psychotherapy centers, hospitals, and other mental health professionals can have access to the general results of this study. Raw and identifiable data of participants are confidential and are only available to the research team. Conditions: Data may only be used for research, educational, and therapeutic development purposes related to Mindfulness-Based Cognitive Therapy (MBCT). Conditions of use: Approval of the research proposal by the principal investigator, anonymity of data, confidentiality, prohibition of commercial use, citation of the source, and no transfer to third parties. Conditions for submitting a request: Submit a written request along with a research proposal to the principal investigator's email, provide a written confidentiality commitment, and obtain ethics committee approval if required. Where to obtain: Send an email to: poustizades@gmail.com How to obtain: The applicant first submits a written request along with a research proposal to the principal investigator's email address (poustizades@gmail.com). After receiving the request, the research team will review the proposal for scientific merit and alignment with the objectives of the original study within a maximum of two weeks. If approved, the applicant must provide a written commitment to adhere to confidentiality regulations (data anonymization and non-disclosure of participant identities) and to refrain from commercial use of the data. Upon receipt of the commitment letter, the anonymized data will be made available to the applicant within a maximum of one week via email or a download link. If the request is rejected, the reason will be communicated to the applicant. The entire process will take a maximum of 3 weeks. Comments:
public Sajjad Pousti Zadeh Dezfoli.
346, Between Motahari and Khayyam, Mohtasham Kashani Street, Dezful, Iran.
Dezfol Iran (Islamic Republic of) 6461855993 +98 991 604 0346 poustizades@gmail.com Islamic Azad University scientific Marzieh Talebzadeh Shoushtari.
Islamic Azad University, Ahvaz Branch, Farhangshahr, Golestan Highway, Ahvaz, Iran.
Ahvaz Iran (Islamic Republic of) 37333-61349 +98 61 3334 8420 talebzadehmarzieh@gmail.com Islamic Azad University Iran (Islamic Republic of) Definitive diagnosis of functional dyspepsia by a gastroenterologist based on Rome IV criteria Age between 20 and 55 years Having at least a high school diploma Residing in Ahvaz city during the study period Signing the informed consent form to participate in the study 20 years 55 years Both Use of psychiatric medications Concurrent use of other treatment methods Refusal of participants to complete the questionnaires Absence from two or more treatment sessions Submission of incomplete questionnaires Occurrence of stressful events such as divorce or death of relatives or close friends in the past three months K30 Functional dyspepsia Treatment - Other Placebo Intervention group: Mindfulness-Based Cognitive Therapy (MBCT) was first developed by Segal, Williams, and Teasdale (2002). In this study, the intervention will be delivered based on the standard 8-session MBCT protocol, with each session lasting 90 minutes and held weekly. The sessions include training in mindfulness practices (focusing on breath, body scan, awareness of thoughts and feelings), reviewing negative thought patterns, practicing acceptance and self-compassion, and teaching emotion regulation skills. This intervention will be delivered in a group format over 8 weeks (one session per week). Control group: Without receiving any intervention during the study (waiting list group) Anxiety. Timepoint: It is measured at two time points: 1- Pretest (one week before the start of the intervention) 2- Posttest (one week after the completion of the last intervention session). Method of measurement: Using the Beck Anxiety Inventory. Irrational Beliefs. Timepoint: It is measured at two time points: 1- Pretest (one week before the start of the intervention) 2- Posttest (one week after the completion of the last intervention session). Method of measurement: Using the Jones Irrational Beliefs Questionnaire. Quality of Life. Timepoint: It is measured at two time points: 1- Pretest (one week before the start of the intervention) 2- Posttest (one week after the completion of the last intervention session). Method of measurement: Using the World Health Organization Quality of Life Questionnaire (WHOQOL). Self-Compassion. Timepoint: It is measured at two time points: 1- Pretest (one week before the start of the intervention) 2- Posttest (one week after the completion of the last intervention session). Method of measurement: Using the Neff Self-Compassion Scale. Islamic Azad University, Ahvaz Branch. Approved 2026-01-07 Research Ethics Committees of Islamic Azad University - Ahvaz Branch Islamic Azad University of Ahvaz, Farhangshahr, Golestan Blvd., Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)