The Effectiveness of Mindfulness-Based Cognitive Therapy on Anxiety,Irrational Beliefs, quality of life and Self- compassion in patients with functional dyspepsiain

Determining the effectiveness of mindfulness-based cognitive therapy on anxiety, irrational beliefs, quality of life, and self-compassion in patients with functional dyspepsia.

Clinical trial with control group, parallel, randomized, unblinded, single-phase, on 30 patients (15 in experimental group, 15 in control group). Simple randomization using Random Allocation Software and allocation concealment using sealed envelopes.

Quasi-experimental study with pretest-posttest and control group. Sample: 30 patients with functional dyspepsia in Ahvaz (15 experimental, 15 control), selected purposively and randomly assigned. Experimental group receives 8 weekly 90-minute MBCT sessions; control group receives no intervention. No blinding.

**Inclusion Criteria:** Definitive diagnosis of functional dyspepsia based on Rome IV criteria, age 20 to 55 years, minimum high school diploma, residence in Ahvaz city, signed informed consent. **Exclusion Criteria:** Use of psychiatric medications, concurrent use of other treatment methods, refusal to complete questionnaires, absence of two or more sessions, incomplete questionnaires, occurrence of stressful events in the past three months (divorce, death of close relatives or close friends).

**Experimental Group:** 8 sessions of 90-minute group MBCT (once weekly for 8 weeks) based on the protocol by Segal et al. (2002). Content: mindfulness, body focus, identifying negative thoughts, emotional acceptance, mind-body connection, self-compassion, consolidation of changes, and summary. **Control Group:** No intervention during the study (waiting list). Treatment offered after study completion upon request.

Anxiety; irrational beliefs; quality of life; self-compassion.

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.

All data can be shared after the participants have been de-identified.

Access begins 6 months after final publication.

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.

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.

Send an email to: poustizades@gmail.com

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.