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IRCT20220725055553N1 IRCT 2026-02-17 Esfahan University of Medical Sciences he Effect of Mindfulness-Based Cognitive Behavioral Therapy on Emotion and Cognitive Function in Patients with Mood Disorders The effectiveness of cognitive behavioral therapy based on mindfulness on emotional regulation, metacognitive ability, and cognitive flexibility in patients with mood disorders . 2026-02-20 anticipated 68 Complete https://irct.ir/trial/88782 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, simple individual-level randomization will be used. After eligibility is confirmed and the baseline assessment is completed, each participant will be randomly assigned to either the intervention or control group. The random sequence will be generated by an independent statistician using SPSS software, and the allocation list will be kept confidential by the statistician. For allocation concealment, a central allocation method will be used: once the participant’s baseline information is fully recorded, the implementing researcher will contact the statistician to obtain the assigned group. Therefore, the implementer will have no prior knowledge of the participant’s group. Additionally, the person collecting the questionnaires will be blinded to the participants’ group assignments, and the data will be provided to the statistical analyst in a coded form (Groups 1 and 2) to ensure analyses are conducted without knowledge of the intervention type. The codes will only be revealed after the analysis is completed, Blinding description: To ensure impartiality, data analysis will be conducted in a single-blind manner. Raw data, after group coding with neutral labels (e.g., Group 1 and Group 2) and without disclosure of the type of intervention, will be provided to the analyst. The analyst will perform all statistical tests based solely on these codes and will remain unaware of the allocation of each group to the intervention or control until the initial analysis is completed. This process prevents bias in the analysis. N/A Bipolar affective disorder. Intervention 1: The intervention for the experimental group consists of a structured psychological protocol that combines cognitive-behavioral therapy (CBT) and mindfulness exercises (Mindfulness-Based Cognitive Therapy, MBCT). The primary goal of this intervention is to help patients with mood disorders (depression or bipolar disorder) increase awareness of their present-moment thoughts and feelings without judgment or automatic reactions. The intervention is delivered in the form of 8 in-person group sessions, each lasting 45 minutes, following the standard MBCT protocol, with sessions held three times per week. The total duration of the intervention is approximately three weeks. Sessions are led by a clinical psychologist trained in MBCT and include theoretical instruction, practical exercises, group discussions, and homework assignments. The session content includes the following:• Introduction to the concept of mindfulness and its importance in mood and emotion regulation• Body scan exercises and breathing practices• Identifying and observing thoughts and feelings as transient phenomena• Mindfulness practice in daily activities• Developing a non-judgmental attitude and acceptance without automatic reaction special equipment is required for the intervention other than a group therapy room, chairs, and the ability to play audio files (for some guided meditations). It should be noted that all participants are simultaneously receiving routine psychiatric care at the hospital, and the MBCT intervention is provided as an adjunctive therapy. Intervention 2: Control Group: Participants in this group do not receive any structured mindfulness-based cognitive-behavioral therapy sessions. Their intervention consists of standard routine psychiatric care provided by the hospital. This care includes regular follow-up by the treating psychiatrist for medication management, administration of prescribed psychiatric medications (with names, doses, and frequency according to the physician’s prescription), and routine nursing and environmental care on the ward. No educational programs, structured group therapy sessions, or other specific psychological interventions will be provided to this group during the study period. Like other hospitalized patients, members of this group receive only medical supervision and treatment. Yes - There is a plan to make this available What will be shared: Key data include: scores from the Cognitive Emotion Regulation Questionnaire (CERQ), metacognitive ability (Wells Questionnaire), cognitive flexibility (Dennis & Vanderwal), and baseline/demographic data such as age, sex, marital status, and hospitalization history. When: The access to de-identified participant data and related documents will begin **6 months after the publication of the study results** and will remain available for **5 years**. To whom: Academic Researchers Conditions: The de-identified participant data and related documents may be used only for scientific research purposes and secondary analyses related to the study topic. Requests for access to the data must be submitted by independent researchers with a clear research proposal and, upon approval by the ethics committee or the responsible research team, the data will be provided to the requester. Any publication of secondary results must cite the original study, and commercial use of the data is not permitted. Additionally, the requester is required to maintain data confidentiality and must refrain from any attempt to identify study participants. Where to obtain: Fatemeh Lohrasebi Flohrasebi@nm.mui.ac.ir How to obtain: After submitting a request for access to the data and documents along with a research proposal, the request will be reviewed by the study team and the ethics committee. Once approved, the de-identified data and documents will be provided to the requester through a secure method. This process typically takes 4 to 8 weeks. Comments:
public Fatemeh Lohrasebi Nejad
Hezar jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7607 Flohrasebi@nm.mui.ac.ir Esfahan University of Medical Sciences scientific Fatemeh Lohrasebi Nejad
Hezar jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7607 Flohrasebi@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Minimum literacy (ability to read and write)... Diagnosis of a mood disorder confirmed by a psychiatrist Hospitalization at Farabi Hospital Age range between 20 and 50 years. Written informed consent to participate in the study 20 years 50 years Both Severe mental disorders (as diagnosed by a psychiatrist) impeding participation in patient education sessions. history of substance abuse. F31 Bipolar disorder Lifestyle Other The intervention for the experimental group consists of a structured psychological protocol that combines cognitive-behavioral therapy (CBT) and mindfulness exercises (Mindfulness-Based Cognitive Therapy, MBCT). The primary goal of this intervention is to help patients with mood disorders (depression or bipolar disorder) increase awareness of their present-moment thoughts and feelings without judgment or automatic reactions. The intervention is delivered in the form of 8 in-person group sessions, each lasting 45 minutes, following the standard MBCT protocol, with sessions held three times per week. The total duration of the intervention is approximately three weeks. Sessions are led by a clinical psychologist trained in MBCT and include theoretical instruction, practical exercises, group discussions, and homework assignments. The session content includes the following:• Introduction to the concept of mindfulness and its importance in mood and emotion regulation• Body scan exercises and breathing practices• Identifying and observing thoughts and feelings as transient phenomena• Mindfulness practice in daily activities• Developing a non-judgmental attitude and acceptance without automatic reaction special equipment is required for the intervention other than a group therapy room, chairs, and the ability to play audio files (for some guided meditations). It should be noted that all participants are simultaneously receiving routine psychiatric care at the hospital, and the MBCT intervention is provided as an adjunctive therapy. Control Group: Participants in this group do not receive any structured mindfulness-based cognitive-behavioral therapy sessions. Their intervention consists of standard routine psychiatric care provided by the hospital. This care includes regular follow-up by the treating psychiatrist for medication management, administration of prescribed psychiatric medications (with names, doses, and frequency according to the physician’s prescription), and routine nursing and environmental care on the ward. No educational programs, structured group therapy sessions, or other specific psychological interventions will be provided to this group during the study period. Like other hospitalized patients, members of this group receive only medical supervision and treatment. Emotion regulation refers to an individual’s ability to recognize, manage, and control their emotions in a way that responses are appropriate to the context, goals, and social situations. This skill includes identifying emotions, modulating their intensity and duration, and selecting suitable strategies to cope with negative emotions or enhance positive ones. Emotion regulation plays a key role in mental health, decision-making, cognitive flexibility, and interpersonal relationships. Timepoint: pre and post intervention. Method of measurement: Gross & John’s Cognitive Emotion Regulation Questionnaire. Metacognitive ability refers to an individual’s skill in awareness, monitoring, and control of their own cognitive processes. This ability includes recognizing one’s thoughts and beliefs, understanding cognitive strengths and limitations, and managing strategies for problem-solving and decision-making. Metacognition plays a key role in learning, cognitive flexibility, self-regulation, and mental health enhancement. Timepoint: pre and post intervention. Method of measurement: Wells’ Metacognitions Questionnaire. Cognitive flexibility refers to an individual’s ability to adapt their thoughts, attitudes, and behaviors according to new or unexpected situations. This skill includes the capacity to view problems from different perspectives, select alternative strategies, and adjust to environmental changes, playing a key role in problem-solving, decision-making, and stress management. Timepoint: pre and post intervention. Method of measurement: Dennis & Vander Wal’s Cognitive Flexibility Scale. Esfahan University of Medical Sciences Approved 2026-01-20 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib Street, Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)