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IRCT20251101067851N1 IRCT 2026-03-15 Islamic Azad University A Comparison of the Effect of Behavioral Therapy Packages on Mindfulness in Patients with Obesity. A Comparison of the Effectiveness of Dialectical Behavior Therapy and Mindfulness-Based Cognitive Therapy Packages on Weight-Related Self-Efficacy, Fear of Negative Evaluation, and Psychological Distress in Patients with Obesity. 2026-03-01 anticipated 45 Complete https://irct.ir/trial/87674 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sample of the present study will be selected using purposive sampling. Specifically, from among individuals with obesity who will refer to selected medical centers in Tehran during the study period and who meet the study's inclusion and exclusion criteria, 45 individuals will be selected. The random sequence will be generated using Random Allocation Software by someone outside the research team (a research assistant). The method used will be simple randomization with equal allocation ratio (1:1:1) for the three groups. That is, the software will generate a random list of 45 numbers consisting of 1, 2, and 3 (corresponding to Experimental Group 1, Experimental Group 2, and Control Group, respectively). The process of randomly allocating these 45 participants into three groups of 15 will be carried out as follows: After obtaining informed consent and completing the pre-test, each participant will be assigned a unique identification code. Then, based on the random sequence generated by the software, participants will be placed into one of the three groups in the order they enter the study (from code 1 to 45). All allocation steps will be performed by a research assistant who will not be involved in the subsequent intervention and assessment stages, and the final result will be recorded and stored in sealed envelopes to maintain the principle of allocation concealment. Due to the psychological nature of the interventions, blinding the interventionist and participants will not be possible; however, to reduce measurement bias, the primary outcome assessor (the person collecting the post-test data) will be kept unaware of each participant's group assignment (blinded assessment). N/A Patients with obesity. Intervention 1: First Intervention Group (Dialectical Behavior Therapy): The content of this intervention was extracted using the research synthesis method based on dialectical behavior therapy, and its validity was confirmed by expert professors. This intervention was delivered to participants in eight 90-minute group sessions over 8 weeks (one session per week). Detailed session content: Session 1 (Introduction and Conceptualization): Introduction, motivation building and case conceptualization, creating a safe space and introducing group rules, teaching the psychological model of obesity; Session 2 (Emotional Awareness and Identifying Real Needs): Types of hunger, increasing emotional awareness, and identifying real needs; Session 3 (Teaching the Inner Critic, Cultivating Self-Acceptance): Introducing and identifying mental wandering; Session 4 (Controlling Cravings and Temptations); Session 5 (Teaching Inner and Outer Wisdom); Session 6 (Breathing and Mindful Meditation Exercises); Session 7 (Integrating the Mind-Body-Emotion Connection); Session 8 (Session Summary and Post-test Administration). Intervention 2: Second Intervention Group: Mindfulness-Based Cognitive Therapy: The content of this intervention was extracted using the research synthesis method based on mindfulness-based cognitive therapy for binge eating and obesity, and its validity was confirmed by expert professors. This intervention was delivered to participants in eight 90-minute group sessions over 8 weeks (one session per week).Detailed session content: Session 1 (Introduction and Conceptualization): Establishing a therapeutic relationship, presenting the dialectical framework (acceptance vs. change), defining weight-related problems in terms of difficulty managing emotions and behaviors, and setting realistic personal goals. Session 2 (Distress Tolerance and Flexibility): Teaching survival skills for distressing situations without resorting to binge eating. Session 3 (Levels of Mind): Increasing awareness of different states of mind and their impact on decision-making and eating behaviors. Session 4 (Emotion Management): Identifying, naming, and modulating problematic emotions instead of suppressing them or acting impulsively. Session 5 (Nutrition and Body Awareness): Providing scientifically-based nutritional information (with a non-restrictive, acceptance-based approach), without imposing strict diets, and fostering a healthy relationship with the body and food. Session 6 (Chain Analysis of Events Contributing to Binge Eating): Precise and personalized identification of triggers, thoughts, emotions, and consequences related to binge eating. Session 7 (Managing Unhealthy Behaviors and Thought Patterns): Modifying dysfunctional beliefs about food, body, and self, reducing weight-related avoidance behaviors, and interpersonal skills training. Session 8 (Session Summary, Mindful Attention, Post-test): Reviewing and integrating skills, assessing progress, and developing a plan to maintain achievements, cope with future challenges, and prevent relapse. Intervention 3: Control group: does not receive any intervention. 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: Eligible applicants include researchers, healthcare professionals (e.g., physicians, psychologists, nutritionists), and postgraduate students (Master’s or Doctoral level) in fields such as psychology, public health, medicine, and related disciplines. Submission of a data access request is permitted following verification of academic credentials and purpose by the Principal Investigator. Conditions: The data and documentation from this study are available for research, educational, and therapeutic development purposes. Access is granted subject to the approval of a formal research proposal by the Principal Investigator and strict adherence to confidentiality protocols, including full data anonymization. Where to obtain: Correspondence email: dr.s.saeidi62@gmail.com How to obtain: Applicants for data who are currently enrolled in a graduate program in one of the fields of psychology, health psychology, therapists and psychology specialists, nutritionists, or physicians can obtain the data file after submitting their documents to the researcher's email address. Comments:
public Sahar Saeigiasl
Unit 18, No. 12, 20th Western Alley, Allameh North Street, Sarv Sharghi Street, Kaj Square, Sa'adat Abad
Tehran Iran (Islamic Republic of) 1997977449 +98 21 2213 4096 dr.s.saeidi62@gmail.com Islamic Azad University scientific Sahar Saeidiasl
Unit 18, No. 12, 20th Western Alley, Allameh North Street, Sarv Sharghi Street, Kaj Square, Sa'adat Abad
Tehran Iran (Islamic Republic of) 1997977449 +98 21 2213 4096 dr.s.saeidi62@gmail.com Islamic Azad University Iran (Islamic Republic of) Having literacy skills for reading and writing Willingness to participate in the study and complete the consent form to receive the therapeutic intervention Not taking any medication At least 2 years have passed since the diagnosis of obesity Body Mass Index (BMI) between 30 and 35 Age range between 18 and 45 years old 18 years 45 years Both Substance and alcohol abuse. Receiving psychological interventions during the past 6 months. Having chronic physical illnesses or psychological disorders. E66.9 Obesity, unspecified Treatment - Other Treatment - Other Placebo First Intervention Group (Dialectical Behavior Therapy): The content of this intervention was extracted using the research synthesis method based on dialectical behavior therapy, and its validity was confirmed by expert professors. This intervention was delivered to participants in eight 90-minute group sessions over 8 weeks (one session per week). Detailed session content: Session 1 (Introduction and Conceptualization): Introduction, motivation building and case conceptualization, creating a safe space and introducing group rules, teaching the psychological model of obesity; Session 2 (Emotional Awareness and Identifying Real Needs): Types of hunger, increasing emotional awareness, and identifying real needs; Session 3 (Teaching the Inner Critic, Cultivating Self-Acceptance): Introducing and identifying mental wandering; Session 4 (Controlling Cravings and Temptations); Session 5 (Teaching Inner and Outer Wisdom); Session 6 (Breathing and Mindful Meditation Exercises); Session 7 (Integrating the Mind-Body-Emotion Connection); Session 8 (Session Summary and Post-test Administration). Second Intervention Group: Mindfulness-Based Cognitive Therapy: The content of this intervention was extracted using the research synthesis method based on mindfulness-based cognitive therapy for binge eating and obesity, and its validity was confirmed by expert professors. This intervention was delivered to participants in eight 90-minute group sessions over 8 weeks (one session per week).Detailed session content: Session 1 (Introduction and Conceptualization): Establishing a therapeutic relationship, presenting the dialectical framework (acceptance vs. change), defining weight-related problems in terms of difficulty managing emotions and behaviors, and setting realistic personal goals. Session 2 (Distress Tolerance and Flexibility): Teaching survival skills for distressing situations without resorting to binge eating. Session 3 (Levels of Mind): Increasing awareness of different states of mind and their impact on decision-making and eating behaviors. Session 4 (Emotion Management): Identifying, naming, and modulating problematic emotions instead of suppressing them or acting impulsively. Session 5 (Nutrition and Body Awareness): Providing scientifically-based nutritional information (with a non-restrictive, acceptance-based approach), without imposing strict diets, and fostering a healthy relationship with the body and food. Session 6 (Chain Analysis of Events Contributing to Binge Eating): Precise and personalized identification of triggers, thoughts, emotions, and consequences related to binge eating. Session 7 (Managing Unhealthy Behaviors and Thought Patterns): Modifying dysfunctional beliefs about food, body, and self, reducing weight-related avoidance behaviors, and interpersonal skills training. Session 8 (Session Summary, Mindful Attention, Post-test): Reviewing and integrating skills, assessing progress, and developing a plan to maintain achievements, cope with future challenges, and prevent relapse. Control group: does not receive any intervention. Weight-related self-efficacy. Timepoint: Before the start of the intervention and at the end of the intervention sessions. Method of measurement: Weight Self-Efficacy Questionnaire (WSEQ). Fear of negative evaluation. Timepoint: Before the start of the intervention and at the end of the intervention sessions. Method of measurement: Brief Fear of Negative Evaluation Scale. Psychological distress. Timepoint: Before the start of the intervention and at the end of the intervention sessions. Method of measurement: Depression Anxiety Stress Scales. Islamic Azad University, Kish International Branch Approved 2025-09-06 The Research Ethics Committee of Islamic Azad University - Tehran North Branch 5th Floor, Shahid Fakhrizadeh Research and Laboratory Building, Islamic Azad University, Tehran North Branch, Vafadar Boulevard, Shahid Sadoughi Street, Hakimiyeh Exit, Shahid Babaei Highway (Westbound), Tehran, Iran Tehran Tehran Iran (Islamic Republic of)