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IRCT20251129068145N10 IRCT 2026-11-08 Islamic Azad University, Najafabad Branch The Effectiveness of Body-Oriented Mentalization-Based Therapy on Quality of Life, Worry, Body Awareness, and Psychological Distress in Patients with Asthma The Effectiveness of Body-Oriented Mentalization-Based Therapy on Quality of Life, Worry, Body Awareness, and Psychological Distress in Patients with Asthma 2026-11-22 anticipated 36 Pending https://irct.ir/trial/94591 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will initially be recruited using convenience sampling based on the study’s eligibility criteria. After obtaining informed consent and completing the baseline assessments, eligible participants will be randomly allocated to either the experimental group or the control group in a 1:1 ratio. The random allocation sequence will be generated using computer-based random number generation software to ensure an unpredictable assignment process. Each participant will be assigned a unique study identification number, and group allocation will be determined according to the pre-generated randomization sequence. This procedure will help minimize selection bias and ensure an unbiased allocation of participants to the study groups. N/A Asthma. Intervention 1: Intervention group: Participants in the intervention group will take part in a 12-session body-oriented mentalization-based educational and therapeutic program. The sessions will focus on developing skills in bodily awareness, mindfulness, emotion recognition and regulation, identifying and understanding the window of tolerance, body-oriented mentalization, recognizing attachment patterns and interpersonal interaction styles, establishing personal boundaries, engaging in committed action, and effectively utilizing social support systems. Each session will include experiential exercises and homework assignments tailored to its specific content. Intervention 2: Control group: Participants in the control group will receive no intervention during the study period and will continue their usual care. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Dr. Gholamreza Talebi
Islamic Azad University Najafabad Branch, Daneshgah Blvd., Najafabad, Isfahan Province.
Najafabad Iran (Islamic Republic of) 8135866531 +98 31 3237 1841 rezatalebi@iau.ac.ir Islamic Azad University, Najafabad Branch scientific Dr. Gholamreza Talebi
Islamic Azad University Najafabad Branch, Daneshgah Blvd., Najafabad, Isfahan Province.
Najafabad Iran (Islamic Republic of) 8135866531 +98 31 3237 1841 rezatalebi@iau.ac.ir Islamic Azad University, Najafabad Branch Iran (Islamic Republic of) Confirmed diagnosis of asthma. Age over 18. Physical ability to attend the scheduled sessions. Willingness to participate in the study and provide written informed consent. Basic literacy (ability to read and write). Not receiving any other psychological treatment during the study. 18 years no limit Both Occurrence of a significant medical event during the study, such as the development of another chronic physical illness. History of physical conditions requiring specific medications or dietary regimens. J45 Asthma Treatment - Other Treatment - Other Intervention group: Participants in the intervention group will take part in a 12-session body-oriented mentalization-based educational and therapeutic program. The sessions will focus on developing skills in bodily awareness, mindfulness, emotion recognition and regulation, identifying and understanding the window of tolerance, body-oriented mentalization, recognizing attachment patterns and interpersonal interaction styles, establishing personal boundaries, engaging in committed action, and effectively utilizing social support systems. Each session will include experiential exercises and homework assignments tailored to its specific content. Control group: Participants in the control group will receive no intervention during the study period and will continue their usual care. Quality of Life. Timepoint: Quality of life will be assessed at baseline (pre-intervention) and immediately after completion of the 12-session intervention (post-intervention). Method of measurement: Quality of life will be assessed using the 26-item World Health Organization Quality of Life Questionnaire (WHOQOL-BREF). The questionnaire evaluates four domains: physical health, psychological health, social relationships, and environmental health. Responses are rated on a 5-point Likert scale. Items 3, 4, and 26 are reverse-scored. Domain scores are calculated according to the standardized scoring guidelines, with higher scores indicating better quality of life. Worry. Timepoint: Worry will be assessed at baseline (pre-intervention) and immediately after completion of the 12-session intervention (post-intervention). Method of measurement: Worry will be assessed using the 16-item Penn State Worry Questionnaire (PSWQ). This self-report questionnaire measures the severity, frequency, and uncontrollability of excessive and persistent worry. Items are rated on a 5-point Likert scale, ranging from 1 (not at all typical of me) to 5 (very typical of me). Five items are reverse-scored, and total scores range from 16 to 80, with higher scores indicating greater levels of worry. Body Awareness. Timepoint: Body awareness will be assessed at baseline (pre-intervention) and immediately after completion of the 12-session intervention (post-intervention). Method of measurement: Body awareness will be assessed using the 18-item Body Awareness Questionnaire (BAQ), developed by Shields et al. (1989). The questionnaire measures individuals' awareness of normal bodily processes, changes in bodily sensations, and physiological responses. Items are rated on a 9-point Likert scale, ranging from 1 (does not apply to me at all) to 9 (applies to me completely). The total score is calculated according to the instrument's scoring guidelines, with higher scores indicating greater body awareness. Psychological distress is defined as a general negative emotional state associated with symptoms of depression, anxiety, and stress. Timepoint: Depression, anxiety, and stress will be assessed at baseline (pre-intervention) and immediately after completion of the 12-session intervention (post-intervention). Method of measurement: Depression, anxiety, and stress will be assessed using the 21-item Depression, Anxiety, and Stress Scale (DASS-21), developed by Lovibond and Lovibond (1995). The questionnaire consists of three 7-item subscales measuring depression, anxiety, and stress. Items are rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Subscale scores are calculated by summing the relevant items and multiplying the results by two, with higher scores indicating greater symptom severity. Islamic Azad University, Najafabad Branch Approved 2026-10-22 Research Ethics Committee of Islamic Azad University- Najafaba Branch Islamic Azad University, Najafabad Branch, University Boulevard, Najafabad, Isfahan, Iran. Isfahan Isfehan Iran (Islamic Republic of)