Volume 23, Issue 3 (7-2026)                   | Back to browse issues page

Ethics code: IR.ARAKMU.REC.1402.199


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Hosseini M, Shamsikhani S, Rafiei F, jadidi A. The Effect of Self-Regulation Education on Psychosocial Outcomes in Women with Multiple Sclerosis: A Randomized Controlled Trial Protocol. Mod Care J 2026; 23 (3) :12-19
URL: http://mcj.bums.ac.ir/article-1-629-en.html
1- MSc.Shazand School of Nursing, Arak University of Medical Sciences, Arak, Iran
2- Ph.D in Nursing, Shazand School of Nursing, Arak University of Medical Sciences, Arak, Iran , shamsikhani@arakmu.ac.ir
3- Department of Biostatistics ,School of Medicine,Arak University of Medical Sciences, Arak, Iran
4- Department of Nursing, School of Nursing, Arak University of Medical Sciences, Arak, Iran
Abstract:   (110 Views)
Introduction: Multiple sclerosis (MS) is a progressive neurological disorder that imposes significant physical, functional, and economic burdens, severely impacting patients’ quality of life. Given the multifaceted psychological and physical challenges associated with this condition, there is a critical need for structured interventions. This study will implement an intervention based on the Leventhal Self-Regulation Model (SRM), utilizing a three-stage framework of representation, coping, and appraisal to address both physical and emotional dimensions.
Objectives: This study aimed to assist patients in gaining a deeper understanding of their condition, thereby enhancing their capacity to adapt to the complex emotional and psychological distress inherent in living with MS.
Methods: This randomized controlled trial will be conducted on 64 MS patients who are selected based on inclusion criteria and classified into two groups: control and intervention, using block randomization. Individuals in the intervention group will receive educational content designed according to the steps of Leventhal's SRM, while the control group receive no intervention. The educational content for the intervention group is designed in a multimedia format, using the trial and free version of Storyline 360 software. All sessions will be conducted virtually, with one to two in-person sessions (group or individual) as needed and requested by participants. The virtual training program includes synchronous (online) and asynchronous (offline) training.
Conclusions: This article will be the first randomized trial to focus on both physical and emotional aspects of Leventhal’s SRM in women with MS. The study aims to determine the efficacy of this intervention in improving illness perception and reducing the severity of psychological symptoms, including depression, anxiety, and stress. This trial is registered with the Iranian Clinical Trials Registry (IRCT) under the code: IRCT20220703055351N3
Full-Text [PDF 493 kb]   (34 Downloads)    
Article Types: Research Article | Subject: Community and Health Education
Received: 2026/05/9 | Accepted: 2026/08/18 | Published: 2026/08/26

References
1. 1. Kobelt G, Thompson A, Berg J, Gannedahl M, Eriksson J. MSCOI Study Group; European Multiple Sclerosis Platform. New insights into the burden and costs of multiple sclerosis in Europe. Mult Scler. 2017 Jul;23(8):1123-1136. [PMID: 28273775]; [PMCID: PMC5476197]. [DOI:10.1177/1352458517694432]
2. Browne P, Chandraratna D, Angood C, Tremlett H, Baker C, Taylor BV, et al. Atlas of multiple sclerosis 2013: a growing global problem with widespread inequity. Neurology. 2014;83(11):1022-4. [DOI:10.1212/WNL.0000000000000768]
3. Coyle PK. What Can We Learn from Sex Differences in MS? J Pers Med. 2021;11(10):1006. [PMID: 34683148]; [PMCID: PMC8537319]. [DOI:10.3390/jpm11101006]
4. Salehi Z, Almasi-Hashiani A, Sahraian MA, Ashtari F, Baghbanian SM, Razazian N, et al. Epidemiology of familial multiple sclerosis in Iran: a national registry-based study. BMC Neurol. 2022;22(1):76. [PMID: 35248009]; [PMCID: PMC8897924]. [DOI:10.1186/s12883-022-02609-1]
5. Magyari M, Sorensen PS. Comorbidity in Multiple Sclerosis. Front Neurol. 2020; 11:851. [PMID: 32973654]; [PMCID: PMC7473304]. [DOI:10.3389/fneur.2020.00851]
6. Marrie RA, Fisk JD, Yu BN, Leung S, Elliott L, Caetano P, et al. Mental comorbidity and multiple sclerosis: validating administrative data to support population-based surveillance. BMC Neurol. 2013; 13:16. [PMID: 23388102]; [PMCID: PMC3599013]. [DOI: 10.1186/1471-2377-13-16] [DOI:10.1186/1471-2377-13-16]
7. Karimi S, Andayeshgar B, Khatony A. Prevalence of anxiety, depression, and stress in patients with multiple sclerosis in Kermanshah-Iran: a cross-sectional study. BMC Psychiatry. 2020;20(1):166. [PMID: 32295564]; [PMCID: PMC7161227]. [DOI:10.1186/s12888-020-02579-z]
8. Sawyer AT, Harris SL, Koenig HG. Illness perception and high readmission health outcomes. Health psychology open. 2019;6(1):2055102919844504. [PMID: 31041109]; [PMCID: PMC6482662]. [DOI:10.1177/2055102919844504]
9. Obiwuru O, Joseph S, Liu L, Palomeque A, Tarlow L, Langer-Gould AM, et al. Perceptions of multiple sclerosis in Hispanic Americans: need for targeted messaging. Int J MS Care.2017;19(3):131-9. [PMID: 28603461]; [PMCID: PMC5460866]. [DOI:10.7224/1537-2073.2015-081]
10. Christensen AJ, Wiebe JS, Edwards DL, Michels JD, Lawton WJ. Body consciousness, illness-related impairment, and patient adherence in hemodialysis. J Consult Clin Psychol.1996;64(1):147-52. [PMID: 8907094]. [DOI:10.1037//0022-006X.64.1.147]
11. Leventhal H, Diefenbach M, Leventhal EA. Illness cognition: Using common sense to understand treatment adherence and affect cognition interactions. Cogn Ther Res. 1992;16(2):143-63. [DOI:10.1007/BF01173486]
12. Leventhal H, Brissette I, Leventhal EA. The common-sense model of self-regulation of health and illness. In: Cameron LD, Leventhal H, eds. The self-regulation of health and illness behavior. London: Routledge; 2003. [Link]
13. Groarke A, Curtis R, Coughlan R, Gsel A. The role of perceived and actual disease status in adjustment to rheumatoid arthritis. Rheumatology (Oxford). 2004;43(9):1142-9. [PMID: 15199221]. [DOI:10.1093/rheumatology/keh262]
14. Rahimi Z, Baliani S, Zadgasem Z. Investigating the relationship between illness perception and quality of life in hemodialysis patients. IRANIAN JOURNAL OF CRITICAL CARE NURSING (IJCCN). 2012;5(3):151-158. [Persian]. [URL: https://sid.ir/paper/585982/en ]
15. Taheri-Kharameh Z, Hazavehei SMM, Ramezani T, Vahedi A, Khoshro M, Sharififard F. The assessment of illness perception and adherence to therapeutic regimens among patients with hypertension. J Educ Community Health. 2016;3(2):9-15. [Persian]. [DOI:10.21859/jech-03022]
16. Rakhshan M, Hassani P, Ashktorab T, Majd HA. The nature and course of illness perception following cardiac pacemaker implantation: a self‐regulatory approach. Int J Nurs Pract. 2013;19(3):318-25. [PMID: 23730864]. [DOI:10.1111/ijn.12073]
17. Saranjam F, Afrasiabifar A, Alamdari A, Hosseini N. Effect of Leventhal's self-regulatory intervention on the hypertensive patients' illness perception and lifestyle: a randomized controlled trial. BMC Cardiovasc Disord. 2023;23(1):50. [PMID: 36703112]; [PMCID: PMC10127530]. [DOI:10.1186/s12872-023-03049-6]
18. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-7. [PMID: 23295957]; [PMCID: PMC5114123]. [DOI:10.7326/0003-4819-158-3-201302050-00583]
19. Al Shakarchi J. How to write a research study protocol. J Surg Protoc Res Methodol. 2022;2022(1): snab008. [DOI:10.1093/jsprm/snab008]
20. Khodaparast S, Soleimani MA, Bahrami N, Mafi M. Effect of Leventhal's Self-Regulatory Model on Illness Perception in Women with Gestational Diabetes: A Randomized Controlled Clinical Trial. J Mazandaran Univ Med Sci. 2019; 29 (177):111-123. [Persian] [URL: http://jmums.mazums.ac.ir/article-1-12957-en.html]
21. Sealed Envelope Ltd. Create a blocked randomisation list [Internet]. 2024 [cited 2026]. Available from: [Link]
22. Lovibond PF, Lovibond SH. The structure of negative emotional states: Comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995;33(3):335-43. [PMID: 7726811]. [DOI:10.1016/0005-7967(94)00075-U]
23. Sahebi A, Asghari MJ, Salari R. Validation of depression anxiety and stress scale (DASS-21) for an Iranian population. J. Iran. Psychol. 2005;1(4). [Link]
24. Kakemam E, Navvabi E, Albelbeisi AH, Saeedikia F, Rouhi A, Majidi S. Psychometric properties of the Persian version of Depression Anxiety Stress Scale-21 Items (DASS-21) in a sample of health professionals: a cross-sectional study. BMC Health Serv Res. 2022;22(1):111. [PMID: 35078477]; [PMCID: PMC8789546]. [DOI:10.1186/s12913-022-07514-4]
25. Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006;60(6):631-7. [PMID: 16731240]. [DOI:10.1016/j.jpsychores.2005.10.020]
26. Masaeli N, Bagherian R, Kheirabadi G, Khedri A, Mahaki B. Psychometric Properties of the Persian Version of the Brief Illness Perception Questionnaire in Chronic Diseases. J Res Rehabil Sci. 2018;14(6):332-7. [DOI: 10.22122/jrrs. v14i6.3266 ]
27. Karampour S, Masoudi R, Raeisi H, Etemadifar S, Bayati A. The effect of self-regulatory program based on Leventhal's model on the illness perception and resilience of people with multiple sclerosis. J Educ Health Promot. 2024; 13:340. [PMID: 39679025]; [PMCID: PMC11639432]. [DOI:10.4103/jehp.jehp_1294_23]

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