The current study was conducted as a randomized educational trial involving women referred to the MS Association in Arak City in 2024. For this study, the Iranian Registry Clinical Trial code (IRCT) is IRCT20220703055351N3.

The inclusion criteria specified that participants must be women aged between 18 and 50, possess access to a smartphone, be literate, and demonstrate communication skills in reading, writing, speaking, and listening. Participants must have had at least one year since the initial onset of the disease. Additionally, their medical history should be free of any other neurological, mental, or autoimmune disorders, and they must not be experiencing any uncontrolled acute illnesses during their participation in the study. Furthermore, their condition should not have relapsed, and they must not be using any narcotic substances. Participants are required to achieve a maximum score of 5.5 on the expanded disability status scale and should not have undergone any training that aligns with the objectives of this research. Informed consent was obtained from all participants.

The exclusion criteria included reluctance to maintain collaboration, disease recurrence, hospitalization for illness or other reasons, or significant life changes such as relocation, unexpected illness, or pregnancy.

The sample size was determined based on information from previous studies (32). With α set at 5% and β at 0.1, the following formula was applied:

The initial calculation indicated that 29 participants were required in both the control and experimental groups. To account for potential sample loss (10%), this number was increased to 32 participants per group, resulting in a total sample size of 64. During the research, four individuals were excluded, leaving a total of 60 participants. A convenience sampling method was employed. The Sealedenvelope website was utilized to generate a block random allocation list (33). Randomization was concealed through centralized randomization. Following participant enrollment, the researcher informed participants via SMS and consulted with another researcher to determine the random allocation of participants (34).

This research introduced self-regulation training based on the Leventhal model. It comprised one in-person session for foundational knowledge, eight offline sessions for cognitive and emotional development, and two online group sessions for illness adaptation within one month. Virtual education included both synchronous (online) and asynchronous (offline) programs, with synchronous sessions held in groups and asynchronous sessions conducted individually.

The offline sessions incorporated multimedia elements, including podcasts, videos, and slides, which were uploaded to cloud storage (Dropbox). Links to each session were distributed via a Telegram group. The multimedia content addressed both the physical and emotional aspects of the disease. In collaboration with experts from various disciplines relevant to the disease’s dimensions, the materials were meticulously crafted based on articles, books, and expert insights (Table 1). The training was organized according to reliable scientific sources (1, 19, 30, 35–54).

The online group sessions were structured as peer groups to facilitate participant experience exchange. Participants were invited to engage in discussions with their peers and to create dynamic interactions with the researcher. Online sessions were conducted in a Telegram group.

The training was structured around the three stages of Leventhal’s self-regulation model: 1. Representation, 2. Coping, and 3. Appraisal (Figure 1). It was designed to encompass both cognitive and emotional dimensions.

In this study, data collection comprised two components: the demographic information form and the Depression Anxiety Stress Scale (DASS) questionnaire.

Data analysis was performed using SPSS version 26.0, employing both descriptive statistics (means, standard deviations, frequencies, and percentages) and inferential statistics, including chi-square and Fisher’s exact tests. The Kolmogorov–Smirnov test was employed to assess data normality, confirming that the data were normally distributed. Independent t-tests and the equivalent nonparametric Mann–Whitney tests were utilized to compare quantitative measures across groups. A repeated measures analysis of variance was conducted to evaluate changes over three time points, and the Bonferroni pairwise comparison test was applied to examine temporal changes.

In December 2023, the ethics committee of the Arak University of Medical Sciences approved this research, assigning it the reference number IR.ARAKMU.REC.1402.199. Throughout the study, the moderators adhered to ethical considerations, including informed consent, confidentiality, the right to withdraw, and compensation for any potential harm.

As presented in Table 4, the experimental group experienced a significant decrease in average anxiety scores following the intervention compared to pre-intervention levels (p < 0.05), but one month after the intervention, the average anxiety score increased significantly (p < 0.05). In the control group, there was no significant difference in average anxiety scores following the intervention (p > 0.05). Similar to the experimental group, the control group also exhibited a significant increase in anxiety levels one month after the intervention compared to post-intervention scores (p < 0.05).

The analysis revealed significant differences in average stress changes over time between the two groups. Both the experimental and control groups showed a significant decrease in average stress levels after the intervention and one-month post-intervention compared to pre-intervention levels (p < 0.05). However, in the experimental group, there was a significant increase in average stress levels one month after the intervention compared to post-intervention levels (p < 0.05).

In the experimental group, the average depression score decreased significantly after the intervention compared to pre-intervention levels (p < 0.05). At subsequent evaluation points, no significant changes were observed (p > 0.05). In the control group, there were no significant differences in average depression scores across the evaluation periods (p > 0.05).

The experimental group demonstrated a significant reduction in anxiety immediately after the intervention (p < 0.05). However, one month later, anxiety levels significantly increased (p < 0.05), indicating that the intervention’s effect was not maintained long-term. In contrast, the control group showed no significant change in anxiety levels, except for a significant increase one month after the intervention (p < 0.05). These results suggest that while the intervention produced initial efficacy, supplementary strategies may be necessary to sustain its benefits. Previous research has shown that psychological interventions based on the illness perception framework, including the Leventhal model, can effectively reduce anxiety (58, 59). Similarly, the intergroup comparison confirmed a significant intervention effect on anxiety reduction. Specifically, no significant difference was observed before the intervention (p > 0.05), but after the intervention and at the one-month follow-up, the experimental group presented significantly lower anxiety levels than did the control group (p < 0.05). These findings align with previous research demonstrating an inverse relationship between illness perception and anxiety levels (60).

The experimental group showed a significant decrease in depressive symptoms after the intervention (p < 0.05), and this improvement persisted at the one-month follow-up. In contrast, the control group showed an increasing trend in depressive symptoms over time, although this change was not statistically significant. Depression is a common concern among patients with MS (61) and is often associated with the unpredictability of the disease and uncertainty about prognosis (62). Given that the intervention enhanced both the cognitive and physical aspects of illness perception, it is plausible that it contributed to a better understanding of the disease course and, consequently, a reduction in depressive symptoms. These results are consistent with previous research that emphasized the role of illness perception interventions in reducing depression in populations with chronic illnesses (63, 64).

Both groups presented a significant reduction in stress after the intervention (p < 0.05), but this decrease was not sustained over time in the experimental group. Interestingly, stress levels also decreased in the control group, suggesting that factors such as participant expectations or the study design might have influenced these outcomes. Previous research underscores that predictability and perceived autonomy significantly impact stress levels (65), a phenomenon that may explain the observed reductions in both cohorts. Nevertheless, additional longitudinal evaluations are imperative to ascertain whether the intervention yields enduring effects. Collectively, these results bolster the validity of Leventhal’s theoretical framework in enhancing psychological well-being among individuals with chronic ailments (66, 67). However, some investigations have yielded inconclusive outcomes, suggesting that supplementary behavioral or spiritual strategies may be required for sustained benefits (68). The discrepancies in the findings across these studies may be attributed to variations in the nature of the diverse diseases examined. Furthermore, differences in illness perceptions may influence other outcomes. Specifically, illness perception can affect treatment adherence and psychosocial responses, thereby impacting disease-related symptoms and outcomes such as stress, anxiety, and depression (30).

This research analyzed the effectiveness of Leventhal’s self-regulation model in reducing anxiety, stress, and depression in women diagnosed with MS. Although the intervention significantly improved psychological outcomes in the short term, its long-term sustainability remains a subject of debate. Both anxiety and stress improved immediately after the intervention but increased again after one month. The reduction in depression, however, remained stable over time.The results highlight the model’s strength in altering illness perceptions, particularly for depression, likely due to its support for cognitive restructuring and emotional adaptation. However, the temporary nature of anxiety and stress reduction points to the need for more comprehensive and sustained interventions. Despite its advantages, this intervention alone may prove inadequate for long-term psychological management in individuals with MS.

Future investigations should examine multimodal strategies, such as the integration of self-regulation training with cognitive–behavioral therapy (CBT), mindfulness-based interventions, or pharmacological treatments, to increase its overall effectiveness. Furthermore, long-term follow-up assessments are imperative to ascertain the persistence of its effects and to refine intervention methodologies conducive to sustainable mental health enhancements. Additional research should prioritize individualized intervention frameworks and the incorporation of digital or telehealth adaptations to improve accessibility and adherence.