Practice Points
- People with multiple sclerosis (MS) who took part in a structured, 4-step therapeutic patient education (TPE) program exhibited improved mental quality of life (QOL), better understanding of their disease, and reduced anxiety and depression.
- Targeted educational approaches are needed to enhance the physical QOL of people with MS by supporting self-management and daily functional activity.
- TPE programs can be integrated into the overall management of MS and should be adapted as the disease progresses to maintain their relevance and effectiveness.
Multiple sclerosis (MS) is a chronic neurologic disease characterized by immune system dysfunctions that target the central nervous system.1 It affects approximately 2.8 million people worldwide.2 It is an early-onset disease, affecting mainly young adults between the ages of 20 and 40 years,3 a stage of life when they are beginning to make decisions about their social roles and their future.4 Symptoms fluctuate and are unpredictable in terms of progression, frequency, and severity.5 Psychological well-being is also affected by a high prevalence of depression and anxiety, which patients perceive as more troubling than physical symptoms.6-8 Thus, people with MS face a wide variety of challenges on a daily basis, both physically and mentally.3,9 As a result, quality of life (QOL) is significantly impaired, with more adverse repercussions than in other neurologic diseases.4 The QOL of people with MS is frequently lower than that of the general population and even that of patients with other chronic diseases.10
Given the complexity of MS11 and with a view to establishing a more effective health care system that considers the physical, psychosocial, and economic challenges of the disease,9 an integrated and coordinated treatment approach is crucial. This includes disease and symptom management, medication monitoring, education, and tailored strategies to minimize disease burden.9 Therapeutic patient education (TPE) has been shown to be an essential nonpharmacological intervention6,12 and an imperative component in the management of MS.13 TPE is defined as an ongoing process fully integrated into the clinical care of chronic diseases, including MS, with the aim of helping the patient acquire or retain specific skills for optimal disease management and adapted care.14,15 The TPE approach is based on 4 key stages: (1) establishing an educational diagnosis in collaboration with the patient to identify his or her needs, (2) defining the specific skills to be acquired or retained as part of an individualized program, (3) implementing the educational program, and (4) evaluating the achievement of the predefined objectives as well as the process followed.16,17
TPE programs for MS have become widespread in recent years.18 They have been associated with several positive effects, including improving knowledge of the disease and treatments,19,20 reducing anxiety and depressive symptoms, promoting QOL,21,22 improving medication adherence,20,23 and managing fatigue.24 This emphasizes the importance of providing educational and psychological support to people with MS to help them live life to the fullest despite the disease. Furthermore, according to a report by the Consortium of Multiple Sclerosis Centers, education programs play a key role in the management of MS, which are beneficial for patient empowerment and encourage the adoption of appropriate health behaviors.25 They enable people with MS to mobilize internal resources, use problem-solving skills, and make thoughtful decisions to cope with a wide spectrum of unpredictable symptoms, thus helping to maintain optimal QOL.26,27
Given the multitude of challenges encountered during the course of MS and the need for practices that promote better disease management, self-efficacy, and symptom reduction,28 it is crucial to incorporate practices that take a biopsychosocial approach4,29 and that recognize the variety and evolution of patients’ long-term needs due to the chronicity of the disease.4 In other words, it is essential to implement interventions aimed at educating and actively involving people with MS in the acquisition of skills and the adoption of positive behaviors.9 Thus, this exploratory study aims to design and implement, to our knowledge, the first structured TPE program in Morocco for people with MS. The first objective is to evaluate the program’s effect on QOL; the second objective is to examine its effect on anxiety, depression, and patient knowledge.
The a priori hypotheses of the study are:
- The TPE program will induce a significant improvement in the primary outcome measure, QOL, 3 months after the intervention.
- The program will produce significant changes in secondary outcomes, notably a reduction in depression and anxiety, as well as an improvement in knowledge 3 months after the intervention.
Methods
Study Design and Participants
We conducted a quasi-experimental study of people with MS at the Neurology Department of Hassan II University Medical Hospital in Fez, Morocco, between October 2022 and December 2023. They had to meet 3 criteria for study inclusion: age 18 years or older; definitive diagnosis of MS by a neurologist, irrespective of type; and an Expanded Disability Status Scale (EDSS) score between 0 and 8. Exclusion criteria included uncertain diagnosis of MS, the presence of significant cognitive or psychiatric disorders, and exacerbations occurring within the 4 weeks prior to study inclusion. Based on previous studies,30 the minimum sample size, calculated with the G*Power tool, was estimated at 130 participants to obtain an effect size of d≈0.31 for the MS Quality of Life-54 (MSQOL-54) total QOL score between baseline and 3 months post intervention, with a threshold α less than 0.05 and statistical power of 95%. From a total of 245 patients presenting to the neurology department, the sample size was adjusted to 200 participants to compensate for an anticipated attrition rate of 20%,26 corresponding to those who completed the first phase of TPE: the educational diagnosis. The 45 patients who were not included either declined participation, mainly due to limited availability or lack of interest, or faced access difficulties related to their place of residence or reduced mobility associated with advanced disability. These reasons were noted informally during recruitment, without systematic data collection, in accordance with ethical principles. Ultimately, 164 participants successfully completed all stages of the educational intervention up to the evaluation. Due to the absence of a complete patient list, sampling was carried out using a nonprobability convenience method.
Ethical Considerations
The study protocol was approved by the Ethics Committee of the Faculty of Medicine, Pharmacy and Dentistry, at Sidi Mohamed Ben Abdellah University in Fez (registration number: 31/2022). In accordance with the international ethical principles set out in the Declaration of Helsinki, participants were fully informed about the study and gave written informed consent. All personal information was treated confidentially, and no participant data were disclosed in the event of withdrawal from the study.
The TPE Intervention
The description of the intervention was structured in accordance with the Template for Intervention Description and Replication checklist to ensure transparency and reproducibility.
The TPE program for people with MS was designed on the basis of 3 methodological foundations. First is the theory of planned behavior, commonly used in MS educational programs31,32 and widely supported as one of the most robust explanations for understanding particular health behaviors in chronic diseases in general.33,34 Second is cognitive behavioral therapy (CBT), a psychological approach that explores the link between thoughts, associated emotions, and behavioral actions.35 Third, the program was based on the structured conceptual model of TPE16,17 as a continuous and dynamic 4-stage process. In this study, it was implemented to assess its impact on QOL, anxiety and depression levels, and disease-related knowledge.
The intervention was based on structured teaching aids designed to facilitate content understanding and appropriation. We used thematic slide shows, simplified teaching sheets, paper and digital supports, and educational videos, all designed to encourage active learning and reinforce key messages.
The intervention’s 4-stage TPE approach began with an individual educational diagnosis by a qualified health care professional of the participant’s needs, expectations, knowledge, and psychosocial characteristics. Based on this assessment, personalized objectives were defined, focusing on the development of self-care and adaptation skills.16,17 These objectives were the focus of the educational sessions, with the content and teaching methods chosen through an active, participatory approach. Last, there was a formal evaluation of the intervention to assess the skills developed by the participants and to consolidate the appropriation of the educational messages.
Prior to the official start of the intervention, to test the clarity of the materials and the consistency of the content, 20 participants gave feedback on the program and pedagogical adjustments were made based on it, including the simplification of certain written supports and a forward-looking reorganization of the sequence flow.
Over a 2-month period, participants met face-to-face twice. The first meeting was a 3-hour interactive group session, conducted in subgroups of 15 to 20 patients and led by 2 neurologists and 4 psychologists. The second meeting was a 1-day seminar, divided into 3 thematic modules of 1 hour each and led by an occupational therapist, a dietitian, and a physiotherapist trained in TPE. The sessions took place at the Neurology Department of the Hassan II University Hospital and at the Faculty of Medicine, Pharmacy and Dental Medicine of Fez.
A variety of techniques were used to engage participants, including brainstorming, question and answer sessions, group discussions, practical demonstrations, and educational aids. At the end of each session, some of the participants were invited to present an oral summary of the points covered, reinforcing the integration of what they had learned. Sessions were systematically adapted to the needs and priorities expressed, highlighting the complex realities of living with MS. Expert patients were invited to contribute to the program by sharing their experiences and experiential knowledge, and participants’ relatives or partners were also encouraged to attend to reinforce social support.
As part of this implementation, the first session introduced the program’s objectives with an explanatory document given to each participant. It covered the pathophysiology of MS, disease-modifying therapies, and relapse management; daily symptom management; and how to recognize emotions, restructure negative thoughts, and learn positive coping behaviors. The seminar was structured around 3 complementary foci: fatigue management and energy-saving strategies, the importance of physical activity, and the principles of a suitable diet.
No systematic measures of intervention fidelity were formally planned; however, the program’s consistency was ensured by a team of trained facilitators, using standardized materials and a common pedagogical reference chart specifying the skills, objectives, content and methods corresponding to each session (Table 1). This structure ensured consistency of content and messages throughout the intervention.
Outcomes and Instruments
Sociodemographic data (sex, age, education level, marital status, occupation, and region of residence) and clinical data (age at diagnosis, duration of disease, type of MS, and EDSS score) were collected at baseline for 164 patients. Intervention results were collected at baseline (T0) and at a 3-month follow-up (T1).
Primary Outcome
The validated Arabic version of the MSQOL-54 questionnaire, adapted to the Moroccan context,36 was used to assess QOL, the primary outcome. Cronbach α was equal to or greater than 0.70, indicating good internal consistency between the questionnaire’s items. The questionnaire has 12 subscales: physical function, health perception, health distress, role limitation-physical, sexual function, role limitation-emotional, pain, energy, social function, emotional well-being, cognitive function, and overall QOL. There are also 2 independent measures assessing change in health and satisfaction with sexual function. The patient’s QOL score is calculated by summing 2 composite scores, the physical composite score (PCS) and the mental composite score (MCS).37 Each subscale was evaluated according to the scores attributed to each question, rated on a scale from 0 to 100. Higher scores indicate better QOL.
Secondary Outcomes
The validated Moroccan version of the Hospital Anxiety and Depression Scale was used to assess symptoms of anxiety and depressive disorders.38 This internationally recognized tool consists of 14 items scored from 0 to 3, with 7 items assessing anxiety and 7 assessing depression. The 2 scores range from 0 to 21. For ease of interpretation, scores between 0 and 7 indicate an absence of symptoms, whereas scores above 7 indicate presence of symptoms.39 The reliability of Cronbach α, evaluated at 0.87, is considered good.38
Participants’ knowledge of MS was assessed using the Arabic version of the MS Knowledge Questionnaire.40 It consists of 25 multiple-choice questions with 3 to 5 possible answers. One point is awarded for each correct answer. Thus, the minimum possible score is 0 points and the maximum score is 25 points.40,41 A reliability assessment of the Arabic version revealed an acceptable Cronbach α coefficient of 0.773.
Data Analysis
For descriptive analyses, means and SDs were calculated for quantitative variables, whereas percentages and frequencies were used for categorical variables. The Kolmogorov-Smirnov test results showed a non-normal distribution of the data, which led to the use of the Wilcoxon signed rank test to compare the difference between change scores. Results were expressed as medians and IQRs for variables including the PSC, MCS, QOL subscales, and anxiety, depression, and knowledge scores. Data analysis was performed with IBM SPSS Statistics version 26.0, with a significance level set at P< .05.
To assess the impact of the intervention, the statistical effect size (r) was determined using the following formula: r =Z/√N, where Z is the test statistic obtained with SPSS and N is the total number of participants.42 Interpretation thresholds were low (r = 0.1), moderate (r = 0.3), and high (r = 0.5).43
Results
Of the 200 patients initially enrolled, 164 took part in the TPE program through the evaluation phase of the educational workshops. Table 2 presents the sociodemographic and clinical characteristics of the participants. Of these, 76.2% were women, the average age was 38.42±11.42 years, 55.5% were married, 80.4% lived in urban areas, 34.1% had a university education, and 60.4% were not professionally active. Regarding clinical data, the most frequent subtype was relapsing-remitting MS, observed in 92.7% of patients. The mean age at diagnosis was 33.26±10.7 years, the mean EDSS score was 1.64±1.57, and the mean disease duration was 65.21±58.48 months.
Primary Outcome
Comparing T0 measures with those at T1, the nonparametric Wilcoxon test revealed that the MSQOL-54 MCS showed a significant improvement. Median scores increased from 51.39 (IQR, 41.26- 66.89) to 63.60 (IQR, 53.26-73.77) with a large effect size (P <.001; r = 0.54). With the exception of cognitive function, which showed no significant difference (P= .83), the other MCS subscales showed significant improvement, with effect sizes ranging from small to moderate. Scores for health distress, general QOL, emotional well-being, and emotional state limitations increased significantly from 50.00 (IQR, 40.00-70.00) to 60.00 (IQR, 45.00-75.00) (P = .01; r = 0.13), from 48.32 (IQR, 36.65-68.35) to 53.32 (IQR, 41.65-68.35) (P <.001; r = 0.43), from 52.00 (IQR, 48.00- 60.00) to 60.00 (IQR, 56.00-80.00) (P <.001; r = 0.21), and from 33.33 (IQR, 0-66.67) to 100 (IQR, 66.67-100) (P < .001; r = 0.34), respectively.
In contrast, MSQOL-54 PCS showed no significant improvement after the intervention, with the median increasing from 55.72 (IQR, 37.16-69.65) to 61.98 (IQR, 41.45-71.02) (P= .06; r = 0.10). Of the 8 PCS subscales, only 3 showed a significant difference, although the effect sizes were small. Health perception, distress, and social function scores showed significant improvement from 50.00 (IQR, 35.00-70.00) to 60.00 (IQR, 31.25-70.00) (P = .04; r = 0.11), from 50.00 (IQR, 40.00-70.00) to 60.00 (IQR, 45.00-75.00) (P = .01; r = 0.13), and from 58.33 (IQR, 50.00-75.00) to 75.00 (IQR, 41.66-75.00) (P = .05; r = 0.10), respectively. No improvement was observed in the PCS subscales of physical function, physical health limitations, sexual function, pain, and energy.
For the independent MSQOL-54 subscales, change in health showed a significant improvement from 50.00 (IQR, 25.00-50.00) to 75.00 (IQR, 25.00-75.00) after the intervention, with a small effect size (P = .05; r = 0.10). However, satisfaction with sexual function showed no significant change (P = .51; Table 3).
Secondary Outcomes
A significant reduction in the anxiety score was observed after the intervention from 9.00 (IQR, 7.00-10.00) to 5.00 (IQR, 2.00-7.00) post intervention, with a large effect size (P <.001; r = 0.5). Furthermore, although participants initially had normal depression scores at T0, a significant decrease was observed at T1 from 7.00 (IQR, 4.00- 8.00) to 5.00 (IQR, 3.00-6.00). This decrease was associated with a high effect size (P<.001; r = 0.55). Similarly, the knowledge score increased significantly from 5.00 (IQR, 4.00-7.00) to 12.00 (IQR, 10.00-14.00) after intervention, with a very high effect size (P <.001; r = 0.61; Table 4).
Discussion
The aim of this study was to implement a TPE program for people with MS and assess whether this intervention improved QOL, anxiety, depression, and disease knowledge. Our results partially support the hypothesis that TPE significantly improves overall QOL. On the other hand, the results support the hypothesis that there is a significant improvement in depression, anxiety, and knowledge post educational intervention. A statistically significant increase in MCS in QOL, with a large effect size (r= 0.54), was observed after 3 months of the intervention. In contrast, no significant change was observed for PCS, although scores on its subscales of social function, perception, and health distress showed significant improvements. Findings from several previous studies44-48 have revealed the positive impact of TPE programs for people with MS, with a greater effect on mental than physical QOL. Although others have shown improvement in all dimensions of QOL as assessed by the MSQOL-54,30,49 systematic reviews have suggested that significant improvement in mental QOL components was more common than in physical QOL components.21,22 However, the majority of these studies assessed QOL using the 36-Item Short Form Health Survey, which is not designed to measure behavioral changes in MS-specific aspects,50,51 partially limiting the comparison of results obtained using the MSQOL-54.
Our results suggest a positive effect, with the TPE program playing a crucial role in promoting mental QOL by strengthening patients’ skills in managing psychological well-being, emotional vitality, and the ability to cope with mental challenges associated with MS. Indeed, all subscales of the MCS showed significant improvement with small to moderate effect sizes: general QOL, emotional well-being, limitations related to emotional state, and health distress. However, cognitive function was the only subscale to show no effect after the intervention, as supported by findings from other studies.52,53 This result could be explained by the fact that our program did not include specific interventions aimed at remedying cognitive disorders and improving patients’ ability to manage them in their daily lives.
In line with findings from other previous studies that have evaluated TPE programs in MS,30,49 significant improvement was observed in 3 PCS subscales with small effect sizes: social function, health perception, and distress. These results may reflect a better perception of well-being, health, and the management of their chronic disability.54 A positive evolution was also observed in the ability to interact socially, maintain relationships, and participate actively in social activities.55 However, no improvement was observed in the PCS subscales of physical function, physical health–related limitations, sexual function, pain, and fatigue. This lack of change could be explained by the fact that the educational intervention did not provide sufficiently direct or specific strategies to significantly influence physical outcomes as well as by the participants’ relatively mild to moderate physical impairments, which did not have a noticeable impact on their daily activities.44 The participants’ mean EDSS score was 1.64±1.57, indicating a mild level of disability. Disability level is recognized as a major factor influencing physical QOL.56,57 This relatively low average can be explained by lower participation by the most severely affected patients due to functional limitations and geographical constraints.
The findings indicated that sexual function did not show significant improvement after the intervention. However, findings from some previous studies30,49 that have evaluated TPE programs in people with MS have reported improvements in this dimension. This discrepancy may be attributed to cultural factors58 that limited participants’ willingness to openly share and discuss their sexual concerns with facilitators. A holistic approach is recommended for sexual function, often underestimated in Arab sociocultural contexts, where discussing sexual health remains taboo despite its significant impact on QOL.59 Thus, it is important that the partner actively participate in the educational process by exploring strategies for self-management and coping with sexually disruptive symptoms as well as available therapeutic options.59 Generally, the health change subscale showed significant improvement after the TPE program, in line with findings from other studies.49 Although the PCS showed no significant change, unlike the MCS, participants perceived an overall improvement in their health. This evolution mainly concerns psychological and emotional aspects, which are crucial for the overall QOL of people with MS.
Our results also revealed that at baseline, participants showed that they had anxiety disorders, not depression. This corresponds to a meta-analysis that concluded that anxiety is more prevalent than depression in people with MS. After 3 months of intervention, there was a significant reduction in both anxiety and depression scores, with high effect sizes (r = 0.50 and r = 0.55, respectively). These results, also reported by several studies of TPE programs applied to MS,21,30,60-62 can be attributed to the integration of CBT tools in our educational approach. Mobilized across the board, these techniques helped strengthen coping and self-management skills, thus supporting the improvement of participants’ psychological well-being.63,64 By promoting the development and reinforcement of self-management skills and coping abilities, CBT can contribute to improving the QOL of people with MS.65 However, other educational programs have reported no significant difference in the reduction of anxiety and depressive disorders.62,66,67 This could be explained by a lack of diversity in the selection criteria of study participants, who tend to be young patients at the beginning of the disease course with a low or moderate level of disability and without pronounced symptoms of depression or anxiety.21 People
with MS with less pronounced physical limitations are significantly less likely to experience psychological distress.68 In general, heterogeneity in the effectiveness of educational programs for the management of symptoms associated with chronic diseases, particularly MS, may be due to variability in the design of educational interventions in terms of objectives, content, and approaches used as well as session delivery and evaluation modalities.9,22,26,69 Furthermore, the peer support inherent in the educational intervention probably contributed to the observed reduction in symptoms by encouraging emotional expression and the sharing of experiences. This mechanism is recognized for its beneficial effects on mental health, including in people with MS.70,71
Our results showed that after our educational intervention, a significant improvement in MS knowledge was observed at 3 months of follow-up, with a high effect size (r =0.61). This finding corroborates data from several previous studies evaluating TPE programs in people with MS.72-79 Participants had an average illness duration of 65 months, so this improvement is significant. It can be explained by the absence of formalized TPE in the participants’ previous experience as well as by a low level of education among nearly 40% of the participants. Predictions of disease course are complex.65 It is therefore increasingly crucial to have access to well-developed, unbiased, and up-to-date information to increase knowledge of disease types, pathophysiology, and types of medication and their efficacy.80 The aim is to make informed decisions, optimize satisfaction with the care system,73 and consequently improve QOL.81 Furthermore, clinical outcomes can be affected by patients’ knowledge of their disease, influencing their ability to self-manage, adapt, and adhere to treatment.82 Findings from several studies have highlighted a lack of knowledge among people with MS.80,83,84 In this respect, the implementation of adapted educational programs is essential to improve knowledge, understanding, and emotional balance.80 Knowledge is now seen as a relevant indicator for measuring the effectiveness of educational programs and the involvement of the individual.73,83
To our knowledge, this study constitutes the first structured educational intervention conducted in Morocco for people with MS, integrating the key stages of TPE, with an original contribution of CBT aimed at strengthening emotional and behavioral skills. However, the absence of a control group limits comparisons and exposes the study to biases, such as confounding factors and contextual effects. A randomized controlled trial would be relevant in the future to strengthen internal validity.
The relatively short follow-up duration may not be sufficient to capture lasting effects, particularly on the physical components of QOL. Finally, the seminar format of the second session, imposed by logistical constraints, may have reduced the educational impact.
Conclusions
Our results suggest that this TPE program may be effective in improving mental QOL and MS-related knowledge as well as in reducing anxiety and depression in people with MS. Although some physical subscales showed significant improvements, the overall effect on physical QOL remained limited. As a result of the intervention, people with MS acquired essential skills to better manage the challenges associated with their illness. Given the unpredictable and variable nature of MS as well as the specific needs of patients, it is crucial that health care partners integrate and optimize tailored educational programs from the moment of diagnosis in order to maximize the benefits for overall QOL.
