Psychoeducation for Fibromyalgia Syndrome: A Systematic Review of Emotional, Clinical and Functional Related-Outcomes

Fibromyalgia Syndrome (FMS) is a chronic condition of widespread pain accompanied by several symptoms such as stiffness, fatigue, sleep problems, depression, anxiety, and cognitive deficits. To date, there is no specific treatment for FMS. The European League Against Rheumatism, and the majority of the international recommendations for managing FMS, has claimed psychoeducational intervention as the first step in FMS treatment for adequate symptoms management. However, scientific studies in this regard are scarce, diverse, and with contradictory findings. Results integration from analogous studies could provide a clear presentation of the real clinical value of psychoeducation in FMS. Therefore, the current systematic review aims at exploring the effect of psychoeducation on emotional, clinical, and functional symptoms of FMS patients and encourages researchers towards psychoeducation’s procedure optimization and systematization. The systematic review was conducted according to the guidelines of the Cochrane Collaboration and PRISMA statements. The selected articles were evaluated using the Cochrane risk of bias (ROB) assessment tool. The selected articles were extracted from PubMed, Scopus, and Web of Science databases. The literature search identified 11 studies eligible for the systematic review. The ROB evaluation revealed that 2 of the 11 studies showed a low quality, the other 2 had a moderate quality, and the remaining 7 studies exhibited a high quality. Results showed that psychoeducation is generally included as an important first therapeutic step in multicomponent treatments for FMS. Moreover, psychoeducation generally seems to be quite beneficial in reducing emotional (i.e., number of days feeling emotionally well, general anxiety, depression levels, etc.) and clinical symptoms (levels of fatigue, morning stiffness, pain intensity, etc.), as well as increasing functional status (i.e., general physical function, morning fatigue, stiffness, etc.). Despite that psychoeducation´s clinical benefits are highlighted, there is scarce amount of research on psychoeducation beyond its usefulness as part of multicomponent treatments.


Introduction
Fibromyalgia Syndrome (FMS) is conceptualized as a chronic condition of widespread pain accompanied by fatigue, sleep problems, depression, and anxiety [1][2][3]. In addition, there is also evidence of cognitive problems in FMS (also called "fibro fog" [4,5]), comprising deficits in attention, perception, concentration, memory, and higher cognitive functions [4,[6][7][8][9]. Its prevalence is estimated in 2-4% of the general population, being more frequent in women than in men [2]. In this detail, recent research showed a possible gender bias that seems to lead professionals to underestimate FMS prevalence in men and overestimate it in women [8,9]. FMS negatively impacts the health-related quality of life, especially in activities of daily life, work, career, parenting, interpersonal relationships, and mental health [10][11][12][13].
on the present moment through meditation, conscious breathing, body scan, and mindful movements [68][69][70]. ACC therapy attempts to increase psychological flexibility, pain acceptance, and treatment process commitment in FMS [77]. Psychological flexibility allows FMS patients to accept and manage a variety of unavoidable events associated with pain, instead of investing energy in fighting with them. ACC reduces avoidance behaviors, facilitates acceptance and contact with the present, and promotes a state of mental calm [71,72,78].
On the subject of moderate exercise interventions, FMS patients are advised to avoid a sedentary lifestyle and keep active at the physical and social levels [62]. The Body Mass Index (BMI), social isolation, general functioning, and well-being are demonstrated to be improved and controlled by exercise and physical activity interventions [60,70,79,80]. Obesity seems to be a common problem in FMS patients which is associated with greater pain sensitivity, poorer sleep quality, reduced physical strength and flexibility [81,82], and marked reduction of cognitive performance [82].
Most therapy approaches directed to FMS patients include psychoeducation as the first phase of the treatment due to its relevance in patients' adherence and prognosis [66,67]. Indeed, according to the European League Against Rheumatism (EULAR) recommendations for managing FMS, psychoeducational intervention has to be the first mandatory step in FMS patients' treatment [83]. In line with the above, Multidisciplinary Pain Education Programs (MPEP) have been observed to be significantly beneficial in Central Pain Sensitization (CPS) conditions [84,85]. FMS is well-known to be the prototypical CPS condition [86].
Broadly, the main purposes of educative interventions are: (1) to give patients and caregivers the necessary information about the pathologies characteristics and treatment options; and (2) to provide details on potential positive effects on family functioning and patient behavior [87]. Patient s education may be defined as any set of educative activities planned by qualified professionals and aimed at providing information and/or restructuring the patients disease perception and, therefore, improving patients' healthrelated behaviors and/or status [88].
FMS s psychoeducation generally involves information about the distinction between acute and chronic pain, FMS nature, disease contributing factors, treatments that are most safe and effective, and the symptoms characteristics; and coping strategies, among others [83,[89][90][91]. Moreover, educative programs may contribute to increase therapeutic adherence as previously reported, self-confidence, self-esteem, and pain self-efficacy in FMS patients [92]. An efficient psychoeducation in FMS patients might positively impact the disease's treatment and prognosis [92].
As a whole, patient education, as a part of a wider multidisciplinary program, might be not only useful but crucial for FMS patients' symptom management [67,89]. Psychoeducation in FMS patients may increase the knowledge and understanding of the disease, being a therapeutic strategy itself that positively impacts the rest of the treatment [62,93,94]. To the extent that patients understand what FMS is and deconstruct the myths surrounding this disease: (1) a better active and healthy facing of the disease will be achieved [95]; (2) FMS patients will be more likely to draw upon support networks and socio-health resources [95]; and (3) to develop a more favorable attitude towards the disease, which will also have a potential impact on the disease treatment and prognosis [93][94][95].
Nonetheless, further research is needed to determine a framework from which to develop non-pharmacological interventions (i.e., psychological therapies) guidelines in FMS [15], including the optimization and systematization of psychoeducational programs. Scientific studies in this regard are scarce, methodologically diverse (i.e., different combinations of therapies, several protocols of psychoeducation, variability related to the number of sessions of psychoeducation, etc.), and with findings in different directions [83,86]. Results integration from analogous studies could provide a clear presentation of the real clinical value of psychoeducation in FMS.
Based on the previous aforementioned literature, the current systematic review intended to: (1) explore the effect of psychoeducation on emotional (e.g., depression and anxiety), clinical (e.g., pain), and functional (e.g., fatigue, health-related quality of life and impact s disease) FMS related-outcomes; and (2) encourage further research on clinical settings psychoeducation methodization.

Search Strategy
This systematic review was performed according to the guidelines of the Cochrane Collaboration and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) [96]. The search terms were as follows: "fibromyalgia" and "psychoeducation". The terms were extracted from the Medical Subject Headings (MeSH). The PICO question was: what is the effect of psychoeducation on emotional, clinical, and functional related outcomes in FMS?
The selected articles were extracted from PubMed, Scopus, and Web of Science databases. All articles were screened; those that fulfilled the inclusion criteria for fulltext analysis were selected. Among these, the titles and abstracts were revised to remove those not relevant for the review. Afterward, the resulting articles were screened in depth for eligibility. To attain a final set of articles to be reviewed, the full texts of relevant articles were retrieved and screened based on the inclusion and exclusion criteria. The PRISMA flowchart ( Figure 1) shows the screening and selection process for the inclusion of studies. The last search was conducted on 1 February 2023.

Eligibility Criteria
Inclusion criteria were as follows: (1) peer-reviewed original studies of FMS and psychoeducation (i.e., longitudinal studies, pilot studies, pilot randomized controlled trials, randomized controlled clinical, quasi-experimental replicated single-case/small group designs, and uncontrolled and controlled pre-post-test studies); (2) studies comprising adult patients (≥18 years old) with an official diagnosis of FMS; and (3) studies written in English. The exclusion criteria were: (1) review article or meta-analysis; (2) comment, editorial, case report, letter, or meeting/congress abstract; and (3) non-English publication.

Data Extraction and Quality Assessment
The study characteristics, methodologies, and results were extracted independently by C.M.G.-S. and C.I.M. in the following sequence: first author, study name, country, year of publication, study design, sample size and the number of participants in each study group, participant age and sex, and the diagnostic criteria of FMS. The study characteristics are presented in Table 1.
With the objective of assessing the quality of the selected articles, the risk of bias (ROB) in each study was evaluated by C.M.G.-S. and C.I.M. according to the Cochrane ROB assessment tool. This tool comprises seven items evaluating ROB: random sequence generation (selection bias), allocation concealment (selection bias), blinding of participants and personnel (performance bias), blinding of outcome assessment (detection bias), incomplete outcome data (attrition bias), selective reporting (reporting bias), and other bias. For each item, the ROB was graded as high, medium, or low. Moreover, the global quality of each article was also assessed.

Data Synthesis
In view of the aim of the current systematic review, the authors checked each study s main objectives, the methodology, and if there were or were not control groups included. In addition, the characteristics and purposes of FMS psychoeducational programs (i.e., the effect on emotional, clinical, and/or functional symptoms, the content of sessions, the number of interventions, etc.) were analyzed together with the pre-post and follow-up results. The clinical relevance of the main findings and the principal limitations of each research were also determined (see Table 1 for more detail). In addition, the specific subjectmatter of the FMS psychoeducational programs are detailed in Table 2. Finally, the biases of each study were analyzed and reported in the Section 3.4 and Table 3 The latter analyses were performed to determine the effect of psychoeducation in FMS with the commitment to improve FMS clinical intervention and guide future research lines in this field.

Literature Search and Study Characteristics
From among a total of 62 articles identified by database searches, 21 were finally selected for screening after removing duplicates. A general PRISMA flow chart was devised detailing the number of studies excluded at each stage of the screening (Figure 1). An analysis of 11 full-text articles was conducted in order to determine their eligibility for the present review. Only 11 articles fulfilled the inclusion criteria; therefore, they were subjected to the data extraction (Table 1) and quality assessment (Table 3) processes. The selected studies were published between 2002 and 2022. Of the 11 studies, 1 was a Delphi technique [97], 2 were pilot studies [98,99], and 8 were randomized controlled trials [100][101][102][103][104][105][106][107]. Four studies were conducted in Spain [98,[100][101][102], 2 in Sweden [99,107], 2 in Canada [104,105], 1 in The United States of America [106], 1 in Ireland, the United Kingdom, North America, and other non-specified countries [103], and 1 in Brazil [97]. The 11 selected studies included a total of 1659 participants (age range: 27-60 years old), of which 1073 were FMS patients. main objectives, the methodology, and if there were or were not control groups included. In addition, the characteristics and purposes of FMS psychoeducational programs (i.e., the effect on emotional, clinical, and/or functional symptoms, the content of sessions, the number of interventions, etc.) were analyzed together with the pre-post and follow-up results. The clinical relevance of the main findings and the principal limitations of each research were also determined (see Table 1 for more detail). In addition, the specific subject-matter of the FMS psychoeducational programs are detailed in Table 2. Finally, the biases of each study were analyzed and reported in the Risk of Bias section and Table 3 The latter analyses were performed to determine the effect of psychoeducation in FMS with the commitment to improve FMS clinical intervention and guide future research lines in this field.

Literature Search and Study Characteristics
From among a total of 62 articles identified by database searches, 21 were finally selected for screening after removing duplicates. A general PRISMA flow chart was devised detailing the number of studies excluded at each stage of the screening (Figure 1). An analysis of 11 full-text articles was conducted in order to determine their eligibility for the present review. Only 11 articles fulfilled the inclusion criteria; therefore, they were subjected to the data extraction (Table 1) and quality assessment (Table 3) processes. The selected studies were published between 2002 and 2022. Of the 11 studies, 1 was a Delphi technique [97], 2 were pilot studies [98,99], and 8 were randomized controlled trials [100][101][102][103][104][105][106][107]. Four studies were conducted in Spain [98,[100][101][102], 2 in Sweden [99,107], 2 in Canada [104,105], 1 in The United States of America [106], 1 in Ireland, the United Kingdom, North America, and other non-specified countries [103], and 1 in Brazil [97]. The 11 selected studies included a total of 1659 participants (age range: 27-60 years old), of which 1073 were FMS patients.   (1) To try the feasibility of ASSA in a Swedish primary care setting; (2) to explore associations between symptoms of depression, anxiety, alexithymia, and MUPS.
Pilot Study. * ¤ Procedure: ASSA began with 8 group sessions-'the Affect School', which were followed directly by 10 individual sessions-'the Script Analysis'. All 27 respondents one-week post-intervention terminated ASSA within 20 weeks from the start. Script Analysis sessions were performed with one instructor, either the physiotherapist, the GP, or one social counselor. Affect School comprised 8 weekly, 2-h sessions, of a 5-7 participant group, led by the same instructors (one psychotherapist, one physiotherapist, and one GP) during all sessions. Patients: one-week post-intervention median test score changes were significantly favorable for 9 of 11 measures (depression, anxiety, alexithymia, MUPS, general health, self-affirmation, self-love, self-blame, and self-hate); at 18 months post-intervention the results remained significantly favorable for 15 respondents for 7 of 11 measures (depression, alexithymia, MUPS, general health, self-affirmation, self-love, and self-hate). (1) To examine the effectiveness and cost-utility for FMS patients of MBSR as an add-on to treatment as usual (TAU) versus TAU + the psychoeducational program FibroQoL, and versus TAU only; (2) to examine pre-post differences in brain structure and function, as well as levels of specific inflammatory markers in the three study arms; and (3) to analyze the role of some psychological variables as mediators of 12-month clinical outcomes. FMS patients: the intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who reported pain relief and perceived overall improvement on their pain levels, functioning, and quality of life were significantly higher in the INT Group than in the WL Group. The same differences were observed 3 months post-intervention. The results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary and secondary outcomes. FMS patients who received psychoeducation: a 2-month psychoeducational intervention improves the functional status to a greater extent than usual care, at least in the short-term. The social desirability bias did not explain the reported outcomes. Trait anxiety was associated with response to treatment. To evaluate the effects of pool exercise in patients with fibromyalgia and chronic widespread pain and to determine characteristics influencing the effects of treatment.
Randomized controlled trial. * ¤ Procedure: 20-session exercise programme combined with a standardized 6-session education programme based on self-efficacy principles with an active control group, which undertook the same education programme.  1990 ACR.

Primary outcomes:
Change in physical function from baseline to completion of the intervention (FIQ and SF-36).

Secondary outcomes:
Social and emotional function, symptoms (FIQ, the bodily pain and vitality subscales of the SF-36, and BDI). Self-efficacy (adapted Arthritis Self-Efficacy Scale).
FMS patients: progressive walking, simple strength training movements, and stretching activities improve functional status, key symptoms, and self-efficacy in women with fibromyalgia actively being treated with medication. The benefits of exercise are enhanced when combined with targeted self-management education. Appropriate exercise and patient education be included in the treatment of fibromyalgia.

FMS Diagnostic Criteria Instruments and Variables Results
King et al. (2002). The effects of exercise and education, individually or combined, in women with fibromyalgia. Canada [105].
To examine the effectiveness of a supervised aerobic exercise program, a self-management education program, and the combination of exercise and education for women with fibromyalgia (FMS).
Randomized controlled trial with repeated measures design. * ¤ Procedure: The intervention programs were based upon principles of self-management (Bandura's social cognitive theory). Treatment programs ran simultaneously for 12 weeks. Due to the large number of subjects required, the programs were offered on 5 different occasions over a 2 year period (winter-spring once, fall-winter, and spring-summer twice each). Education Group: met once a week for one and a half to 2 h per session. Exercise and education group: combined exercise and education programs. The educational component was the same as for the education-only group. The exercise-only group met twice per week and on the third day met for education and then exercise. Control group: On the day of the initial assessment, they were given a page of instructions for basic stretches and 5 items related to general coping strategies. They were contacted once or twice throughout the 12-week period to ensure they were filling out their logbook and to answer any questions. Subjects from the control group were offered one of the intervention programs at the end of the follow-up period.

Psychoeducation and Emotional, Clinical, and Functional Related-Outcomes in Fibromyalgia Syndrome
Psychoeducation has generally been included as part of the multi-component treatments for FMS patients and the success of these treatments has in fact been attributed to the characteristic combination of therapeutic strategies [98,[102][103][104][105][106][107].
The first group of researchers proposed a multi-component program, namely the MINDSET (MINDfulneSs & EducaTion) program [98], which combined mindfulness and psychoeducation. In the reference study, Pérez-Aranda et al. [98] found that affiliative humor and positive/negative ratio humor styles had a unique predictive effect on selfreported clinical changes [98]. Additionally, significant correlations between humor styles and functional impact and mindfulness facets were also reported [98]. The authors concluded that some humor styles may imply a better disposition in patients to learn and implement the concepts and resources offered by mindfulness and psychoeducation sessions [98]. Participants showed a notable degree of adherence (74% of attendance to the sessions) and considered the intervention satisfactory (9/10), useful (8.9/10), recommendable (8.7/10), and non-aversive (0.5/10), in a post-treatment ad-hoc opinion survey [98].
Other researchers also combined psychoeducation with mindfulness-based therapies. For instance, Feliu-Soler et al. [102] created a protocol to evaluate the cost-utility and biological underpinnings of a Mindfulness-Based Stress Reduction (MBSR) intervention versus a psychoeducational program (FibroQoL) for FMS. The protocol proposed a 12-month randomized controlled trial (EUDAIMON study) with the purpose of: (1) analyzing the aforementioned cost-utility; (2) examining pre-post differences in brain structure and function; (3) determining the level of specific inflammatory markers in the three study arms or branches; and (4) exploring the mediational role of psychological variables on the 12-month clinical outcomes [102]. Unfortunately, the protocol remains to be tested.
Similarly, Dowd et al. [103] compared an Online Mindfulness-based Cognitive Therapy Intervention (MIA) with an Online Pain Management Psychoeducation (PE), in a randomized controlled study. Dowd et al. [103] reported that both groups (i.e., PE and MIA groups) showed improvements on pain interference, pain acceptance, and catastrophizing from pre-treatment to post-treatment and follow-up. Average pain intensity was also reduced from baseline to post-treatment, but not at follow-up, for both groups [103]. Increases in subjective well-being were more pronounced in the MIA than in the PE group [103]. Upon completion of the intervention, MIA group showed a greater reduction in pain 'right now', and an increase in the ability to manage both emotions and stress and enjoy pleasant events [103].
By contrast, Luciano et al. [100] conducted a randomized control trial for testing a multi-component treatment combining usual care and psychoeducation. The psychoeducational intervention consisted in a 2-month program that was proved to improve at short-term the functional status to a greater extent than the usual care [100]. Social desirability bias-also evaluated in Luciano et al. [100]-did not explain the reported outcomes, and trait anxiety was associated with response to treatment [100]. The 12-month follow-up showed a greater improvement on the global functional status, physical functioning, pain, morning fatigue, stiffness, and depression in FMS patients who did receive psychoeducation [101]. The sensitivity analysis suggested that the intervention was cost-effective even after imputing all missing data [101]. As the authors advised, its implementation at primary care will benefit 3 FMS patients rather than 1, as befall with the standard treatment [101].
Multi-component programs combining psychoeducation and physical exercises were also found in three of the reviewed articles [104][105][106][107]. In the study of Bourgault et al. [104] the beneficial effects of a multicomponent interdisciplinary group intervention for the self-management of FMS, named the PASSAGE program, were explored. The PASSAGE program was aimed at reducing FMS symptoms and maintaining optimal function through the use of self-management strategies and patient education. This program included 3 key intervention components: (1) psycho-educational tools; (2) CBT-related techniques; and (3) patient-tailored physical exercise activities. The percentages of patients reporting pain relief and perceiving an overall improvement on pain levels, functioning, and quality of life were significantly higher in the INT Group (Intervention Group) than in the WL Group (Waiting list Group) [104].
King et al. [105] studied the effects of physical exercise (walking exercises) and education, individually or combined, in FMS patients. The authors observed that FMS patients receiving the combination of physical exercise and education, and complied with the treatment protocol, significantly improved their perceived ability to cope with other symptoms.
Likewise, Mannerkorpi et al. [107] implemented an intervention of pool exercise and education for patients with FMS and chronic widespread pain and compared it with single education. Authors observed that the pool exercise-education program showed significant-but lesser-improvement on health status in FMS and chronic widespread pain patients, compared with single education.
Rook et al. [106] combined physical exercise, education, and self-management in an intervention program addressed to FMS patients. Results pointed out that progressive walking, simple strength training movements, and stretching activities enhanced functional status, the characteristics symptoms of the disorder, and self-efficacy in FMS patients [106]. Moreover, the physical exercise s benefits were further intensified when was united with targeted self-management education [106].
Despite the aforementioned results, the reviewed studies showed scarce research on psychoeducation benefits beyond its usefulness as part of multicomponent treatments. Moreover, the differences in the protocol and the variability between interventions were also prevalent. Solely Melin et al. [99] conducted a pilot study to test the effectiveness of a psychoeducation program for depression, anxiety, and alexithymia in FMS and chronic pain patients. Nine of the 11 factors evaluated were significative favorable one-week postintervention. This was the case of depression, anxiety, alexithymia, Medically Unexplained Physical Symptoms (MUPS), general health, self-affirmation, self-love, self-blame, and self-hate. Eighteen months post-intervention, changes remained significantly favorable for 7 of the 11 factors (i.e., depression, alexithymia, MUPS, general health, self-affirmation, self-love, and self-hate) but this result was restricted to 15 patients. Unfortunately, only 6% of the sample included in the study of Melin et al. [99] were FMS patients. Findings must therefore be considered with caution.
It should be not overlooked, the lack of systematization between the different psychoeducation programs analyzed. Reliability and validity analyses of the programs' structure were also predominantly missed. Only Antunes et al. [97] validated the "Amigos de Fibro (Fibro Friends)" program; an educational program to promote health in FMS. On purpose, Antunes et al. [97] informed of an adequate content validity and internal consistency for the program.   Table 2. Cont.
-Introduction and general information. Patients' Expectations. History and epidemiology of FMS. Common symptoms in FMS. Physiological mechanisms involved in the genesis of pain. -Collect information on the goals of each patient, explain differences between physical and emotional pain, clarify differences between hypnosis and self-hypnosis, and administer the hypnotizable test, and hypnosis "safe place". -Information about typical symptoms, usual course, comorbid medical conditions, potential causes of the illness, the influence of psychosocial factors on pain, current pharmacologic and nonpharmacologic treatments, the benefits of regular exercise, and the typical barriers to behavior change.
-Symptoms and explanatory theories for long-lasting pain. The session started by listing the patients' symptoms on a flip chart, followed by a discussion of these symptoms. A short presentation of theories for long-lasting pain was given, followed by a discussion of the participants' own theories and beliefs. A short relaxation exercise was performed while seated. -Pain and pain alleviation. Physical activity and exercise. A short presentation of the local (gate theory) and central (central nervous system) levels of pain modulation and strategies for pain alleviation was given, followed by a discussion of the participants' experience. The participants were encouraged to use different techniques, including physical activity and relaxation. A contract for physical activity for the forthcoming week was written. A short relaxation exercise was performed while seated. -Stress, pain, and depression. Feedback for physical activity during the past week was given and a new contract for activity for the forthcoming week was written. A short presentation of theories about stress was given, followed by the participants' own experience of what makes them stressed and how they prevent and alleviate stress. A short relaxation exercise was performed while seated.
The recognized limitations by authors included: (1) the small number of FMS patients taking part in the studies [98,99]; (2) the lack of a control group [98,99] or an active control group [101]; (3) the absence of other clinical, coping-related, and mindfulness measures [98]; (4) the use of insufficient assessment instruments [101]; (5) difficulties in the control and assessment of the home practice [103]; (6) the non-analysis of common comorbid psychiatric disorders (i.e., major depression, personality disorders, etc.) [100], and other relevant variables such as the pharmacological intake [99]; and (7) the non-report of the follow-up assessments [100]. The last did not let prove whether intervention led to neither permanent improvement on FMS patients' functional status or determine the direct and indirect costs derived from interventions-an aspect especially relevant when policymakers are involved.
The aforementioned biases and limitations need to be overcome in future studies to better understand the effect of psychoeducation on FMS patients and improve the FMS interventions.

Discussion
The present systematic review aimed at exploring the effect of psychoeducation in emotional, clinical, and functional related-outcomes in FMS patients and encouraging further research on clinical settings psychoeducation optimization.
The review confirmed psychoeducation is generally included as a part of other multi-component treatments [98,[102][103][104][105][106][107]. Indeed, among the studies reviewed, only Melin et al. [99] evaluated a single psychoeducational program confirming its feasibility for patients on sick leave due to depression and/or anxiety. Psychoeducation was mostly evaluated in interaction with mindfulness [98,102,103], TAU (Treatment as Usual) [100,101] or physical exercise [104][105][106][107]. On behalf of the first, the MINDSET (MINDfulneSs & Edu-caTion) program [98] demonstrated that some humor styles might lead to higher readiness to learn and use the concepts and resources offered by mindfulness and psychoeducation intervention in FMS patients [98]. Nonetheless, though authors considered MINDSET clinically relevant for the emotions and emotions regulation in the treatment of FMS, the specific effect of psychoeducation sessions was not studied at all.
The EUDAIMON study proposed by Feliu-Soler et al. [102] consisted in a protocol of a 12-month randomized controlled trial, to examine the cost-utility and biological underpinnings of Mindfulness-Based Stress Reduction (MBSR) in comparison with a psychoeducational program (FibroQoL) in FMS. However, as in the above study, no firm conclusion about psychoeducation was drawn. The proposed protocol lacked of a real implementation.
Fortunately, the Online combined program MIA-PE by Dowd et al. [103] did evidence equivalent changes across several evaluated outcomes for participants in both conditions (psychoeducation and mindfulness) over time (e.g., improvements on pain interference, pain acceptance, and catastrophizing and reduced average pain intensity). Even so, the MIA intervention showed a number of unique benefits (e.g., greater reduction in pain 'right now', increases in the ability to manage both emotions and stress and enjoy pleasant events). Note that the level of participant attrition in the study highlighted the relevance of fostering to a greater extent participant engagement in future online chronic pain programs [103]. In this regard, after the situation provoked by the COVID-19 the online therapies have been postulated as essential. COVID-19 consequences have been especially negative for chronic pain patients in general [108], and FMS patients in particular [108]. The wide accessibility and low-cost of online intervention methods establish their offer as rather fundamental and worthy in FMS patients [109][110][111][112].
With respect to TAU and psychoeducation, Luciano et al. [100] showed a greater increase in patients' functional status compared to usual care by itself [100]. Specific improvements were reported in physical function, the total number of days of feeling well, levels of pain, general fatigue, morning fatigue, stiffness, anxiety (less trait anxiety), and depression [100]. In the follow-up of the Luciano et al. [101] study, the long-term clinical effectiveness of the psychoeducational treatment was confirmed in FMS patients [101].
Regarding the multi-component programs incorporating psychoeducation and physical exercises [104][105][106][107], particularly, the PASSAGE [104] program aimed at reducing FMS symptoms and maintaining optimal function through the use of self-management strategies and patient education through sessions involved 3 major components: (1) psychoeducational tools; (2) CBT-related techniques; and (3) patient-tailored exercise activities. Authors informed of significantly greater levels of pain relief and perceived overall improvement on functioning, and quality of life in the INT Group compared to the WL Group [104]. King et al. [105] also reported an enriched in the perceived ability to cope with other symptoms in FMS patients who received the combination of exercise and education and follow entirely the treatment protocol. Mannerkorpi et al. [107] pointed out that the implementation of an education and pool exercise combination in FMS and chronic widespread pain patients led to a slight augmentation in the health status of both patients groups compared with the single education. Consistently, Rook et al. [106] using a program based on Group Exercise (progressive walking, simple strength training movements, and stretching activities), Education, and Self-management in FMS patients observed that progressive walking, simple strength training movements, and stretching activities improved functional status, key symptoms of the disorder, and self-efficacy in FMS patients [106]. Interestingly, the benefits of physical exercise (i.e., progressive walking, simple strength training movements, and stretching activities) increased when combined with targeted self-management education [106].
Hence, the present systematic review confirms psychoeducation as clinically relevant for FMS, but especially when used in combination with other treatments. This entails support for the majority of evidence-based guidelines for the management of FMS that highly recommend multicomponent treatment [83,91,118]. For instance, the Multi-Component Cognitive Behavioral Therapy (MCCBT) for FMS is recommended by Division 12: Society of Clinical Psychology of the American Psychological Association (APA) [73]. The MCCBT for FMS often includes the following components and techniques: (1) education about the syndrome, including its nature and the patient s role in its care; (2) symptom self-management skills targeting pain, fatigue, sleep, cognition, mood, and functional status (e.g., deep relaxation and breathing, graded activation, pleasant activity scheduling, and sleep hygiene); and (3) lifestyle change promoting skills targeting barriers to change, unhelpful thinking styles, and long term maintenance of change (e.g., stress management, goal setting, structured problem solving, reframing, and communication skills) [73].
Despite the reported benefits, it is important to highlight the scarce studies on psychoeducation beyond its usefulness as part of multicomponent treatments and, e.g., the limited small FMS sample size [99]. Indeed, Melin et al. [99] was the only study evaluating a single psychoeducation program, but unfortunately did not account for a satisfying FMS sample size. Further research lines, especially for FMS patients, on psychoeducation effectiveness have been revealed to be required. Research on FMS male patients, and FMS patients from other countries (apart from Europe)-note sociocultural factors influencing psychoeducation interventions-related to the effectiveness of psychoeducation and the etiology of the disease, and/or validation of psychoeducation are encouraged to enhance evidence-based clinical practice in FMS treatment and create and optimize a unique and common protocol between researchers and clinicians. The latter could allow addressing the cost-effectiveness or cost-utility of nonpharmacological treatments in FMS patients.

Conclusions
To conclude, to date, psychoeducation has been generally included in other FMS multicomponent treatments. These multicomponent therapies seem to be useful for FMS treatment, with psychoeducation an undoubtedly essential component. However, the reviewed evidence does not certainly support the total utility of psychoeducation as a single treatment. Its beneficial effects are mostly enhanced in a multi-component treatment or in relation to other interventions. In addition, a lack of a psychoeducational systematic and homogeneous protocol between studies is discerned. Though further research is required, the present findings value the importance of ensuring that patients benefit from the enhancer-positive effects of psychoeducation. Funding: This research was supported by a grant from the Consejería de Universidad, Investigación e Innovación en materia de I+D+i de la Junta de Andalucía (ProyExcel_00374).

Institutional Review Board Statement: Not applicable.
Informed Consent Statement: Not applicable.

Conflicts of Interest:
The authors declare no conflict of interest.