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OBJECTIVE: This study explored the extent to which within-patient changes in processes targeted in Acceptance and Commitment Therapy (ACT) and Behavioral Activation Therapy for Depression (BATD) are associated with changes within-patient in pain intensity and depressed mood and evaluated the extent that process-outcome relationships differed between patients. METHODS: An idiographic analysis embedded within a randomized controlled trial comparing ACT, BATD, and treatment-as-usual (TAU) was conducted to examine the strength of the relationship between outcomes and process variables in patients with chronic low back pain (CLBP) plus depressive symptoms. Based on data from ecological momentary assessment in patients (n = 82), the level of heterogeneity and the pooled effects of these relationships during the intervention period (70 days) were explored. RESULTS: Overall, a high level of heterogeneity was identified in the relationship between pain intensity or depressed mood and psychological inflexibility or behavioral activation. Individual differences in the relationships between outcomes and process variables were identified in individual people during the intervention period. These individual differences appear independent of the group (ACT, BATD, and TAU) and other definable differences (responders/non-responders, completers/non-completers, and clinical depression/non-clinical depression). CONCLUSIONS: These findings suggest the potential utility of personalizing psychological interventions according to the therapeutic needs of these patients.
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BACKGROUND: The Patient Health Questionnaire-4 (PHQ-4) is an ultra-brief instrument that measures depressive and anxiety symptoms. Although it has been frequently used in the last 15 years, no research has systematically reviewed its psychometric properties. OBJECTIVE: This systematic review summarized, for the first time, the available published evidence on the psychometric properties of the PHQ-4. METHODS: This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and was registered in the Prospective Register of Systematic Reviews, under the identification code CRD42022381809. The search strategy was applied in Medline, PsycINFO, Web of Science, and SCOPUS from 2009 (year of publication) to 2023 (present). Two independent reviewers performed screening, data extraction, and methodological quality assessment of the studies. The data was reported through a narrative synthesis. RESULTS: In total, 26 studies involving 93,466 participants from 19 countries, with clinical and nonclinical samples, were included. The two-factor structure was the most frequent, being invariant according to gender, age, geographic location, income, educational level, and language. The internal consistency was adequate for distress (α from 0.72 to 0.88), as well as for depression (α from 0.65 to 0.81) and anxiety (α from 0.74 to 0.84). The temporal stability of the instrument was verified through test-retest reliability, reporting an acceptable connection between both measures. Correlations with related measures were significant and in the expected direction. CONCLUSIONS: The PHQ-4 is a reliable and valid instrument for screening depressive and anxiety symptoms, both for the clinical and nonclinical populations. Due to the brevity of its administration, the PHQ-4 could be a clinical tool that contributes to optimizing health resources.
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Central sensitization (CS) involves an amplification of neural processing within the central nervous system that can result in widespread pain patterns and hypersensitivity to stimuli. The Central Sensitization Inventory (CSI) and various quantitative sensory testing (QST) methods purport to assess clinical markers of CS. The purpose of this systematic review and meta-analysis was to summarize and quantify the associations between total CSI scores and QST measures from previous studies. A systematic search identified 39 unique studies that were deemed eligible for the systematic review and 33 studies for meta-analyses (with 3314 subjects and 154 effect sizes), including five QST modalities: conditioned pain modulation, temporal summation, pressure pain threshold, heat pain threshold, and cold pain threshold. The meta-analysis yielded statistically significant CSI-QST correlations in total subject samples for all five QST modalities. The strongest associations were identified between CSI scores and pain threshold testing, especially pressure pain threshold, in which 51% of effects sizes, from 29 studies and 3071 subjects, were determined to be in a medium to large range.
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Sensibilización del Sistema Nervioso Central , Dimensión del Dolor , Umbral del Dolor , Humanos , Sensibilización del Sistema Nervioso Central/fisiología , Umbral del Dolor/fisiología , Dimensión del Dolor/métodos , Dolor/fisiopatología , Dolor/diagnósticoRESUMEN
BACKGROUND: Acceptance and Commitment Therapy (ACT) has been found to be beneficial for individuals dealing with chronic pain. The theoretical mechanisms of change proposed by ACT are based on the Hexaflex model. To comprehensively reflect this model, the Multidimensional Psychological Flexibility Inventory (MPFI) and Psy-Flex have been developed. The study aimed to adapt the MPFI-24 and the Psy-Flex for Spanish-speaking populations with chronic pain and to examine their dimensionality, internal consistency, convergent validity and incremental validity. METHODS: This cross-sectional study involved 309 Spanish-speaking adults with chronic pain who completed an online survey. The majority of the participants were women (88.3%). The ages ranged from 18 to 79 years. RESULTS: Factor analysis showed that the Spanish version of the MPFI-24 has 12 factors, consisting of six flexibility and six inflexibility factors, similar to the original version, but lacking second-order general factors. The Psy-Flex demonstrated a single-factor structure, maintaining the general factor of psychological flexibility seen in the original version. The MPFI-24 showed good internal consistency and adequate convergent validity, with the exception of the Acceptance and Experiential Avoidance subscales. The Psy-Flex showed good internal consistency and convergent validity. Notably, both the MPFI-24 and Psy-Flex scores significantly explained additional variance in psychological distress beyond other ACT-related measures of Hexaflex processes; however, only the Psy-Flex explained pain interference. CONCLUSIONS: The Spanish adaptations of the MPFI-24 and Psy-Flex are valid and reliable instruments for assessing the Hexaflex model processes in Spanish-speaking adults with chronic pain. SIGNIFICANCE STATEMENT: Practitioners and researchers in chronic pain will find the Spanish versions of the MPFI-24 and the Psy-Flex here, along with recommendations for their use and scoring based on a robust psychometric rationale. It should be noted that these measures surpass the Chronic Pain Acceptance Questionnaire (CPAQ) and the Psychological Inflexibility in Pain Scale (PIPS), which are considered gold standards in chronic pain assessment.
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Chronic pain and depression are frequently comorbid conditions associated with significant health care and social costs. This study examined the cost-utility and cost-effectiveness of videoconference-based group forms of Acceptance and Commitment Therapy (ACT) and Behavioral Activation Therapy for Depression (BATD), as a complement to treatment-as-usual (TAU), for patients with chronic low back pain (CLBP) plus depressive symptoms, compared to TAU alone. A trial-based economic evaluation (n = 234) was conducted from a governmental and health care perspective with a time horizon of 12 months. Primary outcomes were the Brief Pain Inventory-Interference Scale (BPI-IS) and Quality Adjusted Life Year. Compared to TAU, ACT achieved a significant reduction in total costs (d = .47), and BATD achieved significant reductions in indirect (d = .61) and total costs (d = .63). Significant improvements in BPI-IS (d = .73 and d = .66, respectively) and Quality Adjusted Life Year scores (d = .46 and d = .28, respectively) were found in ACT and BATD compared to TAU. No significant differences in costs and outcomes were found between ACT and BATD. In the intention-to-treat analyses, from the governmental and health care perspective, no significant differences in cost reduction and incremental effects were identified in the comparison between ACT, BATD, and TAU. However, in the complete case analysis, significant incremental effects of ACT (∆BPI-IS = -1.57 and -1.39, respectively) and BATD (∆BPI-IS = -1.08 and -1.04, respectively) compared with TAU were observed. In the per-protocol analysis, only the significant incremental effects of ACT (∆BPI-IS = -1.68 and -1.43, respectively) compared to TAU were detected. In conclusion, ACT and BATD might be efficient options in the management of CLBP plus comorbid depression symptoms as compared to usual care. However, no clear difference was found in the comparison between the 2 active therapies regarding cost-effectiveness or cost-utility. PERSPECTIVE: The economic evaluation of psychological therapies for the management of complex conditions can be used in decision-making and resource allocation. This study provides evidence that ACT and BATD are more effective and involve a greater reduction in costs than usual care in the management of CLBP plus comorbid depressive symptoms. TRIAL NUMBER: NCT04140838.
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Terapia de Aceptación y Compromiso , Dolor Crónico , Análisis Costo-Beneficio , Depresión , Dolor de la Región Lumbar , Comunicación por Videoconferencia , Humanos , Femenino , Masculino , Persona de Mediana Edad , Terapia de Aceptación y Compromiso/economía , Terapia de Aceptación y Compromiso/métodos , Dolor de la Región Lumbar/terapia , Dolor de la Región Lumbar/economía , Adulto , Comunicación por Videoconferencia/economía , Dolor Crónico/terapia , Dolor Crónico/economía , Depresión/terapia , Depresión/economía , Resultado del Tratamiento , Terapia Conductista/economía , Terapia Conductista/métodos , Comorbilidad , AncianoRESUMEN
Objective: Fibromyalgia (FM) is a prevalent pain syndrome with significant healthcare and societal costs. The aim of the SMART-FM-SP study is to determine the effectiveness, cost-utility, and physiological effects in patients with FM of a digital intervention (STANZA®) currently marketed in the United States, which delivers smartphone-based, fully self-guided Acceptance and Commitment Therapy (Digital ACT) for treating FM-related symptoms. Methods: A single-site, parallel-group, superiority, randomized controlled trial (RCT) will be conducted, including a total of 360 adults diagnosed with FM. Individuals will be randomly allocated (1:1:1) to treatment as usual (TAU), to TAU plus 12 weeks of treatment with Digital ACT, or to TAU plus 12 weeks of treatment with digital symptom tracking (i.e. FibroST). Participants will be assessed at baseline, post-treatment, and 6-month follow-up. An intention-to-treat analysis using linear mixed models will be computed to analyze the effects of Digital ACT on functional impairment (primary outcome), as measured by the Fibromyalgia Impact Questionnaire Revised at 6 months from the inception of the treatment. Secondary outcomes include impression of change, symptoms of distress, pain catastrophising, quality of life, cost-utility, and selected biomarkers (cortisol and cortisone, immune-inflammatory markers, and FKBP5 gene polymorphisms). The role of ACT-related processes of change will be tested with path analyses. Conclusions: This study is the first RCT that tests Digital ACT for Spanish patients with FM. Results will be important not only for patients and clinicians, but also for policy makers by examining the cost-utility of the app in a public healthcare context.
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Background: The growth of the prison population and the high recidivism rates of inmates represent a major public safety problem. Objective: This systematic review explored executive functions in inmates convicted of violent behavior compared with inmates convicted of non-violent behavior and healthy controls (HCs). Methods: Systematic searches were carried out using five databases (PubMed, Scopus, Web of Science, EBSCO, and Embase) until March 6th, 2023. Following Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, two reviewers independently performed the screening, data extraction, and risk of bias assessment of the 8 studies included. The protocol of this study was registered in Prospective Register of Systematic Reviews (PROSPERO), under registration number CRD42021252043. Results: Consistently, inmates convicted of violent behavior exhibited a greater alteration in inhibition than inmates convicted of non-violent behavior (four out of four studies) and HCs (two out of two studies). In addition, inmates convicted of violent behavior showed greater impairments in cognitive flexibility (two out of three studies) and working memory (two out of three studies) than HCs. Although with limited evidence (only one study), they also showed worse performance in set shifting and planning than HCs. Conclusion: This study provides evidence of alterations in inhibition in inmates convicted of violent behavior compared to inmates convicted of non-violent behavior and HCs. Even though inmates convicted of violent behavior showed greater impairments in planning and set shifting than HCs, these findings were supported in only one study. In general, more robust evidence is needed to confirm alterations in inmates convicted due to violent behavior. These findings highlight the importance of designing and promoting specific cognitive interventions that contribute to the reintegration of inmates into society. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021252043, identifier CRD42021252043.
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INTRODUCTION: Suicide is among the leading causes of preventable death worldwide. The impact of suicide affects the personal, social and economic levels. Therefore, its prevention is a priority for public health systems. Previous studies seem to support the efficacy of providing active contact to people who have made a suicide attempt. The current systematic review and meta-analysis aims to investigate the efficacy of distance suicide prevention strategies implemented through synchronous technology-based interventions. METHODS AND ANALYSIS: This protocol is designed according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. The bibliographical searches were conducted in the databases PubMed, PsycINFO, Scopus and Web of Science in April 2022, with no restrictions on the time of publication and limited to publications in English or Spanish. The search strategy was performed using free-text terms and Medical Subject Headings terms: suicide, follow-up, synchronous, remote, telehealth, telephone, hotline, video-conference and text message. Two reviewers will independently conduct study screening, selection process, data extraction and risk of bias assessment. The analysis and synthesis of the results will be both qualitative and quantitative. A narrative synthesis, presented in a comprehensive table, will be performed and meta-analysis will be conducted, as appropriate, if sufficient data are provided. ETHICS AND DISSEMINATION: The present review and meta-analysis will not require ethical approval, as it will use data collected from previously published primary studies. The findings of this review will be published in peer-reviewed journals and widely disseminated. PROSPERO REGISTRATION NUMBER: CRD42021275044.
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Ideación Suicida , Intento de Suicidio , Humanos , Revisiones Sistemáticas como Asunto , Metaanálisis como Asunto , Proyectos de Investigación , Literatura de Revisión como AsuntoRESUMEN
University students constitute a population that is highly vulnerable to developing mental health problems, such as distress. The role of different variables associated with the development of states of stress has been studied in order to identify potential risk and protective factors. This study explored whether mindfulness, self-compassion, and experiential avoidance, while controlling for specific sociodemographic and academic variables, were potential significant protective or risk factors explaining perceived stress in a sample of 589 Spanish university students (81.2% female, age range 18-48 years). A hierarchical multiple regression analysis was performed using an exploratory cross-sectional design. Higher experiential avoidance, lower self-compassion, lower mindfulness, not perceiving family support, higher total study hours per week, having a partner (vs. being single), being female (vs. being male), and being older were significantly associated with higher levels of perceived stress. In conclusion, perceived stress in our sample was positively associated with experiential avoidance, which could be regarded as a potential psychological risk variable. In contrast, perceived stress was negatively correlated with self-compassion and mindfulness, which, in turn, could be seen as protective factors. Accordingly, it is concluded that programmes aimed at reducing stress and at improving well-being among university students should include experiential avoidance, self-compassion, and mindfulness as therapeutic targets.
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Atención Plena , Humanos , Masculino , Femenino , Adolescente , Adulto Joven , Adulto , Persona de Mediana Edad , Autocompasión , Universidades , Estudios Transversales , Estrés Psicológico/psicología , Estudiantes/psicología , EmpatíaRESUMEN
Research on the use of Acceptance and Commitment Therapy (ACT) for patients with degenerative lumbar pathology awaiting surgery are limited. However, there is evidence to suggest that this psychological therapy may be effective in improving pain interference, anxiety, depression, and quality of life. This is the protocol for a randomized controlled trial (RCT) to evaluate the effectiveness of ACT compared to treatment as usual (TAU) for people with degenerative lumbar pathology who are candidates for surgery in the short term. A total of 102 patients with degenerative lumbar spine pathology will be randomly assigned to TAU (control group) or ACT + TAU (intervention group). Participants will be assessed after treatment and at 3-, 6-, and 12-month follow-ups. The primary outcome will be the mean change from baseline on the Brief Pain Inventory (pain interference). Secondary outcomes will include changes in pain intensity, anxiety, depression, pain catastrophizing, fear of movement, quality of life, disability due to low back pain (LBP), pain acceptance, and psychological inflexibility. Linear mixed models will be used to analyze the data. Additionally, effect sizes and number needed to treat (NNT) will be calculated. We posit that ACT may be used to help patients cope with the stress and uncertainty associated with their condition and the surgery itself.
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Objectives: The Toronto Mindfulness Scale (TMS) and the State Mindfulness Scale (SMS) are two relevant self-report measures of state mindfulness. The purpose of this study was to examine the internal structure and to offer evidence of the reliability and validity of the Spanish versions of the TMS and SMS. Methods: Data from six distinct non-clinical samples in Spain were obtained. They responded to the TMS (n = 119), SMS (n = 223), and measures of trait mindfulness, decentering, non-attachment, depression, anxiety, stress, positive and negative affect, self-criticism, and self-reassurance. The internal structure of the TMS and SMS was analyzed through confirmatory factor analysis. Reliability, construct validity, and sensitivity to change analyses were performed. Results: The correlated two-factor structure (curiosity and decentering) was the best-fitting model for the TMS (CFI = 0.932; TLI = 0.913; RMSEA = 0.100 [0.077-0.123]; WRMR = 0.908). The bifactor structure (general factor, mindfulness of body, and mindfulness of mind) was the best-fitting model for the SMS (CFI = 0.961; TLI = 0.950; RMSEA = 0.096 [0.086-0.106]; WRMR = 0.993). Adequate reliability was found for both measures. The reliability of the SMS specific factors was very poor when controlling for the general factor. The patterns of correlations were mainly as expected and according to previous literature. The TMS and SMS have been able to detect state mindfulness changes after different meditation practices. Conclusion: Validity evidence is provided to support the use of the TMS and SMS in Spanish populations, though the reliability of the SMS specific factors merit revision.
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BACKGROUND: The Community Attitudes to Mental Illness (CAMI) scale measures social stigma towards people with mental illness. Although it has been used worldwide, the psychometric properties of the CAMI have not been systematically reviewed. The main aim of this study was to systematically review the psychometric properties of the different versions of the CAMI more than 40 years after of its publication. METHODS: A systematic search was conducted in MEDLINE, PsycINFO, Web of Science, and EMBASE from 1981 (year of publication) to 2023 (present). A double review was performed for eligibility, data extraction, and quality assessment. RESULTS: A total of 15 studies enrolling 10,841 participants were included. The most frequently reported factor structure comprises 3 or 4 factors. Overall, the internal consistency seems adequate for the global scale (α ≥ 0.80), except for CAMI-10 (α = 0.69). Internal consistency of the subscales are not supported, with authoritarianism being the weakest factor (α = 0.27 to 0.68). The stability over time of the total scale has been assessed in the CAMI-40, CAMI-BR, and CAMI-10 (r ≥ 0.39). Few studies have assessed the temporal stability of the CAMI subscales. Most of the correlations with potentially related measures are significant and in the expected direction. CONCLUSIONS: The 3 and 4 factor structure are the most widely reported in the different versions of the CAMI. Even though reliability and construct validity are acceptable, further item refinement by international consensus seems warranted more than 40 years after the original publication. SYSTEMATIC REVIEW REGISTRATION: PROSPERO identification number: CRD42018098956.
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Trastornos Mentales , Estigma Social , Humanos , Psicometría , Reproducibilidad de los Resultados , Encuestas y CuestionariosRESUMEN
This study examined the efficacy of adding a remote, synchronous, group, videoconference-based form of acceptance and commitment therapy (ACT) or behavioral activation therapy for depression (BATD) to treatment-as-usual (TAU) in 234 patients with chronic low back pain (CLBP) plus comorbid depressive symptoms. Participants were randomly assigned to ACT, BATD, or TAU. Compared to TAU, ACT produced a significant reduction in pain interference at posttreatment (d = .64) and at follow-up (d = .73). BATD was only superior to TAU at follow-up (d = .66). A significant reduction in pain catastrophizing was reported by patients assigned to ACT and BATD at posttreatment (d = .45 and d = .59, respectively) and at follow-up (d = .59, in both) compared to TAU. Stress was significantly reduced at posttreatment by ACT in comparison to TAU (d = .69). No significant between-group differences were found in depressive or anxiety symptoms. Clinically relevant number needed to treat (NNT) values for reduction in pain interference were obtained at posttreatment (ACT vs TAU = 4) and at follow-up (ACT vs TAU = 3; BATD vs TAU = 5). In both active therapies, improvements in pain interference at follow-up were significantly related to improvements at posttreatment in psychological flexibility. These findings suggest that new forms of cognitive-behavioral therapy are clinically useful in improving pain interference and pain catastrophizing. Further research on evidence-based change processes is required to understand the therapeutic needs of patients with chronic pain and comorbid conditions. TRIAL NUMBER: NCT04140838. PERSPECTIVE: Group videoconference-based ACT and BATD showed greater efficacy than TAU for reducing pain interference and pain catastrophizing in patients with CLBP plus clinically relevant depression. Psychological flexibility appeared to be the main contributor to treatment effects for both ACT and BATD.
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Terapia de Aceptación y Compromiso , Dolor Crónico , Dolor de la Región Lumbar , Humanos , Depresión/terapia , Dolor de la Región Lumbar/terapia , Resultado del Tratamiento , Terapia Conductista , Dolor Crónico/terapia , Dolor Crónico/psicologíaRESUMEN
PURPOSE: To explore the experiences of patients with chronic low back pain (CLBP) plus comorbid depressive symptoms who received a remote synchronous videoconference group form of Acceptance and Commitment Therapy (ACT) or Behavioral Activation Treatment for Depression (BATD). METHODS: A qualitative study (IMPACT-Q) was nested within a randomized controlled trial (RCT) designed to assess the efficacy and the cost-utility/cost-effectiveness of two therapies in the management of CLBP and depression. Fifty-five patients with CLBP plus depression were selected from the RCT. Twelve focus group sessions, each approximately 60-90 min long, were audio-recorded, transcribed verbatim, and analyzed by six coders through a thematic analysis (deductive and inductive) based on a descriptive phenomenological approach. RESULTS: Patients perceived behavioral, affective, and cognitive improvements after completing group sessions. Overall, psychotherapy was perceived as a safe and non-judgmental place to express emotions and feel understood. The main barriers reported were lack of human contact and loss of social interaction. In contrast, ease of access, flexibility in the ability to connect from anywhere, avoidance of the need to travel, and savings in time and money were key facilitators to increase attendance and adherence to therapy. CONCLUSION: This study provided support for the acceptability of videoconference-delivered ACT or BATD in patients with CLBP plus comorbid depressive symptoms.
Overall, patients reported behavioral, affective, and cognitive improvements after Acceptance and Commitment Therapy and Behavioral Activation Treatment for Depression group sessions.Acceptance and Commitment Therapy and Behavioral Activation Treatment for Depression delivered via videoconference platform were perceived as a facilitator for therapy attendance rather than a barrier.The findings indicate that group therapy on videoconferencing is perceived favorably as an alternative for managing patients with chronic pain and comorbid depression.Technical and social aspects of implementing videoconferencing therapies should be improved, as well as guidelines for adequate support for patients and therapists should also be provided.
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Objective: Chronic pain frequently co-occurs with clinically relevant psychological distress. A systematic review was conducted to identify the efficacy of cognitive behavioral therapy-based interventions for patients with these comorbid conditions. Methods: The systematic search was carried out in Medline, PsycINFO, Web of Science, and Scopus up to March 18th, 2023. Four reviewers independently conducted screenings, extraction, and quality assessment. Results: Twelve randomized controlled trials and one non-randomized controlled trial involving 1,661 participants that examined the efficacy of Cognitive Behavioral Therapy (nine studies), Mindfulness-based Interventions (three studies), Acceptance and Commitment Therapy (one study), and Behavioral Activation Therapy for Depression (one study) were included. Compared to treatment as usual, six out of eight studies of traditional Cognitive Behavioral Therapy reported significant differences in the reduction of depressive symptoms at post-treatment (d from 1.31 to 0.18) and four out of six at follow-up (d from 0.75 to 0.26); similarly, five out of six reported significant differences in the reduction of anxiety symptoms at post-treatment (d from 1.08 to 0.19) and three out of four at follow-up (d from 1.07 to 0.27). Overall, no significant differences between traditional Cognitive Behavioral Therapy and treatment as usual were reported at post-treatment and follow-up in the studies exploring pain intensity and pain catastrophizing. Conclusion: The available evidence suggests that traditional Cognitive Behavioral Therapy may produce significant benefits for the improvement of depression, anxiety, and quality of life, but not for pain intensity and pain catastrophizing. More evidence is needed to determine the effects of MBI, ACT, and BATD. Systematic review registration: PROSPERO, CRD42021219921.
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This systematic review aimed to investigate immune-inflammatory and hypothalamic-pituitary-adrenal (HPA) axis biomarkers in individuals with non-specific low back pain (NSLBP) compared to healthy control. The search was performed in five databases until 4 November 2021. Two reviewers independently conducted screenings, data extraction, risk of bias, and methodological quality assessment of 14 unique studies. All studies reported the source of the fluid analyzed: nine studies used serum, two used plasma, one used serum and plasma, and two studies used salivary cortisol. We found preliminary and limited evidence (only one study for each biomarker) of increased levels in growth differentiation factor 15 (GDF-15), interleukin-23 (IL-23), transforming growth factor-beta (TGF-ß), and soluble tumor necrosis factor receptor 1 (sTNF-R1) in NSLBP. Inconsistent and limited evidence was identified for interleukin-10 (IL-10). Although C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) levels appear to increase in NSLBP, only one study per each biomarker reported statistically significant differences. Interleukin-1 beta (IL-1ß), interleukin-17 (IL-17), interferon gamma (IFN-γ), and high-sensitivity CRP (hsCRP) showed no significant differences. Regarding cortisol, one study showed a significant increase and another a significant decrease. More robust evidence between GDF-15, IL-23, TGF-ß, and sTNF-R1 with NSLBP is needed. Moreover, contrary to the findings reported in previous studies, when comparing results exclusively with healthy control, insufficient robust evidence for IL-6, TNF-α, and CRP was found in NSLBP. In addition, cortisol response (HPA-related biomarker) showed a dysregulated functioning in NSLBP, with incongruent evidence regarding its directionality. Therefore, our effort is to find adjusted evidence to conclude which immune-inflammatory and HPA axis biomarkers are altered in NSLBP and how much their levels are affected. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020176153, identifier CRD42020176153.
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Dolor de la Región Lumbar , Sistema Hipófiso-Suprarrenal , Biomarcadores , Proteína C-Reactiva/metabolismo , Factor 15 de Diferenciación de Crecimiento/metabolismo , Humanos , Hidrocortisona , Sistema Hipotálamo-Hipofisario/metabolismo , Interferón gamma/metabolismo , Interleucina-10/metabolismo , Interleucina-17/metabolismo , Interleucina-1beta/metabolismo , Interleucina-23/metabolismo , Interleucina-6/metabolismo , Dolor de la Región Lumbar/diagnóstico , Sistema Hipófiso-Suprarrenal/metabolismo , Receptores del Factor de Necrosis Tumoral/metabolismo , Factor de Crecimiento Transformador beta/metabolismo , Factores de Crecimiento Transformadores/metabolismo , Factor de Necrosis Tumoral alfa/metabolismoRESUMEN
INTRODUCTION: There is evidence that low-dose naltrexone (LDN; <5.0 mg/day) reduces pain and improves the quality of life of people with fibromyalgia syndrome (FMS). However, no randomised controlled trials with long-term follow-ups have been carried out. The INNOVA study will evaluate the add-on efficacy, safety, cost-utility and neurobiological effects of LDN for reducing pain in patients with FMS, with a 1-year follow-up. METHODS AND ANALYSIS: A single-site, prospective, randomised, double-blinded, placebo-controlled, parallel design phase III trial will be performed. Eligibility criteria include being adult, having a diagnosis of FMS and experiencing pain of 4 or higher on a 10-point numerical rating scale. Participants will be randomised to a LDN intervention group (4.5 mg/day) or to a placebo control group. Clinical assessments will be performed at baseline (T0), 3 months (T1), 6 months (T2) and 12 months (T3). The primary endpoint will be pain intensity. A sample size of 60 patients per study arm (120 in total), as calculated prior to recruitment for sufficient power, will be monitored between January 2022 and August 2024. Assessment will also include daily ecological momentary evaluations of FMS-related symptoms (eg, pain intensity, fatigue and sleep disturbance), and side effects via ecological momentary assessment through the Pain Monitor app during the first 3 months. Costs and quality-adjusted life years will be also calculated. Half of the participants in each arm will be scanned with MRI at T0 and T1 for changes in brain metabolites related to neuroinflammation and central sensitisation. Inflammatory biomarkers in serum will also be measured. ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee of the Fundació Sant Joan de Déu. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and community engagement activities. TRIAL REGISTRATION NUMBER: NCT04739995.
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Fibromialgia , Naltrexona , Adulto , Ensayos Clínicos Fase III como Asunto , Método Doble Ciego , Fibromialgia/tratamiento farmacológico , Humanos , Naltrexona/uso terapéutico , Estudios Prospectivos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
OBJECTIVE: The purpose of this study was to evaluate the effectiveness of a 12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness-in addition to treatment as usual-compared with treatment as usual only in patients with fibromyalgia. METHODS: This randomized controlled trial involved a total of 272 patients who were randomly assigned to either multicomponent treatment (n = 135) or treatment as usual (n = 137). The multicomponent treatment (2-hour weekly sessions) was delivered in groups of 20 participants. Treatment as usual was mainly based on pharmacological treatment according to the predominant symptoms. Data on functional impairment using the Revised Fibromyalgia Impact Questionnaire as the primary outcome were collected as were data for pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) at baseline, 12 weeks, and, for the multicomponent group only, 6 and 9 months. An intention-to-treat approach was used to analyze between-group differences. Baseline differences between responders (>20% Revised Fibromyalgia Impact Questionnaire reduction) and nonresponders also were analyzed, and the number needed to treat was computed. RESULTS: At posttreatment, significant between-group differences with a large effect size (Cohen d > 0.80) in favor of the multicomponent treatment were found in functional impairment, pain, kinesiophobia, and physical function, whereas differences with a moderate size effect (Cohen d > 0.50 and <0.80) were found in fatigue, anxiety, and depressive symptoms. Nonresponders scored higher on depressive symptoms than responders at baseline. The number needed to treat was 2 (95% CI = 1.7-2.3). CONCLUSION: Compared with usual care, there was evidence of short-term (up to 3 months) positive effects of the multicomponent treatment for fibromyalgia. Some methodological shortcomings (eg, absence of follow-up in the control group and monitoring of treatment adherence, potential research allegiance) preclude robust conclusions regarding the proposed multicomponent program. IMPACT: Despite some methodological shortcomings in the design of this study, the multicomponent therapy FIBROWALK can be considered a novel and effective treatment for patients with fibromyalgia. Physical therapists should detect patients with clinically relevant depression levels prior to treatment because depression can buffer treatment effects. LAY SUMMARY: Fibromyalgia is prevalent and can be expensive to treat. This multicomponent treatment could significantly improve the core symptoms of fibromyalgia compared with usual treatment.
Asunto(s)
Terapia Cognitivo-Conductual/métodos , Terapia por Ejercicio/métodos , Fibromialgia/psicología , Fibromialgia/terapia , Atención Plena/métodos , Terapia Combinada , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
The identification of general population groups particularly vulnerable to the impact of COVID-19 lockdown measures on mental health and the development of healthcare policies are priority challenges in the current and future pandemics. This study aimed to identify the personal and social determinants of the impact of COVID-19 lockdown measures on mental health in a large sample of the Colombian population. In this cross-sectional study, an anonymous online survey was answered by 18,061 participants from the general population residing in Colombia during the first wave of the COVID-19 outbreak (from 20 May to 20 June 2020). The risk of depression, anxiety, and somatization disorders were measured using the Patient Health Questionnaire (PHQ-2), Generalized Anxiety Disorder Scale (GAD-2), and Somatic Symptom Questionnaire (SSQ-5), respectively. Overall, 35% of participants showed risk of depression, 29% of anxiety, and 31% of somatization. According to the analysis of social determinants of health, the most affected groups were people with low incomes, students, and young adults (18-29 years). Specifically, low-income young females were the most at-risk population group. These findings show how the lockdown measures affected the general population's mental health in Colombia and highlight some social risk factors in health.
RESUMEN
The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.