Is the Central Sensitization Inventory (CSI) associated with quantitative sensory testing (QST)? A systematic review and meta-analysis.

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.

Study protocol for a three-arm randomized controlled trial investigating the effectiveness, cost-utility, and physiological effects of a fully self-guided digital Acceptance and Commitment Therapy for Spanish patients with fibromyalgia.

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.

Economic Evaluation of Videoconference Group Acceptance and Commitment Therapy and Behavioral Activation Therapy for Depression Versus Usual Care Among Adults With Chronic Low Back Pain Plus Comorbid Depressive Symptoms.

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.

A Systematic Review of the Psychometric Properties of the Patient Health Questionnaire-4 in Clinical and Nonclinical Populations.

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.

Effect of synchronous remote-based interventions on suicidal behaviours: protocol for a systematic review and meta-analysis.

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.

Experiences of patients with chronic low back pain plus comorbid depressive symptoms in a videoconference group acceptance and commitment therapy or behavioral activation treatment for depression: a qualitative study.

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.

Alterations in executive functions in inmates convicted for violent behavior: a systematic review.

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.

The Toronto Mindfulness Scale and the State Mindfulness Scale: psychometric properties of the Spanish versions.

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.

Effectiveness of Acceptance and Commitment Therapy (ACT) for the Management of Postsurgical Pain: Study Protocol of a Randomized Controlled Trial (SPINE-ACT Study).

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.

Over 40 years (1981-2023) assessing stigma with the Community Attitudes to Mental Illness (CAMI) scale: a systematic review of its psychometric properties.

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.

Efficacy of Videoconference Group Acceptance and Commitment Therapy (ACT) and Behavioral Activation Therapy for Depression (BATD) for Chronic Low Back Pain (CLBP) Plus Comorbid Depressive Symptoms: A Randomized Controlled Trial (IMPACT Study).

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.

How mindfulness, self-compassion, and experiential avoidance are related to perceived stress in a sample of university students.

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.

A systematic review of cognitive behavioral therapy-based interventions for comorbid chronic pain and clinically relevant psychological distress.

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.

Immune-inflammatory and hypothalamic-pituitary-adrenal axis biomarkers are altered in patients with non-specific low back pain: A systematic review.

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.

Study protocol for a randomised, double-blinded, placebo-controlled phase III trial examining the add-on efficacy, cost-utility and neurobiological effects of low-dose naltrexone (LDN) in patients with fibromyalgia (INNOVA study).

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.

Social Inequities in the Impact of COVID-19 Lockdown Measures on the Mental Health of a Large Sample of the Colombian Population (PSY-COVID Study).

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.

Effectiveness of a Multicomponent Treatment Based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioral Therapy, and Mindfulness in Patients With Fibromyalgia (FIBROWALK Study): A Randomized Controlled Trial.

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.

Effectiveness of a Multicomponent Treatment for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): A Pragmatic Randomized Controlled Trial.

A recent study (FIBROWALK has supported the effectiveness of a multicomponent treatment based on pain neuroscience education (PNE), exercise therapy (TE), cognitive behavioral therapy (CBT), and mindfulness in patients with fibromyalgia. The aim of the present RCT was: (a) to analyze the effectiveness of a 12-week multicomponent treatment (nature activity therapy for fibromyalgia, NAT-FM) based on the same therapeutic components described above plus nature exposure to maximize improvements in functional impairment (primary outcome), as well as pain, fatigue, anxiety-depression, physical functioning, positive and negative affect, self-esteem, and perceived stress (secondary outcomes), and kinesiophobia, pain catastrophizing thoughts, personal perceived competence, and cognitive emotion regulation (process variables) compared with treatment as usual (TAU); (b) to preliminarily assess the effects of the nature-based activities included (yoga, Nordic walking, nature photography, and Shinrin Yoku); and (c) to examine whether the positive effects of TAU + NAT-FM on primary and secondary outcomes at post-treatment were mediated through baseline to six-week changes in process variables. A total of 169 FM patients were randomized into two study arms: TAU + NAT-FM vs. TAU alone. Data were collected at baseline, at six-week of treatment, at post-treatment, and throughout treatment by ecological momentary assessment (EMA). Using an intention to treat (ITT) approach, linear mixed-effects models and mediational models through path analyses were computed. Overall, TAU + NAT-FM was significantly more effective than TAU at posttreatment for the primary and secondary outcomes evaluated, as well as for the process variables. Moderate-to-large effect sizes were achieved at six-weeks for functional impairment, anxiety, kinesiophobia, perceived competence, and positive reappraisal. The number needed to treat (NNT) was 3 (95%CI = 1.6-3.2). The nature activities yielded an improvement in affective valence, arousal, dominance, fatigue, pain, stress, and self-efficacy. Kinesiophobia and perceived competence were the mediators that could explain a significant part of the improvements obtained with TAU + NAT-FM treatment. TAU + NAT-FM is an effective co-adjuvant multicomponent treatment for improving FM-related symptoms.

Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial.

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.

Testing the Intermediary Role of Perceived Stress in the Relationship between Mindfulness and Burnout Subtypes in a Large Sample of Spanish University Students.

The burnout syndrome is the consequence of chronic stress that overwhelms an individual's resources to cope with occupational or academic demands. Frenetic, under-challenged, and worn-out are different burnout subtypes. Mindfulness has been recognized to reduce stress, comprising five facets (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience). This cross-sectional study aimed to assess the relationship between mindfulness facets, perceived stress, and burnout subtypes in a sample of 1233 students of Education, Nursing, and Psychology degrees from different universities of Valencia (Spain). Structural Equation Modelling (SEM) was computed showing an adequate fit (Chi-square, CFI, TLI, RMSEA, and SRMR). Four mindfulness facets (all but observing) significantly correlated with general second-order mindfulness. Unexpected results were found: Acting with awareness facet was positively associated with frenetic subtype, while the non-reacting facet was positively associated with frenetic and under-challenged subtype. Ultimately, mindfulness facets negatively predicted the perceived stress levels, which in turn, predicted burnout. However, mindfulness plays different roles in the early stages of burnout syndrome (i.e., frenetic and under-challenged).