Affective disorders: eliminate WArning signs And REstore functioning: AWARE. Results from a randomized controlled multimodular intervention study targeting functioning in patients with affective disorders.

BACKGROUND: There is a compelling need for innovative intervention strategies for patients with affective disorders, given their increasing global prevalence and significant associated disability and impaired functioning. This study aimed to investigate whether a comprehensive multimodule individualized intervention (AWARE), targeting known mediators of functioning, improves functioning in affective disorders. METHODS: AWARE was a randomized, controlled, rater-blind clinical trial conducted at two centers in the Capital Region of Denmark (Clinicaltrials.gov, NCT04701827). Participants were adults with bipolar disorder or major depressive disorder and impaired functioning. Participants were randomized to the six-month AWARE intervention or treatment as usual (TAU). The AWARE intervention is based on the International Classification of Functioning, Disability and Health (ICF) Brief Core Set for Bipolar and Unipolar Disorder.The primary outcome was observation-based functioning using the Assessment of Motor and Process Skills (AMPS). Secondary outcomes were functioning, QoL, stress, and cognition. RESULTS: Between February 2021 and January 2023, 103 patients were enrolled; 50 allocated to AWARE treatment and 53 to TAU (96 included in the full analysis set). There was no statistically significant differential change over time between groups in the primary outcome (AMPS), however, both groups showed a statistically significant improvement at endpoint. The AWARE intervention had a statistically significant effect compared with TAU on secondary outcomes of patient-reported functioning, stress and cognition. CONCLUSION: Compared with TAU, the AWARE intervention was ineffective at improving overall functioning on the primary outcome, presumably due to the short duration of the intervention. Further development of effective treatments targeting functioning is needed.

A randomised controlled intervention trial to study the effect of a personalised lifestyle programme on cancer-related fatigue among colorectal cancer survivors: protocol for the SoFiT study.

Observational studies suggest that a healthy diet in combination with ample physical activity is associated with a lower prevalence of cancer-related fatigue. The SoFiT trial (SoFiT: Study on Fatigue: a lifestyle intervention among colorectal cancer survivors) will assess the effect of a personalised lifestyle programme on cancer-related fatigue in a randomised study. We designed a programme that aims to increase adherence to lifestyle recommendations on diet and physical activity. The programme was person-centred with regard to the lifestyle and personal characteristics of participants, to the determinants of behaviour of that participant, and to the preferences, opportunities and barriers of the participant. The effect of the programme was tested in the SoFiT trial: a two-armed, parallel, randomised controlled trial among adult stage I-III colorectal cancer survivors, who experience cancer-related fatigue after treatment completion; intended sample size n=184. Participants randomised to the intervention group received the personalised lifestyle programme. During 6 months, participants in the intervention group had individual sessions with a lifestyle coach of which four sessions were face-to-face and eight sessions were remote. After 6 months, participants randomised to the control group had access to two lifestyle coaching sessions and to the same materials that the intervention group also received. The primary endpoint of the trial is cancer-related fatigue. Secondary endpoints are sleep quality and duration, health-related quality of life, physical performance, depression and anxiety, skeletal muscle echo intensity and cross-sectional area, and gut microbiota composition. This trial will show the effects of a personalised lifestyle programme on cancer-related fatigue and on an extensive set of secondary outcomes. Clinicaltrials.gov: NCT05390398.

Preparing for colorectal surgery: a feasibility study of a novel web-based multimodal prehabilitation programme in Western Canada.

AIM: Prehabilitation for colorectal cancer has focused on exercise-based interventions that are typically designed by clinicians; however, no research has yet been patient-oriented. The aim of this feasibility study was to test a web-based multimodal prehabilitation intervention (known as PREP prehab) consisting of four components (physical activity, diet, smoking cessation, psychological support) co-designed with five patient partners. METHOD: A longitudinal, two-armed (website without or with coaching support) feasibility study of 33 patients scheduled for colorectal surgery 2 weeks or more from consent (January-September 2021) in the province of British Columbia, Canada. Descriptive statistics analysed a health-related quality of life questionnaire (EQ5D-5L) at baseline (n = 25) and 3 months postsurgery (n = 21), and a follow-up patient satisfaction survey to determine the acceptability, practicality, demand for and potential efficacy in improving overall health. RESULTS: Patients had a mean age of 52 years (SD 14 years), 52% were female and they had a mean body mass index of 25 kg m-2 (SD 3.8 kg m-2). Only six patients received a Subjective Global Assessment for being at risk for malnutrition, with three classified as 'severely/moderately' malnourished. The majority (86%) of patients intended to use the prehabilitation website, and nearly three-quarters (71%) visited the website while waiting for surgery. The majority (76%) reported that information, tools and resources provided appropriate support, and 76% indicated they would recommend the PREP prehab programme. About three-quarters (76%) reported setting goals for lifestyle modification: 86% set healthy eating goals, 81% aimed to stay active and 57% sought to reduce stress once a week or more. No patients contacted the team to obtain health coaching, despite broad interest (71%) in receiving active support and 14% reporting they received 'active support'. CONCLUSION: This web-based multimodal prehabilitation programme was acceptable, practical and well-received by all colorectal surgery patients who viewed the patient-oriented multimodal website. The feasibility of providing active health coaching support requires further investigation.

Response rates and associated factors after a multicomponent intervention in frail older adults with diabetes.

BACKGROUND: Type 2 diabetes mellitus (T2DM) and frailty are associated with functional decline in older population. OBJECTIVE: To explore the individual response to a multimodal intervention on functional performance. DESIGN: A cluster-randomised multicentre clinical trial. SETTING: Outpatients in hospital or primary care. SUBJECTS: 843 (77.83 years, 50.65% men) prefrail and frail individuals ≥70 years with T2DM. METHODS: Participants were allocated to usual care group (UCG) or a multicomponent intervention group (IG): 16-week progressive resistance training, seven nutritional and diabetological educational sessions and achievement of glycated haemoglobin (7-8%) and blood pressure (<150 mmHg) targets. Functional performance was assessed with the Short Physical Performance Battery (SPPB) at 1 year. We used multivariate binomial and multinomial logistic regression models to explore the effect of the IG, and adherence on the outcomes studied, in several adjusted models. RESULTS: 53.7% in the IG versus 38.0% in the UCG improved by at least 1 point in their SPPB score [OR (95% CI): 2.07 (1.43, 2.98), P value <0.001]. Age, SPPB score and number of frailty criteria met decreased the probability of improving the SPPB score. Factors associated with worsening were pertaining to IG (decreased), age, SPPB score and the number of frailty criteria (increased). An adherence ≥84% was needed to achieve benefits, reaching the peak in the probability of improving SPPB when this was ≥85% [OR(95%CI): 2.38 (1.29, 4.79), P value 0.014]. CONCLUSIONS: Factors predicting the likelihood of improvement in a multimodal programme in pre-frail and frail older adults with diabetes are age, basal SPPB score, the number of frailty criteria and adherence.

Does a multimodal prehabilitation program improve sleep quality and duration in patients undergoing colorectal resection for cancer? Pilot randomized control trial.

Sleep difficulties are a common symptom in cancer patients at different stages of treatment trajectory and may lead to numerous negative consequences for which management is required. This pilot Randomized Controlled Trial (RCT) aims to assess the potential effectiveness of home-based prehabilitation intervention (prehab) on sleep quality and parameters compared to standard care (SOC) in colorectal cancer patients during the preoperative period and up to 8 weeks after the surgery. One hundred two participants (48.3% female, mean age 65 years) scheduled for elective resection of colorectal cancer were randomized to the prehab (n = 50) or the SOC (n = 52) groups. Recruitment and retention rates were 54% and 72%, respectively. Measures were completed at the baseline and preoperative, 4- and 8-week after-surgery follow-ups. Our mixed models' analyses revealed no significant differences between groups observed over time for all subjective and objective sleep parameters. A small positive change was observed in the perceived sleep quality only at the preoperative time point for the prehabilitation group compared to the SOC group, with an effect size d = 0.11 and a confidence interval (CI) between - 2.1 and - 0.1, p = .048. Prehab group patients with high anxiety showed a significant improvement in the rate of change of sleep duration over time compared to the SOC group, with a difference of 110 min between baseline and 8 weeks after surgery (d = 0.51, 95% CI: 92.3 to 127.7, p = .02). Multimodal prehabilitation intervention is feasible in colorectal cancer patients and may improve sleep duration for patients with high anxiety symptoms. Future large-scale RCTs are needed to confirm our results.

eHealth-Integrated Psychosocial and Physical Interventions for Chronic Pain in Older Adults: Scoping Review.

BACKGROUND: Chronic noncancer pain (CNCP) is highly present among older adults, affecting their physical, psychological, and social functioning. A biopsychosocial multimodal approach to CNCP management is currently extensively suggested by international clinical practice guidelines. Recently, the growing development and application of eHealth within pain management has yielded encouraging results in terms of effectiveness and feasibility; however, its use among the older population remains underexamined. OBJECTIVE: The overall aim of this scoping review was to systematically map existing literature about eHealth multimodal interventions (including both physical and psychosocial components) targeting older adults with CNCP. METHODS: This review adhered to the JBI methodology, a protocol was a priori registered as a preprint on the medRxiv platform, and the results were reported according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Four electronic databases (PubMed, Cochrane Central Register of Controlled Trials, Web of Science, and PsycINFO) were systematically searched for relevant articles. Studies were included if they reported on multimodal interventions (including both physical and psychosocial components) delivered through any eHealth modality to an older population with any type of CNCP. Two reviewers selected the studies: first by screening titles and abstracts and second by screening full-text articles. The quality of the included studies was evaluated using the Quality Assessment Tool for Studies with Diverse Designs. The results of the studies were summarized narratively. RESULTS: A total of 9 studies (n=6, 67% published between 2021 and 2023) with quality rated as medium to high were included, of which 7 (78%) were randomized controlled trials (n=5, 71% were pilot and feasibility studies). All the included studies evaluated self-management interventions, most of them (n=7, 78%) specifically designed for older adults. The participants were aged between 65 and 75 years on average (mean 68.5, SD 3.5 y) and had been diagnosed with different types of CNCP (eg, osteoarthritis and chronic low back pain). Most of the included studies (5/9, 56%) involved the use of multiple eHealth modalities, with a higher use of web-based programs and video consulting. Only 1 (11%) of the 9 studies involved a virtual reality-based intervention. The evaluated interventions showed signs of effectiveness in the targeted biopsychosocial outcomes, and the participants' engagement and ratings of satisfaction were generally positive. However, several research gaps were identified and discussed. CONCLUSIONS: Overall, of late, there has been a growing interest in the potential that eHealth multimodal interventions offer in terms of improving pain, physical, and psychosocial outcomes in older adults with CNCP. However, existing literature on this topic still seems scarce and highly heterogeneous, with few proper randomized controlled trials, precluding robust conclusions. Several gaps emerged in terms of the older population considered and the lack of evaluation of comorbidities. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1101/2023.07.27.23293235.

The Effects of a Complex Interactive Multimodal Intervention on Personalized Stress Management Among Health Care Workers in China: Nonrandomized Controlled Study.

BACKGROUND: Health care workers (HCWs) frequently face multiple stressors at work, particularly those working night shifts. HCWs who have experienced distress may find it difficult to adopt stress management approaches, even if they are aware of the effects of stress and coping processes. Therefore, an individualized intervention may be required to assist distressed HCWs in bridging the "knowledge-practice" gap in stress management and effectively alleviating stress symptoms. OBJECTIVE: The main objective of this research was to compare the effects of a complex interactive multimodal intervention (CIMI) to self-guided stress management interventions on stress symptoms of distressed HCWs, as measured by physiological (heart rate variability), psychological (perceived stress, mental distress, and subjective happiness), and sleep disorder (fatigue and sleepiness) indicators. METHODS: We conducted a nonrandomized, controlled study in 2 Chinese general hospitals. The participants in this study were 245 HCWs who fulfilled at least 1 of the 3 dimensions on the Depression, Anxiety, and Stress Scale. All eligible individuals were required to complete a questionnaire and wear a 24-hour Holter device to determine the physiological signs of stress as indexed by heart rate variability at both baseline and after the intervention. The CIMI group received a 12-week online intervention with 4 components-mobile stress management instruction, a web-based WeChat social network, personalized feedback, and a nurse coach, whereas the control group simply received a self-guided intervention. RESULTS: After a 12-week intervention, the Perceived Stress Scale (PSS) scores reduced significantly in the CIMI group (mean difference [MD] -5.31, 95% CI -6.26 to -4.37; P<.001) compared to the baseline levels. The changes in PSS scores before and after the intervention exhibited a significant difference between the CIMI and control groups (d=-0.64; MD -4.03, 95% CI -5.91 to -2.14; P<.001), and the effect was medium. In terms of physiological measures, both the control group (MD -9.56, 95% CI -16.9 to -2.2; P=.01) and the CIMI group (MD -8.45, 95% CI -12.68 to -4.22; P<.001) demonstrated a significant decrease in the standard deviation of normal-to-normal intervals (SDNN) within the normal clinical range; however, there were no significant differences between the 2 groups (d=0.03; MD 1.11, 95% CI -7.38 to 9.59; P=.80). CONCLUSIONS: The CIMI was an effective intervention for improving sleep disorders, as well as parts of the psychological stress measures in distressed HCWs. The findings provide objective evidence for developing a mobile stress management intervention that is adaptable and accessible to distressed HCWs, but its long-term effects should be investigated in future research. TRIAL REGISTRATION: ClinicalTrials.gov NCT05239065; https://clinicaltrials.gov/ct2/show/NCT05239065.

Mediators during a Multimodal intervention for stress-induced exhaustion disorder.

Our understanding of the underlying psychological processes of development, maintenance, and treatments for stress-induced exhaustion disorder (ED) remains limited. Therefore, the current study aimed to explore whether sleep concerns, pathological worry, perfectionistic concerns, and psychological flexibility mediate change in exhaustion symptoms during a Multimodal intervention for ED based on Cognitive behavioral therapy principles. Participants (N = 913) were assessed at three time points, and mediation was explored using a two-criteria analytical model with linear mixed-effects models (criterion one) and random intercepts cross-lagged panel modeling (criterion 2). Criterion one for mediation was successfully met, as the findings indicated significant associations between time in treatment, with all suggested mediators, and exhaustion symptoms (significant ab-products). However, criterion two was not satisfied as changes in the mediators did not precede changes in exhaustion symptoms. Therefore, mediation could not be established. Instead, changes in the suggested mediators appeared to result from changes in exhaustion symptoms. Consequently, sleep concerns, pathological worry, perfectionistic concerns, and psychological flexibility appear to improve in conjunction with exhaustion symptoms during treatment, where improvement in exhaustion is indicated as the main driving factor, based on this exploratory analysis. The implications of these findings are contextualized within a broader framework of process-based therapy.

An 18-month multimodal intervention trial for preventing dementia: J-MINT PRIME Tamba.

BACKGROUND: The number of people with dementia is increasing in Japan, and establishing evidence for preventing dementia is necessary. METHODS: This study was a randomized controlled trial in cognitively normal community-dwelling older adults aged 65 to 85 with diabetes and/or hypertension. Participants were randomly assigned in a 1:1 ratio. The intervention group underwent 90 min of group-based weekly physical exercise, cognitive training, nutritional counseling, and vascular risk management for 18 months. The primary endpoint was the change in a cognitive composite score calculated by averaging the z-scores of seven neuropsychological tests from baseline to 18 months. RESULTS: We randomly assigned 203 participants to two groups, and 178 (87.7%) completed the 18-month follow-up. There was a significant group difference in the cognitive composite score change at 18 months (mean difference 0.16, 95% confidence interval: 0.04 to 0.27; p = 0.009). DISCUSSION: An 18-month multimodal intervention for older adults at risk of dementia could improve their cognitive function. The trial was registered in the Clinical Trial Registration System (UMIN000041938). HIGHLIGHTS: Japan-Multimodal Intervention Trial for Prevention of Dementia (J-MINT) PRIME Tamba was a randomized controlled trial to prevent dementia. We provided a multifactorial intervention based on the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) trial methodology. The primary outcome, the cognitive composite score, improved with our intervention. Executive function/processing speed and memory improved in the intervention group. Intervention adherence was high, and no serious adverse events occurred.

Evaluating a multimodal, clinical and work-directed intervention (RTW-PIA) to support sustainable return to work among employees with mental disorders: study protocol of a multicentre, randomised controlled trial.

BACKGROUND: Mental disorders (MDs) are one of the leading causes for workforce sickness absence and disability worldwide. The burden, costs and challenges are enormous for the individuals concerned, employers and society at large. Although most MDs are characterised by a high risk of relapse after treatment or by chronic courses, interventions that link medical-psychotherapeutic approaches with work-directed components to facilitate a sustainable return to work (RTW) are rare. This protocol describes the design of a study to evaluate the (cost-)effectiveness and implementation process of a multimodal, clinical and work-directed intervention, called RTW-PIA, aimed at employees with MDs to achieve sustainable RTW in Germany. METHODS: The study consists of an effectiveness, a health-economic and a process evaluation, designed as a two-armed, multicentre, randomised controlled trial, conducted in German psychiatric outpatient clinics. Sick-listed employees with MDs will receive either the 18-month RTW-PIA treatment in conjunction with care as usual, or care as usual only. RTW-PIA consists of a face-to-face individual RTW support, RTW aftercare group meetings, and web-based aftercare. Assessments will be conducted at baseline and 6, 12, 18 and 24 months after completion of baseline survey. The primary outcome is the employees´ achievement of sustainable RTW, defined as reporting less than six weeks of working days missed out due to sickness absence within 12 months after first RTW. Secondary outcomes include health-related quality of life, mental functioning, RTW self-efficacy, overall job satisfaction, severity of mental illness and work ability. The health-economic evaluation will be conducted from a societal and public health care perspective, as well as from the employer's perspective in a cost-benefit analysis. The design will be supplemented by a qualitative effect evaluation using pre- and post-interviews, and a multimethod process evaluation examining various predefined key process indicators from different stakeholder perspectives. DISCUSSION: By applying a comprehensive, multimethodological evaluation design, this study captures various facets of RTW-PIA. In case of promising results for sustainable RTW, RTW-PIA may be integrated into standard care within German psychiatric outpatient clinics. TRIAL REGISTRATION: The study was prospectively registered with the German Clinical Trials Register ( DRKS00026232 , 1 September 2021).

Which Came First, Age-Related Hearing Loss with Tinnitus or Cognitive Impairment? What are the Potential Pathways?

Research on the causal relationship between age-related hearing loss (ARHL) and/or tinnitus and dementia is an important and fast-moving field. In this opinion paper, the up-to-date evidence and potential mechanisms for the bidirectional relationship are reviewed. We also present several critical factors that increase the challenges of understanding the causal relationship. These factors include common causes (such as aging, frailty, vascular impairment, and chronic inflammation), auditory and cognitive reserves, and the difficulty in distinguishing central auditory processing disorder (CAPD) from cognitive impairment. Finally, based on cumulative evidence, we propose an integrated mechanism in which the central auditory system might be the common target of both peripheral auditory impairment and dementia or its precursor. There is a bidirectional interaction between the peripheral and central auditory systems and between the central auditory systems and the cognitive brain. CAPD causes the depletion of auditory and cognitive reserves, and indirectly affects the peripheral auditory system via the auditory efferent system. According to the proposal, multimodal intervention might be beneficial for patients with ARHL and/or tinnitus and cognitive impairment, apart from hearing restoration by hearing aids or cochlear implants.

Predictors and sub-groups in the treatment of stress-induced exhaustion disorder.

Little is known about psychological interventions for stress-induced Exhaustion disorder (ED), and there is a need for more research to improve the outcomes obtained in treatments. The present study examines predictors of improvement, including sub-group responses, in a large sample of ED patients receiving a Multimodal intervention (MMI) based on Cognitive Behavior Therapy (N = 915). In step one, available variables were explored separately as predictors of improvement in ED symptoms. In step two, sub-groups were explored through Latent Class Analysis to reduce the heterogeneity observed in the larger group and to investigate whether combining the variables from step one predicted symptom improvement. Younger age, no previous sick leave due to ED, and scoring high on anxiety, depression, insomnia, perfectionism, and treatment credibility emerged as separate predictors of improvement. In the sub-group analyses, a sub-group including participants who were single and had a lower income showed less improvement. Overall, people with ED participating in MMI report symptom improvement regardless of characteristics before treatment. However, the present findings do have the potential to inform future treatments for ED, as they highlight perfectionism as a predictor of improvement and the importance of assessing treatment credibility during treatment.

An interdisciplinary multimodal integrative healthcare program for somatic symptom disorder, with predominant (spinal) pain.

OBJECTIVE: Although multimodal interventions are generally recommended in patients with long-term somatic symptom disorders (SSD), available evidence is limited. The current study evaluates the effectiveness of an outpatient secondary care interdisciplinary multimodal integrative healthcare program for patients with SSD and predominant (spinal) pain. METHOD: The healthcare program consisted of two active treatment phases: main 20-week program and a 12-month relapse prevention program. Participants were 4453 patients diagnosed with SSD. The primary outcome was health-related quality of life (HRQoL) assessed using the RAND-36 (i.e., mental/physical component summary) and secondary outcomes included physical and psychological symptoms assessed using the Brief Symptom Inventory (BSI) and RAND-36 subscales. Mixed linear models were used to examine the effects of the multimodal healthcare program on primary/secondary outcomes over four time points: before start 20-week program (T0), halfway 20-week program (T1), end of 20-week program (T2) and end of relapse prevention program (T3). RESULTS: Significant improvements were found from T0 to T2 for all primary variables (i.e., mental/physical component summary) and secondary variables (i.e., BSI/RAND-36 subscales), which were maintained until the end of the relapse prevention program (T3). CONCLUSION: An interdisciplinary multimodal integrative treatment for SSD is effective for improving HRQoL and reducing physical and psychological symptoms.

A Multimodal Intervention to Improve Cognition in Community-dwelling Older Adults.

OBJECTIVE: To examine the effects of a multimodal intervention composed of cognitive training, physical exercise, and group counseling on cognitive function in community-dwelling older adults. DESIGN: A four-armed, quasi-experimental intervention study. SETTING AND PARTICIPANTS: Community-dwelling adults aged 60 years and older (n = 153). INTERVENTION: Participants were allocated into multimodal intervention, cognitive training plus Taichi exercise, cognitive training, or control group. The multimodal intervention included 18 sessions of cognitive training, 18 sessions of Taichi, and 6 sessions of group reminiscence over six weeks. MEASUREMENTS: Cognitive function, depressive symptoms, and psychological well-being were assessed at the baseline, postintervention, and three-month follow-up. The primary outcome was the change in overall cognition measured by the Montreal Cognitive Assessment (MoCA) and a composite cognitive score derived from a battery of neuropsychological tests. RESULTS: For MoCA, there was no significant difference between any of the three intervention groups and controls. For composite cognition, all three intervention groups showed improvements at the three-month follow-up, with a large effect size in the cognitive training plus Taichi group (change difference 0.37, 95% CI 0.18-0.56, Hedge's g = 0.92), and medium effect sizes in the multimodal intervention group (change difference 0.23, 95% CI 0.0 -0.42, g = 0.58) and cognitive training group (change difference 0.22, 95% CI 0.03-0.42, g = 0.55). CONCLUSIONS: Multimodal intervention, cognitive training plus Taichi, and cognitive training could foster cognitive function in community-dwelling older adults. The combination of cognitive training and Taichi showed greater efficacy than the other two interventions.

Peri-treatment adverse events of primary mediastinal non-seminomatous germ cell tumors.

Primary mediastinal non-seminomatous germ cell tumors (PMNSGCT) are rare but life-threatening thoracic cancers. We report our experience from eight patients with peri-treatment adverse events. By analyzing changes in tumor extent, serum tumor markers, and pathologies between diagnosis and transfer, those events could be attributed to postbiopsy respiratory insufficiency, growing teratoma syndrome, secondary histiocytic malignancy, and PMNSGCT progression. Subjecting patients to respiratory therapy, conventional or high-dose chemotherapy, and surgery controlled the disease, with five of the eight patients surviving disease free. These outcomes indicate that integrated appropriate and timely approaches are important in tackling peri-treatment adverse events.

Multimodal intervention in 8- to 13-year-old French dyslexic readers: Study protocol for a randomized multicenter controlled crossover trial.

BACKGROUND: Developmental dyslexia, a specific and long-lasting learning disorder that prevents children from becoming efficient and fluent readers, has a severe impact on academic learning and behavior and may compromise professional and social development. Most remediation studies are based on the explicit or implicit assumption that dyslexia results from a single cause related to either impaired phonological or visual-attentional processing or impaired cross-modal integration. Yet, recent studies show that dyslexia is multifactorial and that many dyslexics have underlying deficits in several domains. The originality of the current study is to test a remediation approach that trains skills in all three domains using different training methods that are tailored to an individual's cognitive profile as part of a longitudinal intervention study. METHODS: This multicenter randomized crossover study will be conducted in three phases and will involve 120 dyslexic children between the ages of 8 and 13 years. The first phase serves as within-subject baseline period that lasts for 2 months. In this phase, all children undergo weekly speech-language therapy sessions without additional training at home (business-as-usual). During the second phase, all dyslexics receive three types of intensive interventions that last 2 month each: Phonological, visual-attentional, and cross-modal. The order of the first two interventions (phonological and visual-attentional) is swapped in two randomly assigned groups of 60 dyslexics each. This allows one to test the efficacy and additivity of each intervention (against baseline) and find out whether the order of delivery matters. During the third phase, the follow-up period, the intensive interventions are stopped, and all dyslexics will be tested after 2 months. Implementation fidelity will be assessed from the user data of the computerized intervention program and an "intention-to-treat" analysis will be performed on the children who quit the trial before the end. DISCUSSION: The main objective of this study is to assess whether the three types of intensive intervention (phase 2) improve reading skills compared to baseline (i.e., non-intensive intervention, phase 1). The secondary objectives are to evaluate the effectiveness of each intervention and to test the effects of order of delivery on reading intervention outcomes. Reading comprehension, spelling performance and reading disorder impact of dyslexic readers are assessed immediately before and after the multimodal intervention and 2 months post-intervention. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04028310. Registered on July 18, 2019.

Multimodal Chronic Pain Therapy for Adults via Smartphone: Randomized Controlled Clinical Trial.

BACKGROUND: Combination therapies delivered remotely via the internet or mobile devices are increasingly being used to improve and promote the self-management of chronic conditions. However, little is known regarding the long-term effects of these interventions. OBJECTIVE: The aim of this study is to evaluate the effectiveness of a multimodal intervention program that measures associated variables such as catastrophizing, pain acceptance, and quality of life using a mobile device in people with chronic pain in an outpatient setting. METHODS: A randomized controlled clinical trial was performed using parallel treatment groups. A total of 209 patients with chronic musculoskeletal pain were randomly assigned to one of the two study arms. The intervention group received a standard web-based psychosocial therapy-type program of activities through a smartphone for 6 weeks. The control group only had access to the Find out more section of the app, which contained audiovisual material for pain management based on a self-help approach. The primary outcome was catastrophizing measured using the Pain Catastrophizing Scale (PCS). Secondary outcomes were pain acceptance measured using the Chronic Pain Acceptance Questionnaire and health-related quality of life measured using the EuroQol Visual Analogue Scale. Assessments were conducted at baseline (T1), after treatment (T2), and at the 3-month follow-up (T3). The variations between the different phases were assessed using the percentage change rescaled with log base 2. The Cohen d was calculated based on the results of the linear mixed model. The investigators of the study who evaluated the results were not involved in patient recruitment and were blinded to the group assignment. RESULTS: Positive effects were found in the intervention group (T2-T1) in catastrophizing between the baseline and posttreatment phases (P<.001) and in helplessness (-0.72 vs 0.1; P=.002), rumination (-1.59 vs -0.53; P<.001), acceptance (0.38 vs 0.05; P=.001), and quality of life (0.43 vs -0.01; P=.002), although no significant changes were found for magnification (0.2 vs 0.77; P=.14) and satisfaction with health (0.25 vs -0.27; P=.13). Three months after treatment, significant differences were observed in the intervention group for the outcome variable of catastrophizing (PCS; -0.59 vs 0.2; P=.006) and the PCS subscales of helplessness (-0.65 vs 0.01; P=.07), rumination (1.23 vs -0.59; P=.04), and magnification (0.1 vs 0.86; P=.02). CONCLUSIONS: The results of our study suggest that app-based mobile multidimensional treatments for adults with chronic pain improve catastrophizing, quality of life, and psychological flexibility immediately after treatment and that the effects are maintained for the primary outcome of catastrophizing for at least 3 months following treatment. Moreover, they promote self-management and can be used to complement face-to-face pain treatments. TRIAL REGISTRATION: ClinicalTrials.gov NCT04509154; https://clinicaltrials.gov/ct2/show/NCT04509154.

A Malaysian Delphi consensus on managing knee osteoarthritis.

BACKGROUND: The 2013 Malaysian Clinical Practice Guidelines on the Management of Osteoarthritis (OA) recommend a linear step-up approach to manage knee OA. However, patients with knee OA often require a multimodal approach to address OA-related pain symptoms and functional limitations. This consensus aimed to provide doctors with an updated set of evidence-based, clinical experience-guided recommendations to manage knee OA. METHODS: A multi-speciality expert panel consisting of nine Malaysian physicians from different healthcare settings who manage a diverse OA patient population was convened. Using a combination of the ADAPTE process and modified Delphi method, the panel reviewed current evidence on the management of knee OA and synthesised a set of nine recommendations on the management of knee OA, supported by an algorithm that summarises the consensus' core messages. RESULTS: A multimodal intervention strategy is the mainstay of OA management and the choice of any single or multimodal intervention may vary over the course of the disease. Overall, a non-pharmacological core treatment set of patient education, weight loss and exercise is recommended for all patients. When pharmacotherapy is indicated, symptomatic slow-acting drugs for osteoarthritis are recommended at the early stage of disease, and they can be paired with physical therapy as background treatment. Concurrent advanced pharmacotherapy that includes non-steroidal anti-inflammatory drugs, intraarticular injections and short-term weak opioids can be considered if patients do not respond sufficiently to background treatment. Patients with severe symptomatic knee OA should be considered for knee replacement surgery. Management should begin with specific treatments with the least systemic exposure or toxicity, and the choice of treatment should be determined as a shared decision between patients and their team of healthcare providers. CONCLUSIONS: This consensus presents nine recommendations that advocate an algorithmic approach in the management of patients living with knee OA. They are applicable to patients receiving treatment from primary to tertiary care providers in Malaysia as well as other countries.

Standardized multimodal intervention for stress-induced exhaustion disorder: an open trial in a clinical setting.

BACKGROUND: Long-term sick-leave due to stress-related ill-health is increasing in several economically developed countries. Even though different forms of interventions are administered in regular care for stress-related disorders, such as Stress-induced Exhaustion disorder (SED), the scientific evidence for the effectiveness of such treatments is sparse. The objective of this study was to explore changes in SED-symptoms and return-to-work-rates in a large group of SED-patients participating in a standardized Multimodal intervention (MMI) in a clinical setting. METHOD: This open clinical trial tracked 390 patients who fulfilled the criteria for SED undergoing a 24-week MMI, including return-to-work-strategies. Before inclusion, all patients underwent a multi-professional assessment by a team of licensed physicians, licensed psychologists, and licensed physiotherapists. Self-rated questionnaires were administered before treatment, at treatment-start, mid-treatment, post-treatment, and at 12-month follow-up. Within-group change was evaluated over time with mixed-effects models. Beyond different symptoms, working time, sick-leave compensation, and adverse effects were also measured. RESULTS: There were significant improvements in symptoms of SED, burnout, anxiety, depression, and insomnia, with large within-group effect sizes (d = 0.91-1.76), improvements that were maintained at 12-month follow-up. Furthermore, there was a significant increase in quality of life and large improvements in average working time and sick-leave compensation. Some adverse effects were reported, mainly concerning an increase in stress, anxiety, and worry. CONCLUSION: SED-patients participating in this standardized MMI reported large symptom alleviation, increased working time and reduced sick-leave compensation, indicating a beneficial treatment. There were some adverse effects, but no more so than other psychological treatments. This study confirms previous findings that high levels of depression and anxiety decrease to sub-clinical levels during treatment, while symptoms of SED also decline, yet still persists above sub-clinical levels at 12-month follow-up. On the whole, this open clinical trial suggests that a standardized MMI, administered in a clinical setting, improves symptoms and return-to-work rates in a clinically representative SED-population. TRIAL REGISTRATION: This study was registered on Clinicaltrials.gov 2017.12.02 (Identifier: NCT03360136 ).

Multimodal Intervention Approach Reduces Catheter-associated Urinary Tract Infections in a Rural Tertiary Care Center.

OBJECTIVE: To compare the catheter-associated urinary tract infections (CAUTI) standardized infection rate (SIR) before and after implementation of a multimodal intervention approach in a rural tertiary hospital. DESIGN: Before-after analysis of a multimodal intervention to evaluate primary outcomes of the incidence of inpatient CAUTI, the SIR for CAUTI, and number of urinary catheter days. SETTING: All inpatient departments of a rural 504-bed tertiary care facility in the Midwest. PARTICIPANTS: Patients admitted for in-patient care. INTERVENTIONS: A multimodal intervention composed of: (a) physician and nurse education, (b) modification of progress note templates and daily provider reminders for the clinical necessity of catheters, (c) implementing established best practices for eliminating CAUTIs, (d) advocating for alternative toileting options, and (e) promoting aseptic techniques for insertion and removal of catheters. SIR, CAUTI, and the number of urinary catheter days were obtained before and after implementation of the multimodal intervention in 2015 and 2017, respectively. RESULTS: After a one-year timeframe of intervention, CAUTI event rates decreased, and SIR for CAUTI was reduced by 60.2% (from 1.524 to 0.607) with P value<0.05. Urinary catheter days were also reduced from 16,195 in 2015 to 13,348 in 2017 (17.6% reduction) with P value <0.05. CONCLUSIONS: Incidence of CAUTIs were significantly reduced with a team effort involving infection control, physician and nursing education, modification of progress note and templates and daily provider reminders for the clinical necessity of catheters and appropriate usage of urinary catheter with corresponding reduction in urinary catheter days.