Neuromuscular electrical stimulation to combat cognitive aging in people with spinal cord injury: protocol for a single case experimental design study.

INTRODUCTION: Individuals with spinal cord injury (SCI) can experience accelerated cognitive aging. Myokines (factors released from muscle cells during contractions), such as brain-derived neurotrophic factor (BDNF), are thought to have beneficial effects on cognition. Neuromuscular electrical stimulation (NMES) was shown to elicit a large release of myokines. However, the effects of NMES on cognitive function have not been studied. OBJECTIVE: To present the study protocol for a clinical trial evaluating the effects of NMES aimed at improving cognition and BDNF. METHODS: A replicated randomized three-phases single-case experimental design (SCED) with sequential multiple baseline time series and a single-armed prospective trial will be conducted with 15 adults with chronic SCI (> 12 months after injury) above L1 neurological level undergoing 30-min quadriceps NMES, 3 days per week for 12 weeks. MAIN STUDY ENDPOINTS: Primary endpoint is cognitive performance (assessed by a smartphone test) conducted three times per week during the baseline phase with random duration of 3 to 8 weeks, the intervention phase of 12 weeks, and the follow-up phase of 3 weeks after a no measurement rest period of 12 weeks. Secondary endpoints are changes in BDNF levels and cognitive performance measured before the baseline period, before and after intervention and after a 12 weeks follow-up. CONCLUSION: This will be the first study investigating the effects of 12 weeks NMES on both cognition and BDNF levels in individuals with SCI. The SCED results provide information on individual treatment effect courses which may direct future research. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05822297, 12/01/2023).

Benefits of a targeted rehabilitation of number transcoding in secondary acalculia: A single-case experimental design.

BACKGROUND: Despite its potentially significant functional and emotional impact, acalculia is still too rarely assessed and managed by speech and language therapists. Research on the rehabilitation of numerical transcoding remains scarce in the literature and, despite positive results, presents a low level of evidence. AIMS: The present study aims to evaluate the effectiveness of a targeted rehabilitation of numerical transcoding in two patients suffering from a chronic secondary acalculia. METHODS & PROCEDURES: Two post-brain injury females with secondary acalculia took part in a single-case experimental design with multiple baseline across subjects according to a three-phase experimental protocol: baseline involving global cognitive rehabilitation (5-7 measurements with randomized sequential introduction); targeted intervention (10 measurements); follow-up (2 immediate measurements and 1 month after the end of the intervention). Repeated outcome measures consisted of six lists composed of numbers of equivalent difficulty that were used alternately to assess numerical transcoding. We used a reverse digit span as a control measure to assess the specificity of the intervention. Rehabilitation lasted 5 weeks and consisted of errorless learning with colour cues, tables and number-words cards. OUTCOMES & RESULTS: During baseline period involving global cognitive rehabilitation, transcoding scores remained unchanged. In contrast, there was a significant improvement in scores for both patients during the intervention phase targeting transcoding and maintenance of benefits 1-month post-intervention. CONCLUSIONS & IMPLICATIONS: This study demonstrates that a specific rehabilitation targeting numerical transcoding following chronic secondary acalculia can be effective in improving transcoding skills. WHAT THIS PAPER ADDS: What is already known on the subject Transcoding difficulties in patients with acalculia can cause a significant disability in everyday life activities. In secondary acalculia, rehabilitation of cognitive functions associated with number processing (attention, working memory, language) is not sufficient for improvement of transcoding. What this paper adds to existing knowledge An intervention specifically targeting numerical transcoding significantly and durably improves the skills of patients with chronic secondary acalculia. What are the potential or actual clinical implications of this work? Procedural error-free intervention using colour cueing, tables, cards with number-words, copy and repetition seems effective to improve transcoding skills in chronic acalculia.

How to assess and take into account trend in single-case experimental design data.

One of the data features that are expected to be assessed when analyzing single-case experimental designs (SCED) data is trend. The current text deals with four different questions that applied researchers can ask themselves when assessing trend and especially when dealing with improving baseline trend: (a) What options exist for assessing the presence of trend?; (b) Once assessed, what criterion can be followed for deciding whether it is necessary to control for baseline trend?; (c) What strategy can be followed for controlling for baseline trend?; and (d) How to proceed in case there is baseline trend only in some A-B comparisons? Several options are reviewed for each of these questions in the context of real data, and tentative recommendations are provided. A new user-friendly website is developed to implement the options for fitting a trend line and a criterion for selecting a specific technique for that purpose. Trend-related and more general data analytical recommendations are provided for applied researchers.Trial registration: ClinicalTrials.gov identifier: NCT04560777.

Assessment of executive function impairments in adults with acquired brain injury across single-case experimental design: A scoping review of primary outcomes.

The use of single-case experimental design (SCED) to evaluate cognitive remediation is growing. SCEDs require rigorous methodology and appropriate choice of primary outcomes. To review primary outcomes that assess executive function impairments in patients with acquired brain injury (ABI). A scoping review was conducted using the Arksey and O'Malley framework and the PRISMA extension for scoping review (PRISMA-ScR). Five databases were searched resulting in the inclusion of twenty-one studies. Primary outcomes were extracted and classified according to the type of measure, ecological setting and sources of possible bias. A wide variety of primary outcomes were identified; the majority of which evaluated behavioural performance during a real-life activity or in a real-life simulated setting. The most frequent bias observed across outcomes was the coaching effect. The findings of this scoping review highlight the importance of selecting appropriate outcomes for repeated measures in SCED studies. Direct observation of the target behaviour is a potential gold standard for assessing the effectiveness of a cognitive intervention.

The effect of eye movement desensitization and reprocessing on fibromyalgia: A multiple-baseline experimental case study across ten participants.

Fibromyalgia (FM) is a chronic pain disorder characterized by widespread musculoskeletal pain, fatigue, and stiffness in muscles and joints. Traumatic life experiences and post-traumatic stress symptoms play a role in its development and persistence. Although previous research suggests that pain and FM symptoms decrease after eye movement desensitization and reprocessing (EMDR) therapy, its effectiveness has not been investigated in a controlled manner. The present study investigated the effectiveness of a six-session, 90-minute EMDR therapy using a multiple baseline single-case experimental design (SCED) across ten adult females with FM. The SCED involved a baseline, intervention, one- and three-month follow-up phase. The primary outcome was pain. Secondary outcomes included post-traumatic stress symptoms, other FM symptoms (fatigue, stiffness in muscles and joints), and the impact of FM on daily activities and sleep. Data were statistically analyzed by primarily testing means across phases on an individual and group level. Post-traumatic stress symptoms improved significantly in seven participants. Pain severity decreased significantly in six participants, with three of them maintaining significant improvement three months later. One participant showed clinically relevant change one month later. Furthermore, improvements were observed in secondary outcome measures. The findings support the efficacy of EMDR in reducing FM symptoms.

Aphasia, depression, and psychological therapy (ADaPT): A single case design evaluation of a modified cognitive behavioural therapy to treat depressive symptoms in stroke survivors with aphasia.

Cognitive behavioural therapy (CBT) can effectively treat depression in the general population, but there is a lack of studies evaluating CBT tailored to specific cognitive and communication needs of individuals with post-stroke aphasia. We aimed to evaluate the feasibility and preliminary efficacy of a modified CBT intervention to ameliorate depressive symptoms. An ABA withdrawal/reversal single case design with concurrent multiple baselines (2.5, 4.5, or 6.5 weeks) was repeated across 10 participants (six male, four female) with post-stroke aphasia and self-reported depression. Participants completed 10 individual intervention sessions with a clinical neuropsychologist and a 4-week follow-up. The primary outcome was self-rated depression, and secondary outcomes included observer-rated symptoms of depression and anxiety. Data were analysed visually and statistically controlling for baseline trend. Feasibility was addressed by analysing recruitment and retention rates, treatment adaptations, and fidelity ratings. Three participants self-reported decreased depression levels during the intervention phase, which was sustained for two participants. Four additional participants improved during the follow-up phase. Close others reported sustained improvements in depressive symptoms (six participants) and anxiety symptoms (seven participants). Modified CBT appears feasible and potentially efficacious in reducing depressive symptoms in post-stroke aphasia. A randomized controlled trial is warranted, and should consider additional treatment sessions.

Ultra-brief acceptance & commitment therapy for inpatients with psychosis - a single-case experimental design investigating processes of change.

People with primary psychosis are among the most seen in inpatient psychiatry. Treatment guidelines recommend both pharmacological and psychological treatments. However, psychological treatments are not routinely offered in many settings. There is also a lack of research on psychological treatments for this vulnerable population in the inpatient setting. The first aim of the current study was to examine treatment effects of a brief form of Acceptance and Commitment Therapy on outcomes valued by the treatment recipients. The second aim was to explore hypothetical processes of change in relation to outcomes over time. Three people with primary psychosis were treated for two to four sessions. A replicated single-case experimental design with multiple baselines across subjects (Clinical Trials registration number ID NCT04704973) was employed to examine treatment effects. The Personal Questionnaire (PQ) was used as primary outcome, symptom believability and preoccupation as proposed processes of change. Data were analyzed using visual inspection, calculation of Tau-U values, and cross-lagged correlation. All participants improved significantly on PQ and the symptom preoccupation measure. Two improved significantly on the symptom believability measure. Cross-lagged correlation analyses showed no clear mediation. Change in proposed processes of change and primary outcome predominantly happened concomitantly, although patterns of results reflected individual differences.

'Living in the Present' mindfulness for parents of children with skin conditions: a single group case series.

BACKGROUND: Parents of children with skin conditions can experience stress from the additional responsibilities of care. However, there is a lack of psychological interventions for families affected by a dermatological diagnosis. AIMS: To investigate (1) whether delivering the 'Living in the Present' mindfulness curriculum to parents of children with skin conditions reduced stress and increased both parental/child quality of life (QoL), and (2) determine intervention acceptability. METHOD: Ten parents of children with eczema, ectodermal dysplasia, ichthyosis, and alopecia took part in a mindfulness-based intervention. Using mixed methods, a single-group experimental case design (SCED) was conducted and supplemented by thematic analysis of exit interviews. Parents completed idiographic measures of parenting stress, standardised measures of QoL, stress, mindfulness, and took part in exit interviews. Children also completed QoL measures. RESULTS: Tau-U analysis of idiographic measures revealed three parents showed some significant improvements in positive targets, and five parents showed some significant improvements in negative targets. Assessment of reliable change demonstrated that: one parent showed improvement in mindful parenting, three parents showed improvement in parenting stress, seven parents showed improvement in anxiety, three parents showed improvements in depression, six parents showed improvement in QoL, and four children showed improvement in QoL. However, two parents showed increased anxiety. Thematic analysis revealed positive changes to mood following mindfulness, although challenges were highlighted, including sustaining home practice. CONCLUSION: Findings suggest this specific form of mindfulness intervention could be effective for parents of children with skin conditions; however, further robust studies are needed.

Multilevel modeling in single-case studies with zero-inflated and overdispersed count data.

Count outcomes are frequently encountered in single-case experimental designs (SCEDs). Generalized linear mixed models (GLMMs) have shown promise in handling overdispersed count data. However, the presence of excessive zeros in the baseline phase of SCEDs introduces a more complex issue known as zero-inflation, often overlooked by researchers. This study aimed to deal with zero-inflated and overdispersed count data within a multiple-baseline design (MBD) in single-case studies. It examined the performance of various GLMMs (Poisson, negative binomial [NB], zero-inflated Poisson [ZIP], and zero-inflated negative binomial [ZINB] models) in estimating treatment effects and generating inferential statistics. Additionally, a real example was used to demonstrate the analysis of zero-inflated and overdispersed count data. The simulation results indicated that the ZINB model provided accurate estimates for treatment effects, while the other three models yielded biased estimates. The inferential statistics obtained from the ZINB model were reliable when the baseline rate was low. However, when the data were overdispersed but not zero-inflated, both the ZINB and ZIP models exhibited poor performance in accurately estimating treatment effects. These findings contribute to our understanding of using GLMMs to handle zero-inflated and overdispersed count data in SCEDs. The implications, limitations, and future research directions are also discussed.

Model selection of GLMMs in the analysis of count data in single-case studies: A Monte Carlo simulation.

Generalized linear mixed models (GLMMs) have great potential to deal with count data in single-case experimental designs (SCEDs). However, applied researchers have faced challenges in making various statistical decisions when using such advanced statistical techniques in their own research. This study focused on a critical issue by investigating the selection of an appropriate distribution to handle different types of count data in SCEDs due to overdispersion and/or zero-inflation. To achieve this, I proposed two model selection frameworks, one based on calculating information criteria (AIC and BIC) and another based on utilizing a multistage-model selection procedure. Four data scenarios were simulated including Poisson, negative binominal (NB), zero-inflated Poisson (ZIP), and zero-inflated negative binomial (ZINB). The same set of models (i.e., Poisson, NB, ZIP, and ZINB) were fitted for each scenario. In the simulation, I evaluated 10 model selection strategies within the two frameworks by assessing the model selection bias and its consequences on the accuracy of the treatment effect estimates and inferential statistics. Based on the simulation results and previous work, I provide recommendations regarding which model selection methods should be adopted in different scenarios. The implications, limitations, and future research directions are also discussed.

Leveraging Single-Case Experimental Designs to Promote Personalized Psychological Treatment: Step-by-Step Implementation Protocol with Stakeholder Involvement of an Outpatient Clinic for Personalized Psychotherapy.

Our objective is to implement a single-case experimental design (SCED) infrastructure in combination with experience-sampling methods (ESM) into the standard diagnostic procedure of a German outpatient research and training clinic. Building on the idea of routine outcome monitoring, the SCED infrastructure introduces intensive longitudinal data collection, individual effectiveness measures, and the opportunity for systematic manipulation to push personalization efforts further. It aims to empower psychotherapists and patients to evaluate their own treatment (idiographic perspective) and to enable researchers to analyze open questions of personalized psychotherapy (nomothetic perspective). Organized around the principles of agile research, we plan to develop, implement, and evaluate the SCED infrastructure in six successive studies with continuous stakeholder involvement: In the project development phase, the business model for the SCED infrastructure is developed that describes its vision in consideration of the context (Study 1). Also, the infrastructure's prototype is specified, encompassing the SCED procedure, ESM protocol, and ESM survey (Study 2 and 3). During the optimization phase, feasibility and acceptability are tested and the infrastructure is adapted accordingly (Study 4). The evaluation phase includes a pilot implementation study to assess implementation outcomes (Study 5), followed by actual implementation using a within-institution A-B design (Study 6). The sustainability phase involves continuous monitoring and improvement. We discuss to what extent the generated data could be used to address current questions of personalized psychotherapy research. Anticipated barriers and limitations during the implementation processes are outlined.

A pilot multiple-baseline study of a mobile cognitive behavioral therapy for the treatment of eating disorders in university students.

OBJECTIVE: Eating disorders (EDs) are serious psychiatric disorders associated with substantial morbidity and mortality that are prevalent among university students. Because many students do not receive treatment due to lack of access on university campuses, mobile-health (mHealth) adaptations of evidence-based treatments represent an opportunity to increase treatment accessibility and engagement. The purpose of this study was to test the initial efficacy of Building Healthy Eating and Self-Esteem Together for University Students (BEST-U), which is a 10-week mHealth self-guided cognitive-behavioral therapy (CBT-gsh) app that is paired with a brief 25-30-min weekly telehealth coaching, for reducing ED psychopathology in university students. METHOD: A non-concurrent multiple-baseline design (N = 8) was used to test the efficacy of BEST-U for reducing total ED psychopathology (primary outcome), ED-related behaviors and cognitions (secondary outcomes), and ED-related clinical impairment (secondary outcome). Data were examined using visual analysis and Tau-BC effect-size calculations. RESULTS: BEST-U significantly reduced total ED psychopathology and binge eating, excessive exercise, and restriction (effect sizes ranged from -0.39 to -0.92). Although body dissatisfaction decreased, it was not significant. There were insufficient numbers of participants engaging in purging to evaluate purging outcomes. Clinical impairment significantly reduced from pre-to-post-treatment. DISCUSSION: The current study provided initial evidence that BEST-U is a potentially efficacious treatment for reducing ED symptoms and ED-related clinical impairment. Although larger-scale randomized controlled trials are needed, BEST-U may represent an innovative, scalable tool that could reach greater numbers of underserved university students than traditional intervention-delivery models. PUBLIC SIGNIFICANCE: Using a single-case experimental design, we found evidence for the initial efficacy of a mobile guided-self-help cognitive-behavioral therapy program for university students with non-low weight binge-spectrum eating disorders. Participants reported significant reductions in ED symptoms and impairment after completion of the 10-week program. Guided self-help programs show promise for filling an important need for treatment among university students with an ED.

Simultaneous assessment and training of an upper-limb amputee using incremental machine-learning-based myocontrol: a single-case experimental design.

BACKGROUND: Machine-learning-based myocontrol of prosthetic devices suffers from a high rate of abandonment due to dissatisfaction with the training procedure and with the reliability of day-to-day control. Incremental myocontrol is a promising approach as it allows on-demand updating of the system, thus enforcing continuous interaction with the user. Nevertheless, a long-term study assessing the efficacy of incremental myocontrol is still missing, partially due to the lack of an adequate tool to do so. In this work we close this gap and report about a person with upper-limb absence who learned to control a dexterous hand prosthesis using incremental myocontrol through a novel functional assessment protocol called SATMC (Simultaneous Assessment and Training of Myoelectric Control). METHODS: The participant was fitted with a custom-made prosthetic setup with a controller based on Ridge Regression with Random Fourier Features (RR-RFF), a non-linear, incremental machine learning method, used to build and progressively update the myocontrol system. During a 13-month user study, the participant performed increasingly complex daily-living tasks, requiring fine bimanual coordination and manipulation with a multi-fingered hand prosthesis, in a realistic laboratory setup. The SATMC was used both to compose the tasks and continually assess the participant's progress. Patient satisfaction was measured using Visual Analog Scales. RESULTS: Over the course of the study, the participant progressively improved his performance both objectively, e.g., the time required to complete each task became shorter, and subjectively, meaning that his satisfaction improved. The SATMC actively supported the improvement of the participant by progressively increasing the difficulty of the tasks in a structured way. In combination with the incremental RR-RFF allowing for small adjustments when required, the participant was capable of reliably using four actions of the prosthetic hand to perform all required tasks at the end of the study. CONCLUSIONS: Incremental myocontrol enabled an upper-limb amputee to reliably control a dexterous hand prosthesis while providing a subjectively satisfactory experience. The SATMC can be an effective tool to this aim.

Acceptance and commitment therapy for individuals with depressive and anxiety symptoms following acquired brain injury: A non-concurrent multiple baseline design across four cases.

Patients with acquired brain injury (ABI) often experience symptoms of anxiety and depression. Until now, evidence-based treatment is scarce. This study aimed to investigate the effectiveness of Acceptance and Commitment Therapy (ACT) for patients with ABI. To evaluate the effect of ACT for people with ABI, a non-concurrent multiple baseline design across four cases was used. Participants were randomly assigned to a baseline period, followed by treatment and then follow-up phases. Anxiety and depressive symptoms were repeatedly measured. During six measurement moments over a year, participants filled in questionnaires measuring anxiety, depression, stress, participation, quality of life, and ACT-related processes. Randomization tests and NAP scores were used to calculate the level of change across phases. Clinically significant change was defined with the Reliable Change Index. Three out of four participants showed medium to large decreases in anxiety and depressive symptoms (NAP = 0.85 till 0.99). Furthermore, participants showed improvements regarding stress, cognitive fusion, and quality of life. There were no improvements regarding psychological flexibility, value-driven behaviour, or social participation. This study shows that ACT is possibly an effective treatment option for people experiencing ABI-related anxiety and depression symptoms. Replication with single case or large scale group studies is needed to confirm these findings.

Computerized working memory training in males with Duchenne muscular dystrophy: A single case experimental design study.

Learning disabilities (LDs) and working memory problems (WM) are common brain-related comorbidities in Duchenne muscular dystrophy (DMD). Despite growing evidence on the efficacy of computerized WM training in children with LDs, research in DMD is lacking. This exploratory study assessed whether training (1) improves dystrophin-associated WM problems in DMD, (2) effects are present at post-intervention, 3 and 8 months follow-up, and (3) improves problems that arise from their LDs. A single case non-concurrent multiple baseline across patients design evaluated the target behaviour i.e. parental reports of WM problems of four DMD participants with LDs. Additionally, participants completed cognitive tests of verbal and visual WM, academics, attention, processing speed and fluid reasoning. Parents and teachers completed behavioural questionnaires. Testing and questionnaires were administered at baseline, post-intervention (T2), 3 (T3) and 8 (T4) months follow-up. Positive effects on target behaviour were found for three of four participants, but parental bias cannot be ruled out. Short and long-term, near-and far transfer effects were found for verbal and visual WM (T2:n = 2, T3&T4:n = 1), reading (T2:n = 4,T3:n = 3,T4:n = 2), arithmetic (all T:n = 1), processing speed (all T:n = 4) and fluid reasoning (T2:n = 1,T3&T4:n = 2). Behavioural questionnaires displayed minimal changes (T2:n = 1,T3&T4:n = 2). Promising WM training results are shown in DMD that merit further research.

What is the effect of personalized cognitive strategy instruction on facilitating return-to-learn for individuals experiencing prolonged concussion symptoms?

The purpose of this study was to evaluate the degree to which personalized cognitive strategy instruction (PCSI) assisted students with prolonged concussion symptoms (PCS) to achieve functional and academic-related goals. It was hypothesized that goal attainment on collaboratively developed functional goals and selected scores on the pre/post outcome measurements would improve following the delivery of PCSI. A non-concurrent multiple baseline design was utilized across three female participants ages 13-16. The weekly status tracking measurement of participant performance served as the primary measurement analysed to determine the existence of a functional relation between the addition of PCSI to psychoeducation and the achievement of participant outcome. Although visual analysis of the plotted status tracking data did not support the existence of a functional relation, all three participants met or exceeded functional goals on their goal attainment scales. A Tau-U analysis supported a small treatment effect. The positive response to the intervention from two of the three participants in addition to goal attainment for all three participants suggests PCSI has potential to mitigate cognitive challenges in adolescents with PCS. Implications for future research and methods to promote ecological measurement of intervention effects are discussed.

The effectiveness of mindfulness-based cognitive therapy for social anxiety symptoms in people living with alopecia areata: a single-group case-series design.

BACKGROUND: Alopecia areata (AA) is an immunological disorder characterised by hair loss. Individuals with AA report high levels of social anxiety. One intervention that holds potential for reducing social anxiety in individuals with AA is mindfulness-based cognitive therapy (MBCT). AIMS: Our key aim was to investigate whether MBCT reduces social anxiety in individuals with AA. The study also investigated whether MBCT reduces depression, general anxiety, and increases quality of life and increases trait mindfulness in individuals with AA. METHOD: Five participants with AA took part in an 8-session in-person MBCT intervention. A multiple-baseline single-group case series design was adopted. Idiographic measures of social anxiety were measured each day from baseline, through intervention, to follow-up. Standardised questionnaires of trait mindfulness, social anxiety, depression, anxiety, and quality of life were completed at baseline, post-intervention, and at 4-week follow-up. RESULTS: All participants completed the MBCT course, but one participant was excluded from the idiographic analysis due to a high amount of missing data. The remaining four participants demonstrated reductions in idiographic measures of social anxiety from baseline to follow-up. These effects were larger between baseline and follow-up, than between baseline and post-intervention. Two participants demonstrated significant improvement in standardised measures of wellbeing from baseline to follow-up - they also practised mindfulness most regularly at home between sessions. CONCLUSION: MBCT may be effective in reducing social anxiety and improving wellbeing in individuals with AA, although this might be dependent on the extent to which participants regularly practise mindfulness exercises.

Modeling multiple dependent variables in meta-analysis of single-case experimental design using multilevel modeling.

Although meta-analyses of single-case experimental design (SCED) often include multiple types of dependent variables (DVs), multiple DVs are rarely considered within models in the analysis. Baek et al. (Journal of Experimental Education, 90(4), 934-961, 2022) identified several statistical issues that arise when researchers fail to model multiple DVs in meta-analyses of SCED data. However, the degree to which non-modeling of multiple DVs impacts the results of the meta-analysis of SCED has not been fully examined. In this simulation study, we have systematically investigated the impact of non-modeling of multiple DVs when analyzing meta SCED data using multilevel modeling. The result demonstrates that modeling multiple DVs has advantages over the non-modeling option for meta-analysis of SCED. Modeling multiple DVs enables the determination of precise effects from different DVs in addition to the unbiased and accurate average effect and accurate estimates and inferences for the error variances at the study level as well as the observation level. The current study also reveals potential factors (i.e., the number of DVs, degree of heterogeneity in the level-1 error variances and autocorrelation, and presence of the moderator effect) that impact the precision and accuracy of the variance parameters.

Community-based practical behavioral intervention in public transportation for people with acquired brain injury: study of two cases using a single-case experimental design study.

The purpose of this paper was to report on the progress of a behavioral approach to enable patients with acquired brain injury (age 57, male, stroke and age 36, old, female, TBI) using a community activity support center to commute alone using public transportation. In this study, two ABI patients were intervened to enable them to use public transportation. The frequency of intervention was once a month or once a week. The two community-dwelling adults each had post-ABI attention and memory deficits and anxiety. A-B-A single-case experimental design was employed for this study. The transportation route was stepped into multiple steps. Each step was scored in a unique way to determine the degree of assistance the participant received from others. This score was considered the main outcome. Tau-U analysis was used for statistical analysis. Statistically significant improvements in public transportation use were shown between baseline and intervention. There were no significant differences between the intervention and follow-up periods. The results suggest that behavioral interventions are beneficial in reacquiring the ability to use public transportation and that the intervention effects are sustained.

StudyU: A Platform for Designing and Conducting Innovative Digital N-of-1 Trials.

N-of-1 trials are the gold standard study design to evaluate individual treatment effects and derive personalized treatment strategies. Digital tools have the potential to initiate a new era of N-of-1 trials in terms of scale and scope, but fully functional platforms are not yet available. Here, we present the open source StudyU platform, which includes the StudyU Designer and StudyU app. With the StudyU Designer, scientists are given a collaborative web application to digitally specify, publish, and conduct N-of-1 trials. The StudyU app is a smartphone app with innovative user-centric elements for participants to partake in trials published through the StudyU Designer to assess the effects of different interventions on their health. Thereby, the StudyU platform allows clinicians and researchers worldwide to easily design and conduct digital N-of-1 trials in a safe manner. We envision that StudyU can change the landscape of personalized treatments both for patients and healthy individuals, democratize and personalize evidence generation for self-optimization and medicine, and can be integrated in clinical practice.