Psychological Therapy for Functional Neurological Disorder: Examining Impact on Dissociation, Psychological Distress and General Functioning.

Functional neurological disorder (FND) represents a broad group of motor and sensory clinical symptoms which cannot be explained by other neurological diagnoses. Dissociation is considered a key mechanism in their development and maintenance. Despite psychological therapy being the recommended choice of treatment for FND, evidence for its effectiveness is in its infancy. This study explored the dissociative profile of forty-seven patients with FND and evaluated whether individual psychological therapy improved dissociative symptoms, psychological distress and general functioning among twenty-five adults with FND. Patients completed the Multiscale Dissociation Inventory, the EuroQol five-dimensional descriptive system, the General Anxiety Disorder-7 scale and the Patient Health Questionnaire-9. Our sample showed high levels of disengagement, depersonalization and memory disturbance at baseline. Treatment was associated with significant improvements in general functioning, and symptoms of dissociation and anxiety. Improvements in dissociative experiences were found to be possibly due to reduction in anxiety. Improvements in depression were the strongest predictor of improvements in general functioning. Limitations and areas for further research are discussed.

Empowering personalized medicine: unleashing the potential of patient-derived explants in clinical practice.

In recent decades, significant progress has been made in understanding the molecular characteristics of cancer and its microenvironment, leading to the development of life-saving treatments. However, patients often experience side effects from standard therapies, highlighting the need for personalized medicine. Personalized medicine aims to customize drug therapy and preventive care based on individual patients' specific requirements. The heterogeneity within tumors and among patients necessitates personalized medicine approaches. Patient-derived organoids (PDOs), xenografts (PDXs), and explants (PDEs) have emerged as valuable models for studying tumor behaviour and drug response. This paper aims to summarize the latest advancements in patient-derived explants, focusing on their potential utility in the clinic. Different methods for culturing PDEs, including the free-floating approach, the grid method, and sponge scaffolds, are discussed. These approaches provide opportunities for long-term viability, oxygen and nutrient supply, and maintenance of tissue integrity. Additionally, various solid tumor models using PDEs are highlighted, together with assays to study PDE viability, characteristics, and response to drug treatment.

Effects of a highly intensive balance therapy camp in children with developmental coordination disorder - An intervention protocol.

BACKGROUND: Children with Developmental Coordination Disorder (DCD) often (<87 %) experience postural control problems, impacting all levels of the International Classification of Functioning, Disability and Health (ICF) including their daily participation, self-esteem and mental health. Due to the multisystemic nature of postural control, comprehensive therapy should target all systems which is currently not the case. Highly intensive therapy is effective and commonly used in pediatric populations, but has not been explored yet to train postural control in children with DCD. AIMS: To investigate the effects of a highly intensive functional balance therapy camp at all ICF levels in children with DCD. METHODS AND PROCEDURES: The effects on postural control, muscle activity, brain alterations, self-perceived competence, self-identified goals, gross motor activities and participation are evaluated. Participants are assessed pre- and post-intervention, including a 3 months follow-up. Forty-eight children with DCD, aged 6-12 years old, receive 40 h of comprehensive balance training. This intervention is fun, individually tailored, targets all postural control systems, implements different motor learning strategies and includes both individual and group activities. CONCLUSION: Novel insights into the effects of a highly intensive comprehensive balance therapy camp designed for children with DCD will be gained at all levels of the ICF.

Comparisons between group- and individual-based interventions to support recovery from stroke and ischaemic heart disease in the community: a scoping review.

PURPOSE: To map and summarise available literature on the effectiveness or other benefits of group- and individual-based interventions provided for adults living with stroke or ischaemic heart disease (IHD) in the community. MATERIAL AND METHODS: The review was conducted based on JBI methodology and reported using Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. Articles were retrieved from: Medline, PsychInfo, Embase, Scopus, and CINAHL from 2002-2022. Extracted data from eligible studies included type of health outcomes (e.g., impairments), retention and adherence, social connectedness, and the costs associated with group- and individual-based interventions. RESULTS: After screening, five articles (representing 4 unique studies) comparing a group- and individual-based intervention were included (total sample size n = 87). Three types of interventions were assessed: exercise (3/5), communication (1/5), and occupational therapy (1/5). Effectiveness of group- and individual-based interventions at improving health outcomes (i.e. physical ability, communication, motivation, and quality of life) is unclear. Currently there is insufficient evidence to guide clinical practice. CONCLUSIONS: There is limited evidence comparing interventions delivered in a group and individual modality for adults living with stroke or IHD. Adequately powered studies are needed to determine if mode of delivery is equivalent or more cost effective.

Rehabilitation interventions can be offered individually or in group settings with clinicians choosing the most appropriate modality.Both group- and individual-based interventions have advantages and disadvantages, with clinical, practical, and economic factors as important considerations when deciding between the two modalities.Based on this scoping review, the authors conclude that there is currently insufficient evidence to guide clinical practice in deciding which mode of delivery (group or individual) is optimal.There is insufficient research evidence to guide clinicians in their choice between offering rehabilitation interventions for stroke or IHD in groups or individually.

Individual Affirming Care: Psychological and Social Approaches to Trans and Gender-Diverse Youth.

Clinicians working with youth encounter transgender and gender-diverse youth and play a role in supporting the psychological and social well-being of youth and their families. Mental health clinicians start with a thorough assessment, development of a biopsychosocial formulation of the youth, and a collaborative treatment plan. Determining if the youth meets diagnostic criteria for Gender Dysphoria and identifying comorbid mental health diagnoses inform recommendations for psychiatric medication management, individual and/or family therapy interventions, and/or referrals to medical or surgical colleagues. Supporting development of a coherent identity narrative and healthy interpersonal attachments with others is an important goal of treatment interventions.

Organoid models derived from patients with malignant phyllodes tumor of the breast.

PURPOSE: Phyllodes tumor of the breast is a kind of rare neoplasm, which accounts for less than 1% of all breast tumors. Malignant phyllodes tumor (MPT) is the highest risk subtype of phyllodes tumor, and is characterized by the tendency of local recurrence and distant metastasis. The prediction of prognosis and the individual therapy for MPT is still challenging. It's urgent to develop a new reliable in vitro preclinical model in order to understand this disease better and to explore appropriate anticancer drugs for individual patients. METHODS: Two surgically resected MPT specimens were processed for organoid establishment. MPT organoids were subsequently subjected to H&E staining, immunohistochemical analysis and drug screening, respectively. RESULTS: We successfully established two organoid lines from different patients with MPT. The MPT organoids can well retain the histological features and capture the marker expression in original tumor tissues, including p63, vimentin, Bcl-2, CD34, c-Kit, and Ki-67, even after a long-term culture. The dose titration tests of eight typical chemotherapeutic drugs (paclitaxel, docetaxel, vincristine, doxorubicin, cisplatin, gemcitabine, cyclophosphamide, ifosfamide) on the two MPT organoid lines showed patient-specific drug responses and varying IC50 values. Of all the drugs, doxorubicin and gemcitabine showed the best anti-tumor effect on the two organoid lines. CONCLUSION: Organoids derived from MPT may be a novel preclinical model for testing personalized therapies for patients with MPT.

Effects of UGT1A, CYP2C9/19 and ABAT polymorphisms on plasma concentration of valproic acid in Chinese epilepsy patients.

Aim: To evaluate the association between genetic polymorphisms and plasma concentration-to-dose ratio of valproic acid (CDRV) in Chinese epileptic patients. Methods: A total of 46 epileptic patients treated with valproic acid therapy were enrolled. 18 SNPs in nine genes related to valproic acid were directly sequenced with Sanger methods. Results: Patients carrying UGT1A6 heterozygous genotypes had significantly lower CDRV than those carrying the wild-type genotypes. In contrast, patients with the homozygote genotypes of CYP2C9 and ABAT had higher CDRV than those with the wild-type genotypes and patients with the heterozygous genotypes of CYP2C19 had higher CDRV. Conclusion: Detection of genetic polymorphism in these genes might facilitate an appropriate dose of valproic acid for epileptic patients. Further studies with larger cohorts are necessary to underpin these observations.

A Group Therapy Program for Parentally Bereaved Young Adults With Grief Complications: Rationale, Method and Case Examples.

Considerable effort has gone into studying bereavement in children, adults and the elderly, but few studies have investigated the effects of bereavement or grief interventions in young adults. Even fewer studies have reported on the effect of interventions for young adults with grief complications. The present study seeks to help fill this gap by describing a Danish treatment program specially developed for young adults with complicated grief reactions. The dual process model of coping with bereavement, psychodynamic theory, and a narrative approach provide the foundation for the treatment. In addition, it utilizes an eclectic use of techniques and a group treatment modality that involves providing individual therapy within a group context. The core elements of the treatment are discussed and then exemplified in two case studies.

Personalized Medicine: Advanced Treatment Strategies to Revolutionize Healthcare.

Personalized medicine (PM) is about developing an individualized approach to each patient's illness. Understanding how a patient's genomic portfolio renders them prone to various diseases may be enhanced by discovering genetic, epigenetic, and medical evidence. Medical therapy that is safe and effective for specific individuals may be predicted using the PM approach, which is a complete expansion of an older methodology (One-Size-Fits-All). Patient's well-being and longevity may improve and costs are reduced if PM is used. Using existing biomarkers and early genome and epigenomic processes to better understand PM may lead to earlier diagnosis of the disease, including carcinogenesis. A key focus of the PM technique is preventative medicine, which emphasizes proactive actions rather than depending only on reactive ones. More intrusive procedures may be avoided or postponed using this technique, resulting in a higher quality of life and lower financial burdens for patients. End-of-life care costs are putting a strain on governmentfunded healthcare systems across the globe, notably in the United States. When used in conjunction with present treatments, PM may help them work better and lessen the disadvantages of just non-PM methods. Using genetic profiling, doctors may choose a drug based on a participant's genetic profile that minimizes unwanted side effects and ensures a better result while also being less costly than a 'trial-and-error' approach to sickness treatment. The less effective non- PM ('trial-and-error') strategy leads to drug toxicity, severe adverse effects, reactive treatment, and misdiagnosis. PM and proactive therapeutic regimens should be used more often to save costs and enhance overall well-being.

External validation of a clinical prediction model in multiple sclerosis.

BACKGROUND: Timely initiation of disease modifying therapy is crucial for managing multiple sclerosis (MS). OBJECTIVE: We aimed to validate a previously published predictive model of individual treatment response using a non-overlapping cohort from the Middle East. METHODS: We interrogated the MSBase registry for patients who were not included in the initial model development. These patients had relapsing MS or clinically isolated syndrome, a recorded date of disease onset, disability and dates of disease modifying therapy, with sufficient follow-up pre- and post-baseline. Baseline was the visit at which a new disease modifying therapy was initiated, and which served as the start of the predicted period. The original models were used to translate clinical information into three principal components and to predict probability of relapses, disability worsening or improvement, conversion to secondary progressive MS and treatment discontinuation as well as changes in the area under disability-time curve (ΔAUC). Prediction accuracy was assessed using the criteria published previously. RESULTS: The models performed well for predicting the risk of disability worsening and improvement (accuracy: 81%-96%) and performed moderately well for predicting the risk of relapses (accuracy: 73%-91%). The predictions for ΔAUC and risk of treatment discontinuation were suboptimal (accuracy < 44%). Accuracy for predicting the risk of conversion to secondary progressive MS ranged from 50% to 98%. CONCLUSION: The previously published models are generalisable to patients with a broad range of baseline characteristics in different geographic regions.

Multi-centre survey and analysis of individual therapy of antimicrobial agents in children / 中国药房

OBJECTIVE To investigate the development of individual therapy of antimicrobial agents in pediatric patients. METHODS A questionnaire survey was conducted to investigate the individual therapy of antimicrobial agents in 30 children’s hospitals and pediatric departments of general hospitals in China. The survey data was analyzed statistically by Microsoft Excel 2007 and SPSS 26.0 software. RESULTS In this survey， 75 questionnaires were collected， and 53 of them were valid with an effective rate of 70.7%. The results showed that 86.7% （26/30） of the hospitals carried out individual therapy of antimicrobial agents in different forms. Clinical needs primarily contributed to the individual therapy in these hospitals， while the insufficient personnel and equipment were the biggest obstacles for individual therapy. The proportions of hospitals， who implemented evidence- based pharmacy， therapeutic drug monitoring （TDM）， model-informed precision dosing （MIPD） and antimicrobial-related genetic tests were 70.0%， 80.0%， 30.0% and 33.3%， respectively. Various detection methods of TDM were carried out in various hospitals， and the antimicrobial agents which needed TDM focused on vancomycin and voriconazole. Moreover， nearly half of pharmacists did not know much about MIPD. CONCLUSIONS At present， TDM is the main way to develop individual therapy of antimicrobial agents in various hospitals， but its monitoring coverage and testing standards need to be improved. MIPD and antimicrobial-related gene tests still need to be further promoted in clinical practice.

Development of a Psychological Intervention to Improve Depressive Symptoms and Enhance Adherence to Antiretroviral Therapy among Adolescents and Young People Living with HIV in Dar es Salaam Tanzania.

Background: Interventions that simultaneously target depression and antiretroviral therapy (ART) medication adherence are recommended for improving HIV treatment outcomes and quality of life for adolescents living with HIV. However, evidence is scarce on culturally feasible and acceptable interventions that can be implemented for HIV-positive adolescents in Tanzania. We, therefore, developed a manualized brief psychological intervention that utilizes evidence-based strategies to address depression and ART adherence in adolescents living with HIV in Tanzania. Methods: We used the Theory of Change Enhanced Medical Research Council framework (TOCMRC) for developing complex interventions in health care to develop the intervention in five phases. First, the literature was reviewed to identify potential intervention components. Second, we conducted a situational analysis using qualitative interviews with adolescents living with HIV, health care providers, and caregivers. Third, we conducted a mental health expert workshop; and fourth, theory of change workshops with representatives from the Ministry of Health, mental health professionals, HIV implementing partners, adolescents, and healthcare providers. Lastly, we synthesized results to finalize the intervention and a theory of change map showing the causal pathway for how we expect the developed intervention to achieve its impact. Results: Adolescents living with HIV in Tanzania experience several unmet mental health needs ranging from overwhelming depressive symptoms to not feeling understood by healthcare providers who lack mental health knowledge. Participants perceived psychological intervention that utilizes a task-shifting approach to be acceptable and beneficial to addressing those problems. The novel components of the NITUE intervention included incorporating evidence-based intervention components, namely, cognitive-behavioral therapy, motivational interviewing, and problem solving. In addition, caregiver inclusion in the treatment was essential to ensure access to care, compliance, and improved outcomes. Conclusions: A culturally appropriate brief psychological intervention that utilizes a task-shifting approach to address depression and medication adherence for adolescents living with HIV in Dar es Salaam, Tanzania, was developed. The intervention will be piloted for appropriateness, feasibility, and acceptability and will provide material for a future trial to determine its effectiveness.

Personalized management of dyslipidemias in patients with diabetes-it is time for a new approach (2022).

Dyslipidemia in patients with type 2 diabetes (DMT2) is one of the worst controlled worldwide, with only about 1/4 of patients being on the low-density lipoprotein cholesterol (LDL-C) target. There are many reasons of this, including physicians' inertia, including diabetologists and cardiologists, therapy nonadherence, but also underusage and underdosing of lipid lowering drugs due to unsuitable cardiovascular (CV) risk stratification. In the last several years there is a big debate on the risk stratification of DMT2 patients, with the strong indications that all patients with diabetes should be at least at high cardiovascular disease (CVD) risk. Moreover, we have finally lipid lowering drugs, that not only allow for the effective reduction of LDL-C and do not increase the risk of new onset diabetes (NOD), and/or glucose impairment; in the opposite, some of them might effectively improve glucose control. One of the most interesting is pitavastatin, which is now available in Europe, with the best metabolic profile within statins (no risk of NOD, improvement of fasting blood glucose, HOMA-IR, HbA1c), bempedoic acid (with the potential for the reduction of NOD risk), innovative therapies-PCSK9 inhibitors and inclisiran with no DMT2 risk increase, and new forthcoming therapies, including apabetalone and obicetrapib-for the latter one with the possibility of even decreasing the number of patients diagnosed with prediabetes and DMT2. Altogether, nowadays we have possibility to individualize lipid lowering therapy in DMT2 patients and increase the number of patients on LDL-C goal without any risk of new onset diabetes and/or diabetes control worsening, and in consequence to reduce the risk of CVD complications due to progression of atherosclerosis in this patients' group.

Efficacy of second-line ICIs combined with TKIs among patients with metastatic renal cell carcinoma: a real-world study.

Aim: To evaluate the efficacy of immune checkpoint inhibitors (ICIs) plus tyrosine kinase inhibitors (TKIs) as second-line treatment in patients with metastatic renal cell carcinoma (mRCC). Patients & methods: Baseline and follow-up data from patients with mRCC treated with second-line ICIs plus TKIs or TKIs alone from a single institution were retrospectively gathered. Results: A total of 110 patients were included. The objective response rate was higher among patients treated with ICIs plus TKIs than those treated with TKIs alone (36.5 vs 12.1%; p = 0.002). Treatment with ICIs plus TKIs was associated with longer progression-free survival (15.0 vs 9.0 months; p = 0.009) and overall survival (not reached vs 16.0 months; p = 0.018) than TKI monotherapy. The survival rates at 2 (83.0 vs 74.4%; p = 0.426) and 3 years (58.1 vs 47.5%; p = 0.214) between the two groups were not statistically different. Notably, patients with certain clinicopathological features tended to gain more survival benefits with combined therapy. Conclusion: ICIs plus TKIs showed superior progression-free survival time and tumor response rate over TKIs alone as second-line treatment in patients with mRCC. Future randomized prospective trials are necessary to validate these preliminary findings.

Aim: To evaluate the efficacy of immune checkpoint inhibitors (ICIs) combined with tyrosine kinase inhibitors (TKIs) in patients with previously treated metastatic renal cell carcinoma (mRCC). Patients & methods: Data at initial treatment and follow-up of patients with mRCC with second-line ICIs plus TKIs or TKIs alone were documented. Results: A total of 110 patients were included. The tumor shrinkage rate was higher among patients treated with ICIs plus TKIs than those treated with TKIs alone. Patients receiving ICIs plus TKIs had delayed disease progression and longer survival time compared with patients treated with TKI monotherapy. However, patients had a similar probability of survival after 2 and 3 years of treatment. Notably, patients with certain clinicopathological characteristics gained more survival benefits from ICIs plus TKIs. Conclusion: ICIs plus TKIs showed superior efficacy over TKIs alone in previously treated patients with mRCC. Future randomized prospective trials are necessary to validate these preliminary findings.

Internet based intervention (Emotion Regulation Individual Therapy for Adolescents) as add-on to treatment as usual versus treatment as usual for non-suicidal self-injury in adolescent outpatients: The TEENS randomised feasibility trial.

Background: Non-suicidal self-injury (NSSI) is common in adolescents receiving psychiatric treatment and is a significant risk factor for suicidal behavior. There are few randomised clinical trials assessing interventions for NSSI in youth, and knowledge about internet-delivered interventions is limited. Objective: We assessed the feasibility of Internet based Emotion Regulation Individual Therapy for Adolescents (ERITA) in psychiatric outpatients aged 13-17 years who engaged in NSSI. Method: A randomised clinical feasibility trial with a parallel group design. Non-suicidal self-injury engaging patients were recruited from Child and Adolescent Mental Health Outpatient Services in the Capital Region of Denmark from May to October 2020. ERITA was provided as add-on to treatment as usual (TAU). ERITA is a therapist-guided, internet-based program of emotion regulation and skills training involving a parent. The control intervention was TAU. Feasibility outcomes were the proportion who completed follow-up interviews at end of intervention; proportion of eligible patients who participated in the trial; proportion of participants completing ERITA. We further investigated relevant exploratory outcomes, including adverse risk-related events. Results: We included 30 adolescent participants, 15 in each group (ERITA vs. Treatment as usual). 90% (95% CI, 72%-97%) of the participants completed post-treatment interviews; 54% (95% CI, 40%-67%) of the eligible participants were included and randomised; and 87% (95% CI, 58%-98%) of the participants completed at least six out of 11 ERITA modules. We identified no difference for the primary exploratory clinical outcome of NSSI between the two groups. Conclusion: There are few randomised clinical trials assessing interventions for NSSI in youth, and knowledge about internet-delivered interventions is limited. Based on our results we conclude that a large-scale trial seems feasible and warranted.

Multicenter randomized controlled trial of the effects of individual reminiscence therapy on cognition, depression and quality of life: Analysis of a sample of older adults with Alzheimer's disease and vascular dementia.

Objective: To determine the effectiveness of a 13-week individual reminiscence therapy (RT) intervention on cognition, memory, executive function, mood, and quality of life of people with Alzheimer's disease and vascular dementia. Method: Non-protocolized analysis using data from a larger multicenter, single-blind, randomized, parallel two-arm RCT of RT for people with neurocognitive disorders. A sample of 148 people with probable Alzheimer's disease or vascular dementia attending 23 Portuguese institutions providing care and support services for older adults were selected. Intervention group (n = 74) received 26 individual RT sessions, twice a week for 13 weeks. Control group (n = 74) maintained their treatment as usual. Outcomes were global cognitive function (MMSE), memory (MAT), executive function (FAB), mood (GDS-15), and self-reported quality of life (QoL-AD). All participants were assessed at baseline (T0) and 15 weeks later (T1). Results: The results showed a significant effect of the intervention on global cognition (Group X Time interaction F(1, 128) = 10.542, p = .001, ηp2 = .076), memory (F(1,128) = 9.881, p = .002, ηp2 = .072), and quality of life (F(1,128) = 0.181, p = .671, ηp2 = .001), with medium effect sizes. A small effect on executive function (F(1,127) = 11.118, p = .001, ηp2 = .080) was also found. No effects were found on depressive symptoms (F(1,128) = 0.181, p = .671, ηp2 = .001). Conclusion: Individual RT may have beneficial effects on cognition and quality of life of people with Alzheimer's disease or vascular dementia.

A Deep-Learning Model With the Attention Mechanism Could Rigorously Predict Survivals in Neuroblastoma.

BACKGROUND: Neuroblastoma is one of the most devastating forms of childhood cancer. Despite large amounts of attempts in precise survival prediction in neuroblastoma, the prediction efficacy remains to be improved. METHODS: Here, we applied a deep-learning (DL) model with the attention mechanism to predict survivals in neuroblastoma. We utilized 2 groups of features separated from 172 genes, to train 2 deep neural networks and combined them by the attention mechanism. RESULTS: This classifier could accurately predict survivals, with areas under the curve of receiver operating characteristic (ROC) curves and time-dependent ROC reaching 0.968 and 0.974 in the training set respectively. The accuracy of the model was further confirmed in a validation cohort. Importantly, the two feature groups were mapped to two groups of patients, which were prognostic in Kaplan-Meier curves. Biological analyses showed that they exhibited diverse molecular backgrounds which could be linked to the prognosis of the patients. CONCLUSIONS: In this study, we applied artificial intelligence methods to improve the accuracy of neuroblastoma survival prediction based on gene expression and provide explanations for better understanding of the molecular mechanisms underlying neuroblastoma.

An Internet-based emotion regulation intervention versus no intervention for non-suicidal self-injury in adolescents: a statistical analysis plan for a feasibility randomised clinical trial.

BACKGROUND: Non-suicidal self-injury (NSSI) has a lifetime prevalence of 17% in adolescents in the general population and up to 74% in adolescents with psychiatric disorders. NSSI is one of the most important predictors of later suicidal behaviour and death by suicide. The TEENS feasibility trial was initiated to assess the feasibility and safety of Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA) as an add-on to treatment as usual in 13-17-year-old patients with NSSI referred to the Child and Adolescent Mental Health Services. METHODS: The TEENS feasibility trial is a randomised clinical trial with a parallel-group design. The trial intervention is an 11-week online therapy which is tested as an add-on to treatment as usual versus treatment as usual. The primary feasibility outcomes are the fraction of participants who (1) completed 12 weeks of follow-up interview or assessment, (2) consented to inclusion and randomisation out of all eligible participants, and (3) were compliant with the experimental intervention, assessed as completion of at least six out of eleven modules in the programme. Since this is a feasibility trial, we did not predefine a required sample size. The exploratory clinical outcome, the frequency of NSSI episodes, assessed using Deliberate Self-Harm Inventory - Youth version (DSHI-Y), at the end of intervention, is planned to be the future primary outcome in a larger pragmatic definitive randomised clinical trial. After completion of the feasibility trial, blinded data will be analysed by two independent statisticians blinded to the intervention, where 'A' and 'B' refer to the two groups. A third party will compare these reports, and discrepancies will be discussed. The statistical report with the analyses chosen for the manuscript is being tracked using a version control system, and both statistical reports will be published as a supplementary material. Based on the final statistical report, two blinded conclusions will be drawn by the steering group. DISCUSSION: We present a pre-defined statistical analysis plan for the TEENS feasibility trial, which limits bias, p-hacking, data-driven interpretations. This statistical analysis plan is accompanied by a pre-programmed version-controlled statistical report with simulated data, which increases transparency and reproducibility. TRIAL REGISTRATION: ClinicalTrials.gov NCT04243603 . Registered on 28 January 2020.

Experiences of an Online Treatment for Adolescents With Nonsuicidal Self-injury and Their Caregivers: Qualitative Study.

BACKGROUND: Nonsuicidal self-injury (NSSI) is common in adolescence and is associated with several adverse outcomes. Despite this, few established treatment options exist. Online treatment seems promising for several conditions; however, knowledge on NSSI is scarce. It is important to explore how online treatment for NSSI is experienced to improve such interventions and learn more about factors that are important in the treatment of adolescents with NSSI. OBJECTIVE: This study aims to explore the experiences of a novel online treatment for adolescents with NSSI and their caregivers. METHODS: A qualitative study using thematic analysis was conducted through semistructured interviews with 9 adolescents and 11 caregivers at treatment termination or at the 6-month follow-up of the online emotion regulation individual therapy for adolescents. RESULTS: A total of 3 overarching themes were identified. The theme support can come in different shapes showed how support could be attained through both interaction with the therapist as well as through the format itself (such as through the fictional characters in the material and the mobile app). Caregivers found it helpful to have their own online course, and adolescents accepted their involvement. The theme self-responsibility can be empowering as well as distressing showed that self-responsibility was highly appreciated (such as deciding when and how to engage in treatment) but also challenging; it caused occasional distress for some. The theme acquiring new skills and treatment effects showed the advantages and challenges of learning several different emotion regulation skills and that decreased emotion regulation difficulties were important treatment outcomes for adolescents. In addition, several different skills seemed to facilitate emotion regulation, and having access to such skills could hinder NSSI. CONCLUSIONS: Online emotion regulation individual therapy for adolescents seems to offer an accepted way to deliver family interventions for this target group; facilitate skills training with several means of support, including support from both the mobile app and the therapist; contribute to decreasing emotion regulation difficulties and teaching skills that could hinder NSSI; and cause (in some individuals) distress because of the self-responsibility that is inherent to online formats, which needs to be addressed.

Perceived helpfulness of depression treatments among young adults with autism.

Currently available treatments for depression show limited effectiveness in adults with autism spectrum disorders (ASD) based on measures of symptom changes and clinician impressions. Perceived helpfulness is another metric that has been found to be useful for understanding treatment outcomes in the general population, but it has not yet been explored in adults with ASD. Thus, the current study collected online survey data to examine patient-perceived treatment helpfulness in a sample of 144 adults with ASD who reported that they were currently receiving community-based treatment for depression. Findings indicate that while there was variability in the levels of perceived helpfulness for both medication and individual therapy, most adults with ASD perceived treatment to be at least moderately helpful. Notably, adults with ASD reported having been in treatment for a prolonged duration (5 to 6 years). Ordinal logistic regression models showed that adults with more depressive symptoms perceived treatments to be less helpful (i.e., medications: odds ratio [OR] = 0.92, 95% confidence interval[CI] = 0.89-0.95; individual therapy: OR = 0.95, 95% CI = 0.92-0.99). Moreover, women perceived medication as more helpful than men (OR = 2.33, 95% CI = 1.13-4.82). Other individual (i.e., age, race, education level) and treatment (i.e., treatment length, concurrent treatment) characteristics were not significantly associated with perceived helpfulness. These findings suggest that future studies may want to use perceived helpfulness, in addition to traditionally used objective outcomes, to understand patients' treatment experience and evaluate depression treatments for adults with ASD. LAY SUMMARY: Adults with autism are much more likely to be depressed than those without autism; therefore, effective depression treatments are necessary to improve mental health outcomes in this group. This online survey study found that most adults with autism felt that the depression treatments they were receiving in the community (i.e., medication and individual therapy) were helpful. Females and those with fewer symptoms of depression felt treatments were more helpful compared with males and those with more symptoms of depression. Our findings suggest that when examining whether treatments for depression are effective, it may be important to measure adults' feelings about the helpfulness of the treatments in addition to measuring changes in symptoms of depression.