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Control groups used in randomised controlled trials investigating psychological interventions for depression and anxiety disorders have effects of their own. This has never been investigated for schizophrenia, in particular treatment-resistant schizophrenia. This systematic review and meta-analysis aimed to examine how control groups in randomised controlled trials on psychological interventions for treatment-resistant schizophrenia behave in their effects on general symptomatology. In a search of various databases until July 2023, 31 eligible studies with 3125 participants were found whose control groups were assigned to four categories: active, inactive, treatment as usual and waitlist. The analyses showed that psychological interventions had a greater effect on symptom reduction to all control groups combined. When separating the control groups, only compared to TAU and waitlist controls the psychological interventions were superior. The difference was larger when less active control groups (e.g. waitlist - or treatment as usual control groups) were used. All control groups were associated with an improvement in symptoms from pre- to post-measurement point, with the greatest improvement observed in the inactive control group. The results are preliminary, but they suggest that the choice of the control group has a considerable impact on study effects as it has been shown in other psychiatric diagnoses.

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OBJECTIVE: Persistent physical symptoms (PPS) represent a major health problem affecting daily functioning. This RCT aimed to examine whether a guided Internet-based treatment based on acceptance and commitment therapy (ACT) provided additional benefits compared to Treatment as Usual (TAU) in reducing somatic complaints and psychological distress in adults with PPS. METHODS: A total of 103 adults with PPS related to indoor environments, chronic fatigue or both conditions were assigned to receive either either a 14-week intervention (video-based case conceptualization + Internet-based ACT) combined with TAU (iACT + TAU; n = 50) or TAU alone (n = 53). Somatic symptoms, depression, anxiety, insomnia, and psychological flexibility were assessed from pre-intervention to a 3-month follow-up. Additionally, the association between changes in psychological flexibility from pre- to post-intervention and changes in symptoms from pre to 3-month follow-up was explored. Analyses were conducted using a multigroup method with full information maximum likelihood estimator. RESULTS: The results revealed a significant interaction effect, indicating reductions in somatic symptoms and symptoms of depression and anxiety with moderate to large between-group effects (d = 0.71-1.09). No significant interaction effect was observed in insomnia and measures of psychological flexibility. CONCLUSION: Internet-based ACT, when combined with Treatment as Usual, demonstrated efficacy for individuals with PPS associated with indoor environments and chronic fatigue. These findings are pertinent for primary healthcare providers, suggesting that the current treatment model could serve as a low-threshold first-line treatment option. THE CLINICAL TRIAL REGISTRATION NUMBER: NCT04532827.

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Background and objective: Cognitive-behavioral therapy (CBT) for somatoform disorders (SFDs) is understudied in China. Western findings may not be applicable to Chinese culture. This preliminary study evaluated the efficacy of CBT for patients in China, relative to treatment-as-usual (TAU). Methods: Seventy patients with SFDs randomly received either combined CBT and TAU (CBT + TAU), or TAU alone between January 2018 to May 2019. The CBT + TAU group received 12 weekly individual 50-minute CBT sessions. Participants were blindly assessed at 4 timepoints (baseline, week 6, end of treatment: week 12; 12 weeks post-treatment: week 24) using the following outcome measures: SQSS (Self-screening Questionnaire for Somatic Symptoms); PHQ-15 (Patient-Health-Questionnaire-15) and the WI (Whiteley Index); GAD-7 (General Anxiety Disorder-7); HAMD-17 (Hamilton Depression Rating Scale-17); Family Burden Interview Schedule (FBIS); Sheehan Disability Scale (SDS); and the Short Form of Quality-of-Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF). The primary endpoint was the difference between the SQSS total score at week 24 and the baseline. A mixed model for repeated measures was used to analyze inter- and intra-group changes from the baseline. Results: At week 24, The least-squares mean (LSM) change of the total score on the SQSS was -18.87 points and -9.69 points, respectively in the CBT + TAU group and in the TAU group (LSM difference, -9.18 points; 95% confidence interval, -15.72 to -2.64; P = 0.0068). At week 24, the LSM changes from baseline in the WI, HAMD, PHQ15, FBIS and SDS total scores were significantly different between the two groups, however, there was no significant difference in the Q-LES-Q-SF. The SQSS of group effect sizes were 0.63 at 24 weeks. The dropout rates of the CBT + TAU and TAU groups were comparable (22.9% and 19.3%). Conclusions: These preliminary findings suggest that CBT may be helpful for improving the symptoms of patients with SFDs in China.

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There is a knowledge gap regarding clinically representative therapy given in routine settings, that is treatment as usual (TAU), for patients with common mental health problems (CMHP). This review and meta-analysis aimed to investigate what characterizes clinically representative therapy in Nordic routine clinics and meta-analyze the outcome of such treatment. Databases (PubMed, EMBASE, PsychINFO, and SveMed+) were searched for TAU, CMHP, and Nordic countries, together with backward and forward search in Scopus (7 November 2022). Studies were either randomized controlled trials (RCT) or open trials, using prospective study designs, examining heterogeneous outpatient groups in routine treatment. Within- and between-group effect sizes (ES), using random effects model, and moderator analyses were calculated. Eleven studies (n = 1,413), demonstrated a small to moderate within-group ES with high heterogeneity (g = 0.49, I2 = 90%). ESs in RCTs were significantly smaller than in open trials. TAU had a marginally smaller ES (g = -0.21; adjusted for publication bias g = -0.06) compared to a broad set of clinical interventions. Clinically representative therapy in the Nordic countries demonstrated a wide variety of characteristics and also a marginally lower ES compared to other interventions. The ESs were smaller than other meta-analyses examining evidence-based treatments in routine treatment.

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Objective: Little is known about the effects of routine mental health care on return-to-work (RTW) outcomes. This systematic review aimed to summarize and evaluate the effects of clinical representative psychotherapy on RTW among patients with a common mental disorder (CMD), treated within public mental health care. Method: A systematic search was conducted using PubMed, PsycINFO, Embase, and SveMED+. Primary outcomes were RTW, sick leave status, or self-reported work functioning. Studies limited to specific treatments and/or specific patient groups were excluded. Results: Out of 1,422 records, only one article met the preregistered inclusion criteria. After broadening of criteria, a total of nine studies were included. Six were randomized controlled trials (RCT), two were register-based studies, and one was a quasi-experimental study. Descriptions of treatment duration and intensity of usual care were rarely specified but ranged from a few sessions to 3 years of psychotherapy. In the RCTs, two studies favored the intervention, one favored routine care, and three found no difference between conditions. Choice of outcomes differed greatly and included RTW rates (full or partial), number of days until RTW, change in sick leave status, and net days/months of work absence. Time points for outcome assessment also varied greatly from 3 months to 5 years after treatment. Conclusion: There is inconclusive evidence to establish to what extent routine mental healthcare is associated with improved RTW outcomes for patients with CMD. There is a need for more and better clinical trials and naturalistic studies detailing the content of routine treatment and its effect on RTW. Systematic review registration: This study was pre-registered at PROSPERO (CRD42022304967), https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022304967.

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Couple therapy has outperformed control conditions in randomized clinical trials (RCTs). However, there have been some questions whether couple treatment in naturalistic settings is as effective as those with more rigorous controls. The current meta-analysis examined 48 studies of couple therapy in non-randomized clinical trials. The pre-post effect size was Hedge's g = 0.522 for relational outcomes and Hedge's g = 0.587 for individual outcomes. However, there was significant heterogeneity in the results. Several moderators explained some of the variance in these estimates. For relationship outcomes, studies who had older couples and longer length of relationship had better outcomes. Studies with a higher percentage of racial/ethnic minority (REM) couples and studies in Veteran Affairs Medical Centers (VAMC) had lower relational outcomes. For individual outcomes, studies that had more sessions, older couples, and VAMC had better outcomes. Studies with a higher percentage of REM couples also had worse individual outcomes. Trainee status was not consistently related to relational or individual outcomes. Implications for research and practice are provided.

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BACKGROUND: Collaborative care (CC) could improve outcomes in primary care patients with common mental conditions. We assessed the effectiveness of a transdiagnostic model of telephone-based CC (tCC) delivered by lay providers to primary care patients with depression, anxiety, or at-risk drinking. METHODS: PARTNERS was a pragmatic trial in 502 primary care adults presenting with depressive symptoms, anxiety symptoms, or at-risk drinking randomized to (1) usual care by primary care providers (PCPs) enhanced with the results of computer-assisted telephone-based assessments (at baseline and 4, 8, and 12 months later) (enhanced usual care [eUC]) or (2) tCC consisting of eUC plus frequent telephone coaching and psychoeducation provided by mental health technicians who also communicated to the PCP recommendations from a psychiatrist for evidence-based pharmacotherapy, psychotherapy, or, when indicated, referrals to mental health services. The primary analysis compared the change on the 9-item Patient Health Questionnaire (PHQ-9) in participants presenting with depression (n = 366) randomized to tCC versus eUC. Secondary analyses compared changes on the Generalized Anxiety Disorder-7 scale (GAD-7) in those presenting with anxiety (n = 298); or change in the number of weekly drinks in those presenting with at-risk drinking (n = 176). RESULTS: There were no treatment or time×treatment effects between tCC and eUC on PHQ-9 scores for patients with depression during the 12-month follow-up. However, there was a treatment effect (tCC > eUC) on GAD-7 scores in those with anxiety and a time×treatment interaction effect on the number of weekly drinks (tCC > eUC) in those with at-risk drinking. CONCLUSION: Implementing transdiagnostic tCC for common mental disorders using lay providers appears feasible in Canadian primary care. While tCC was not better than eUC for depression, there were some benefits for those with anxiety or at-risk drinking. Future studies will need to confirm whether tCC differentially benefits patients with depression, anxiety, or at-risk drinking.

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Background: Improving children's access to mental health services need more innovative solutions, especially in low- and middle-income countries. School-based psychosocial interventions delivered by lay counselors may be an efficient way to improve children's access to mental health services. But few studies were conducted to examine the effectiveness of these interventions. Therefore, this study is to evaluate the effectiveness of trauma-focused cognitive behavioral therapy (TF-CBT) in a group format delivered by lay counselors to children with trauma-related symptoms in China. Methods: A total of 234 children (aged 9-12 years) with full or subthreshold posttraumatic stress disorder (PTSD) were randomly assigned to group-based TF-CBT or treatment as usual (TAU). In the intervention group, 118 children received 10-12 sessions of group-based TF-CBT delivered by lay counselors for 9 consecutive weeks. In the TAU group, 116 children received the usual school services provided by psychology teachers. The primary outcome was the reduction in PTSD severity, which was assessed with the UCLA PTSD reaction index for DSM-5 (PTSD-RI-5). The secondary outcomes included the reduction in PTSD severity and the remission of PTSD, both of which were measured with the PTSD checklist-5 (PCL-5). Secondary outcomes also included the reduction in depression severity and the reduction in generalized anxiety severity. Blinded assessments were collected at baseline, posttreatment (primary endpoint), and 3-month follow-up. This trial is registered with Chinese Clinical Trial Registry, ChiCTR1900027131. Findings: At posttreatment, the intervention group scored significantly lower than the TAU group on PTSD-RI-5 PTSD (30.98 vs. 39.22; adjusted mean difference [AMD], -7.35; 95% CI, -11.66 to -3.04), PCL-5 PTSD (28.78 vs. 38.04; AMD, -8.49; 95% CI, -13.23 to -3.75), depression (5.52 vs. 7.96; AMD, -1.63; 95% CI, -2.50 to -0.76), and generalized anxiety (7.23 vs. 8.64; AMD, -1.21; 95% CI, -2.20 to -0.23). The remission of PCL-5 PTSD was also significantly higher in the intervention group (42.86% vs. 13.54%, χ 2  = 13.10, P < 0.001). These two groups showed a similar level of symptoms at the 3-month follow-up. Interpretation: The group-based TF-CBT can significantly alleviate PTSD, depression, and generalized anxiety right after treatment in Chinese children who suffer from different types of trauma. But the long-term effects of this intervention need to be further tested. This intervention can be delivered by trained lay counselors in low- and middle-income countries. Funding: None.

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BACKGROUND: In randomized controlled trials (RCTs) within medical research, applied interventions are compared to treatment-as-usual (TAU) as the control condition. The aim of the current study was to examine how the concept of TAU is described when used as control condition in RCTs evaluating treatments for depression, anxiety syndromes, and stress-related mental disorders in primary care. METHOD: A systematic review of RCTs utilizing TAU as control group in the RCT in accordance with PRISMA standards was conducted. We used one multidisciplinary database (Scopus), one database focused on nursing (Cinahl), and one medical database (PubMed). The searches were conducted in November 2021 and May 2022. RESULTS: The included 32 studies comprised of 7803 participants. The content of TAU was classified as follows: 1) Basic descriptions of TAU lacking a detailed account as well as reference to local or national guidelines, 2) Moderate description of TAU including reference to national or local guidelines or a detailed description 3) Advanced description of TAU including references to national guidelines and a detailed description containing five key concepts: early assessment, accessibility, psychological treatment, medication, somatic examination. 18 studies had basic, 11 moderate, and 3 advanced descriptions of TAU. LIMITATIONS: The limitations were that only studies published in English were included. CONCLUSIONS: The current study provides an assessment tool with three classification levels for TAU. The description of TAU is still insufficient in RCT studies conducted in primary care, which may affect the interpretation of results. In future research a detailed description of TAU is recommended.

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Goal Management Training (GMT) improved self-reported executive functioning in a recent randomized, controlled trial in early intervention for psychosis participants. Little is known about the mechanism for this benefit, so this study investigates objectively measured executive function, the difference between subjective and objective executive function, independent living and employment status as potential moderators of efficacy of GMT. Baseline scores from 81 participants (GMT n = 39 vs Treatment-as-usual; TAU n = 42) were analyzed in a linear mixed model analysis for repeated measures as predictors of improvement on the self-reported Behavior Rating Inventory of Executive Function-Adult version (BRIEF-A) immediately and 30 weeks after GMT. Potential moderators were scores from objective measures of executive functioning, discrepancy between subjective and objective measures, independent living and employment status. Discrepancy was assessed by comparing four clusters of participants with differing patterns of scores. The effect of GMT remained significant regardless of initial objective executive functioning at baseline. Those with higher subjective complaints at baseline in two clusters with (i) both objective and subjective executive dysfunction, and (ii) mostly subjective executive dysfunction experienced greater change after treatment. Living arrangements or participation in education or work did not significantly moderate the effects of GMT. Poor performance on neuropsychological tasks is not an obstacle to making use of GMT, but further knowledge is needed about the benefits of strategy training for individuals with a combination of poor performance with few subjective complaints.

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Publicly funded initiatives are underway to improve implementation of evidence-based practices (EBP) in youth mental health services. However, we know little about the success of these initiatives or about EBP implementation independent of such initiatives. We examined EBP implementation in a treatment as usual (TAU) state and in six states with publicly funded EBP initiatives (EBPIs). In Study 1, we examined providers' use of practices derived from the evidence base (PDEB) and their predictors among 780 providers in a TAU state. In Study 2, we conducted a systematic review of implementation strategies, outcomes, and predictors of EBP use in six state funded EBPIs. Study 1 suggests TAU providers use PDEB alongside practices without consistent research support; provider racial/ethnic minority status, learning theory orientation, and manual use predict greater PDEB use. Study 2 indicates EBPIs employ multiple recommended implementation strategies with variable outcomes across studies and measurement approaches. Predictors of EBP use in EBPIs also varied, though training, setting, and youth age were consistent predictors across studies. While sample differences and inconsistent measurement across studies made direct comparisons somewhat tenuous, rates of PDEB use in the TAU sample appeared similar to those in publicly funded EBPIs. However, two states reported comparisons with TAU samples and found higher EBP implementation under EBPI. Different predictors impacted EBP use in TAU versus EBPIs. Our findings highlight the need for improved evaluation of EBPIs including clear reporting standards for outcomes and more consistent, standardized measurement of EBP use in order to better understand and improve EBPIs.

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Background: Patients with opioid use disorder (OUD) have a significant problem in psychosocial functioning domains, which are not systematically studied in India. This study aimed to evaluate the psychosocial functioning in current noninjecting opioid users on Methadone Maintenance Treatment (MMT) versus Treatment as Usual (TaU: Chlordiazepoxide, Zolpidem, Trazodone, Tramadol, Tapentadol, and Buprenorphine). Materials and Methods: It is a cross-sectional study on patients of current noninjecting OUD on MMT or TaU for at least in the past month. Comorbidities and illness severity were assessed with the help of Mini-International Neuropsychiatric Interview 7.0.2 and World Health Organization-The Alcohol, Smoking, and Substance Involvement Screening Test 3.0, respectively. Social and occupational functioning assessment scale (SOFAS), WHO Quality of Life (WHOQoL-BREF), and Client Satisfaction Questionnaire (CSQ-8) assessed the sociooccupational functioning and QoL and client satisfaction. A total of 67 participants (37 on MMT and 30 on TaU) were included in the study. Results: A significant difference between the two groups (MMT better than TaU) was based on SOFAS scores, CSQ-8, and WHOQoL-BREF. In the TaU group, there was a significant negative correlation between risk of addiction severity with sociooccupational functioning (r = -0.5; P = 0.0046), physical health (r = -0.48; P = 0.0087) and social relationship (r = -0.47; P = 0.0087) domain of QoL. In the MMT group, the association between risk of addiction severity with sociooccupational functioning, domains of QoL, and client satisfaction were insignificant. Conclusion: Sociooccupational Functioning, Client Satisfaction, and QoL of patients maintained on MMT are better than those on TaU.

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Few studies have compared the effectiveness of internet-based cognitive behavior therapy (ICBT) for obsessive-compulsive disorder (OCD) with treatment as usual (TAU). We investigated the effectiveness of guided ICBT for patients with OCD. This prospective, randomized, controlled, assessor-blinded, multicenter clinical trial was conducted at three facilities in Japan from January 2020 to March 2021. Thirty-one patients with OCD as the primary diagnosis participated in the trial and were randomly assigned to either the intervention group or the control group. The primary outcome was the Yale-Brown obsessive-compulsive scale score; the assessors were blinded. Results of the analysis of covariance among the groups were significantly different between the groups (p < 0.01, effect size Cohen's d = 1.05), indicating the superiority of guided ICBT. The results suggest that guided ICBT is more effective than TAU for treating OCD. RCT REGISTRATION: UMIN Clinical Trials Registry (UMIN000039375).

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INTRODUCTION: Treatment as usual (TAU) is the most frequently used control group in randomized trials of psychotherapy for depression. Concerns have been raised that the heterogeneity of treatments in TAU leads to biased estimates of psychotherapy efficacy and to an unclear difference between TAU and control groups like waiting list (WL). OBJECTIVE: We investigated the impact of control group intensity (i.e., amount and degree to which elements of common depression treatments are provided) on the effects of face-to-face and internet-based psychotherapy for depression. METHODS: We conducted a preregistered meta-analysis (www.osf.io/4mzyd). We included trials comparing psychotherapy with TAU or WL in patients with symptoms of unipolar depression. Six indicators were used to assess control group intensity. PRIMARY OUTCOME: Standardized mean difference (SMD) of psychotherapy and control in depressive symptoms at treatment termination. RESULTS: We included 89 trials randomizing 14,474 patients to 113 psychotherapy conditions and 89 control groups (TAU in 42 trials, WL in 47 trials). Control group intensity predicted trial results in preregistered (one-sided ps < 0.042) and exploratory analyses. Psychotherapy effects were significantly smaller (one-sided p = 0.002) in trials with higher intensity TAU (SMD = 0.324, CI 0.209 to 0.439) than in trials with lower intensity TAU (SMD = 0.628, CI 0.455 to 0.801). Psychotherapy effects against lower intensity TAU did not differ from effects against WL (two-sided p = 0.663). CONCLUSIONS: Our results suggest that variation in TAU intensity impacts the outcome of trials. More scrutiny in the design of control groups for clinical trials is recommended.

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BACKGROUND: For anorexia nervosa, firm evidence of the superiority of specialized psychological treatments is limited and economic evaluations of such treatments in real world settings are scarce. This consecutive cohort study examined differential (cost-)effectiveness for adult inpatients and outpatients with anorexia nervosa, after implementing cognitive behavioral therapy-enhanced (CBT-E) throughout a routine setting. METHODS: Differences in remission, weight regain and direct eating disorder treatment costs were examined between one cohort (N = 75) receiving treatment-as-usual (TAU) between 2012-2014, and the other (N = 88) CBT-E between 2015-2017. The economic evaluation was performed from a health care perspective with a one-year time horizon, using EDE global score < 2.77, the absence of eating disorder behaviors combined with a BMI ≥ 18.5, as effect measure. Incremental cost-effectiveness ratios were calculated and cost-effectiveness planes and cost-effectiveness acceptability curves were displayed to assess the probability that CBT-E is cost effective compared to TAU. RESULTS: Using direct eating disorder treatment costs in the cost-effectiveness analysis, the cost-effectiveness plane of the base case scenario for all patients indicated a 84% likelihood of CBT-E generating better health gain at additional costs. The median ICER is €51,081, indicating a probable preference for CBT-E (> 50% probability of cost-effectiveness) assuming a WTP of €51,081 or more for each additional remission, On remission, no difference was found with 9.3% remission during TAU and 14.6% during CBT-E (p = .304). Weight regain was higher during CBT-E (EMD = 1.33 kg/m2, SE = .29, 95% CI [0.76-1.9], p < .001). CONCLUSIONS: In this mixed inpatient and outpatient cohort study, findings indicate a probability of CBT-Ebeing more effective at higher costs. These findings may contribute to the knowledge of effectiveness and cost-effectiveness of specialized psychological treatments. In this study, the effectiveness and treatment costs of a specialized psychological treatment for adult clients with anorexia nervosa were compared with a regular, non-specialist treatment. One group of inpatients and outpatients did receive non-specialist treatment, the next group of inpatients and outpatients received CBT-E, a specialized treatment, later on. CBT-E is recommended for clients with bulimia and with binge eating disorder, for clients with anorexia nervosa it is less clear which specialized psychological treatment should be recommended. Results indicate that at end-of-treatment, CBT-E was not superior on remission. When looking at weight regain, CBT-E seemed superior than the treatment offered earlier. Economic evaluation suggests that CBT-E generates better health gain, but at additional costs. This study contributes to the knowledge on the effectiveness and treatment costs of psychological treatments, as they are offered in routine practice, to adults with anorexia nervosa.

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INTRODUCTION: Clinical trials typically involve random assignment to treatment conditions. However, random assignment does not guarantee a lack of systematic variation in the outcomes, and application of covariation methods for multiple dependent measures requires complicated assumptions that are often not met. METHODS: This study employed matched correspondence analysis (CA) for controlling systematic variation and handling multiple outcomes. One hundred nine children with autism spectrum disorder (ASD) were assessed for anxiety symptom severity across four studies, where participants were randomly assigned to either cognitive behavioral therapy (CBT) or treatment as usual or waitlist (TAU/WT). Matched CA is designed to optimally scale only the differences between baseline and posttreatment, rendering the systematic baseline carryover effects irrelevant. RESULTS: Differences in treatment efficacy were observed. CBT showed treatment efficacy on anxiety severity and anxiety-related impairment relative to TAU/WT, after the control of baseline carryover effects. CONCLUSION: This study provides a way to control systematic variation between groups at the outset of treatment trials and is expected to provide a novel pathway to more proper assessment of treatment efficacy for children with ASD and anxiety.

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BACKGROUND: About 30% of children with autism spectrum disorder (ASD) do not develop functional speech and remain non-verbal or minimally verbal even after years of speech, language and educational interventions. A wide range of interventions have been developed for improving communication in ASD, but none have proved effective in eliciting functional language in ASD children. Research has found that people with ASD are more likely to have perfect pitch and prefer music to language. Further, it seems that language delay tends to co-occur with better musical skills. Brain imaging research has found that music alongside words increases the attention that people with ASD pay to spoken words. METHODS: In this protocol, we describe our music-assisted programmes (MAP) that will use music to attract the attention of people with ASD to speech. MAP may open the brain pathways to language and therefore help improve communication skills for people with ASD more than standard communication protocols. In particular, we aim to develop and test whether individualised, easily used MAP would increase spoken language in 24-60-month-old, nonverbal or minimally verbal children with ASD. We will develop a structured training method, delivered through naturalistic, interactive activities (e.g. songs) to teach language to ASD children. We will test this by comparing two groups: one undertaking music-assisted programmes, and the other receiving speech and language therapy in the way that is recommended in NHS clinics. Participants will be allocated to groups randomly. The feasibility of MAP will be assessed through estimations of recruitment and retention rates, the sensitivity and reliability of the outcome measures, the intensity and frequency of the trial, the usability of the MAP app (beta version), and the burden of the assessments for the children and parents. DISCUSSION: This feasibility randomised controlled trial will establish the acceptability and estimate the power of the MAP intervention to improve early word learning in children with ASD. In the longer term, this research will help us develop an app for parents or carers of children with ASD to design their own songs and implement their own individualised MAP. TRIAL REGISTRATION: ISRCTN, ISRCTN12536062 . Registered on 26 June 2019.

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Patients with schizophrenia, a severe chronic disorder, are characterized by resistance to therapy, lack of disease understanding, non-compliance and non-adherence, partly caused and maintained by an often poorly structured treatment strategy and polypharmacy. Treatment pathways in the sense of decision aids for professionals bring recommendations from guidelines into a clear and practice-oriented algorithm that can be a helpful tool for treatment. The aim of the present study was to assess the impact of a newly developed electronic clinical pathway (CPW) that integrates the standard computerized medical report system on symptomatic outcomes and process parameters in a population of inpatients with schizophrenia. In this randomized single-center study, 156 patients with schizophrenic disorder were treated in two groups: an experimental CPW group and a control "treatment as usual" (TAU) group. The treatment improvement was analyzed using various process parameters: the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression scale (CGI), the Personal and Social Performance scale (PSP) and the Nurses' Observation Scale for Inpatient Evaluation (NOSIE). The CPW patients differentially showed greater improvement in psychopathology (PANSS) compared to TAU patients (t(154) = 2.030, p = 0.044). There also seems to be advantage for CPW concerning improvement in NOSIE. These results indicate a positive influence of CPW on the quality of treatment and support its implementation in daily clinical practice.

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Biopsychosocial intervention has been suggested as a complementary treatment strategy for patients with chronic conditions. We compared the effect of a mind-body intervention (MBI), relative to treatment-as-usual (TAU) on WHO-5 Well-being Index during an intensive period of 12 weeks and follow-up at week 26 among patients with either psoriasis (PsO) or rheumatoid arthritis (RA). The MBI was based on the 'Relaxation Response Resiliency Program' and the 'Open and Calm Program', as well as 'Mindfulness Based Stress Reduction' (MBSR). The trial was randomized, management-as-usual, and controlled. Statistical analyses were based on the intention-to-treat population using repeated measures and mixed effects models (NCT03888261). We screened 39 potential participants, 35 of which (PsO, n = 20; RA, n = 15) met the eligibility criteria and were randomized: 17 in the MBI group and 18 in the TAU group. Attrition from the intervention program was 19%, with 65% of MBI patients and 71% of TAU patients completing the outcome assessments. After 12 weeks, a statistically significant difference in WHO-5 was observed between the groups (p = 0.019). However, according to the protocol, during the entire trial period, the average (least squares mean values) WHO-5 score was higher although not statistically significant in the MBI group (65.3) compared with the TAU group (59.1), corresponding to a between-group difference over 26 weeks of 6.15 (95% CI: -0.26 to 12.56; p = 0.060). All things considered, adding biopsychosocial intervention to clinical practice to patients with conditions, such as PsO and RA, could potentially improve health-related quality of life.

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The incidence of Neonatal Abstinence Syndrome (NAS) continues to rise and there remains a critical need to develop non-pharmacological interventions for managing opioid withdrawal in newborns. Objective physiologic markers of opioid withdrawal in the newborn remain elusive. Optimal treatment strategies for improving short-term clinical outcomes and promoting healthy neurobehavioral development have yet to be defined. This dual-site randomized controlled trial (NCT02801331) is designed to evaluate the therapeutic efficacy of stochastic vibrotactile stimulation (SVS) for reducing withdrawal symptoms, pharmacological treatment, and length of hospitalization, and for improving developmental outcomes in opioid-exposed neonates. Hospitalized newborns (n = 230) receiving standard clinical care for prenatal opioid exposure will be randomly assigned within 48-hours of birth to a crib with either: 1) Intervention (SVS) mattress: specially-constructed SVS crib mattress that delivers gentle vibrations (30-60 Hz, ~12 µm RMS surface displacement) at 3-hr intervals; or 2) Control mattress (treatment as usual; TAU): non-oscillating hospital-crib mattress. Infants will be studied throughout their hospitalization and post discharge to 14-months of age. The study will compare clinical measures (i.e., withdrawal scores, cumulative dose and duration of medications, velocity of weight gain) and characteristic progression of physiologic activity (i.e., limb movement, cardio-respiratory, temperature, blood-oxygenation) throughout hospitalization between opioid-exposed infants who receive SVS and those who receive TAU. Developmental outcomes (i.e., physical, social, emotional and cognitive) within the first year of life will be evaluated between the two study groups. Findings from this randomized controlled trial will determine whether SVS reduces in-hospital severity of NAS, improves physiologic function, and promotes healthy development.