Using stepped-care approaches within internet-based interventions for youth anxiety: Three case studies.

Background There are a lack of clear guidelines for the dissemination of Internet-based cognitive behaviour therapy (ICBT) for childhood and adolescent anxiety in routine care. While self-guided ICBT has greater reach than therapist-guided ICBT, it is plagued by problems of low program adherence and many young people are not successfully treated. It is important that we identify models of ICBT that are accessible, but provide the right support, at the right time to those who need it. Stepped-care models of ICBT offer one potential solution. Objective This case study examined the application of stepped-care within an ICBT intervention for childhood and adolescent anxiety, in which young people were stepped up from self-guided to therapist-guided ICBT. Methods Three case studies are presented and include young males (aged 11–12 years) who participated in BRAVE Stepped-Care, a new ICBT program incorporating two treatment steps: Step 1 – five sessions of self-guided ICBT and Step 2 – five sessions of therapist-guided ICBT. Participants completed diagnostic assessments at pre- and post-treatment, along with a battery of self-report questionnaires. Step-up requirements were determined at a mid-treatment assessment. Treatment response was determined by change on diagnostic severity and presence of diagnosis and changes in self-reported anxiety symptoms (through T-scores and Reliable Change Indices). Results In-depth examination of the three case studies showed that decisions to step-up from Step 1 to Step 2 were complex and required consideration of program engagement and adherence, as well as changes on self-reported anxiety, behavioural indicators of anxiety and parent perspectives. Results showed that non-responders at mid-treatment who were stepped-up to therapist-guided ICBT after Step 1 were able to increase engagement and response to treatment in Step 2, such that they were free of their primary anxiety diagnosis at post-treatment. Conclusions The findings highlight the importance of early assessment of engagement and non-response within self-guided ICBT programs for youth anxiety and the positive changes that can subsequently occur when therapist-guidance is introduced mid-treatment for non-responders. The efficacy of stepped-care ICBT models needs to be confirmed in larger randomised controlled trials

Efficacy of an internet-based CBT program for children with comorbid High Functioning Autism Spectrum Disorder and anxiety: a randomised controlled trial

Background All trials conducted to date on BRAVE-ONLINE for youth anxiety disorders have excluded children with High Functioning Autism Spectrum Disorder (HFASD) and therefore it is unknown whether these programs might be beneficial to HFASD children. The aim of this study was to evaluate the efficacy of BRAVE-ONLINE in HFASD children with an anxiety disorder. Methods Forty-two HFASD children, aged 8–12 years, with an anxiety disorder, and their parents, were randomly assigned to either the BRAVE-ONLINE condition (NET) or a waitlist control (WLC). Diagnostic interviews and parent/child questionnaires were completed at pre-treatment, post-treatment and 3-month follow-up. Results At post- assessment, compared to children in the WLC condition, children in the NET condition demonstrated a significantly greater reduction in number of anxiety diagnoses, clinical severity of diagnosis, and self and parent reported anxiety symptoms, as well as significantly greater increases in overall functioning. However, loss of primary diagnosis in this sample was lower than in previous studies. Limitations The small sample size, coupled with attrition rates, makes it difficult to generalise the findings of the study to HFASD population and to conduct analyses regarding mediators, moderators and predictors of outcomes. Conclusions The BRAVE-ONLINE program may be useful in reducing anxiety symptoms in HFASD children, although the effects are less strong than those found in neurotypical children for a variety of reasons

The evolution of climate change guidance for fluvial flood risk management in England

Floods are one of the biggest natural hazards to society, and there is increasing concern about the potential impacts of climate change on flood occurrence and magnitude. Furthermore, flood risk is likely to increase in the future not just through increased flood occurrence, but also through socio-economic changes, such as increasing population. The extent to which adaptation measures can offset this increased risk will depend on the level of future climate change, but there exists an urgent need for information on the potential impacts of climate change on floods, so that these can be accounted for by flood management authorities and local planners aiming to reduce flood risk. Agencies across the UK have been pro-active in providing such guidance for many years and in refining it as the science of climate change and hydrological impacts has developed. The history of this guidance for fluvial flood risk in England is presented and discussed here, including the recent adoption of a regional risk-based approach. Such an approach could be developed and applied to flood risk management in other countries, and to other sectors affected by climate change

Effects of Acute Vaporized Nicotine in Non-tobacco Users at Rest and During Exercise

Smokers, and even non-smokers, may utilize vaporized nicotine delivered by electronic cigarette (EC) due to the perception that EC are “healthier” than traditional tobacco cigarettes. The effects of vaporized nicotine delivered by EC on resting blood pressure (BP) and metabolic rate (RMR), or BP and aerobic power during exercise have not been studied. This investigation tested the effects of acute vaporized nicotine inhalation by EC on resting BP and RMR and cycle exercise BP, metabolic responses, and aerobic power in young, normotensive non-smokers. Using a double-blind design, 20 subjects (10 female; 23.1±2.5 years, 1.69±0.1 m, 70.6±14.9 kg; 22.1±11.0% body fat) self-reporting as healthy and non-smoking participated. All subjects participated in two randomized trials: placebo (0 mg nicotine) or nicotine (18 mg nicotine). Participants inhaled from EC once every 30 s for 10 min (20 inhalations total) during each trial. RMR was assessed 40 min later by indirect calorimetry followed by an incremental cycle test. Participants’ pre-inhalation SBP, DBP, and HR were also not significantly different between conditions or from those averaged over the last 5 min of the indirect calorimetry protocol. Cotinine, a stable nicotine metabolite, was assessed on post-inhalation (i.e., 10 min) urine samples. The cotinine concentration ranges, as scored using the semi-quantitative urine analysis kit strips, were significantly higher (p-1) compared to placebo (0-10 ng•ml-1). RMR was assessed ~40 min after the last EC inhalation. RMR (p=0.39), VO2 (p=0.5), RQ (p=0.15), and HR (p=0.47) were not significantly different between the placebo and nicotine trials. Compared to the placebo trial, nicotine use resulted in a 3.7 mmHg lower resting SBP (p=0.04) but a 3.0 mmHg higher DBP (p=0.04). VO2peak was not different between the nicotine trial (2.3±0.8 L•min-1) and placebo trial (2.3±0.7 L•min-1) trials (p=0.77). No statistically distinguishable difference was observed for Wpeak between nicotine (201.0±53.8 W) and placebo (204.8±57.8 W) (p=0.29). There was a main effect of time over the cycle test for VO2 , energy expenditure, RQ, and HR but no between treatment effects. A main treatment effect was identified for DBP, which was higher following nicotine compared to placebo at all time points during the test (p=0.05). No time by treatment interaction was identified for any variable during exercise. Exercise DBPpeak after nicotine (79.4±7.6) was significantly higher (p=0.02) than placebo (74.9±8.3 mmHg). Peak SBP was not different between trials (p=0.14). Our results show that acute vaporized nicotine inhalation via EC increases resting and exercise DBP but does not affect RMR or cycle aerobic power in young, normotensive non-smokers

Understanding students’ motivation towards proactive career behaviours through goal-setting theory and the job demands–resources model

The graduate labour market is highly competitive but little is known about why students vary in their development of employability. This study contributes to the literature by applying goal-setting theory and the job demands–resources model to investigate how motivational processes influence students’ proactive career behaviours. We tested four hypotheses using structural equation modelling and moderation/mediation analysis using a nested model approach; 432 undergraduates from 21 UK universities participated in this cross-sectional study. The results showed that students higher in mastery approach had greater perceived employability mediated by two proactive career behaviours (skill development and network building). Students’ career goal commitment was associated with all four proactive career behaviours (career planning, skill development, career consultation and network building). Students’ academic and employment workloads did not negatively impact their proactive career behaviours. University tutors and career services should therefore encourage students to set challenging career goals that reflect mastery approach

Intensive Group-Based CBT for Child Social Phobia: A Pilot Study

Objective: Although CBT has proven efficacious in the treatment of child social phobia (SP), most children do not present for treatment and child SP may be less responsive to treatment than other anxiety disorders. Intensive, group-based, SP-specific CBT may improve the efficacy of, and access to, treatment for child SP. The aim of this study was to provide a preliminary examination of such a program. Method: Forty Australian children aged 7-12. years (15 male and 25 female) were allocated into treatment and waitlist groups. Clinical interviews to determine diagnostic status were conducted prior to treatment, following treatment and at 6-month follow-up. Parent and child questionnaire measures of child anxiety symptoms, internalizing symptoms, depression, social skills, social competence, and parental social anxiety were administered at the same time points. Treatment was delivered in 4 separate 3-hour sessions conducted over 3 consecutive weekends. Results: At postassessment, 52.4% of children in the treatment group and 15.8% of children in the waitlist group were free of their SP diagnosis. At postassessment, compared to waitlist children, treatment group children demonstrated a greater drop in clinical severity, a greater increase in overall functioning, and held fewer clinical diagnoses. Treatment group children also reported a greater reduction in SP symptoms compared to waitlist children, and treatment group parents reported a greater reduction in child internalizing and anxiety symptoms, a greater increase in child social competence, and a greater decrease in parental SP symptoms, compared to parents of children in the waitlist group. By 6-month follow-up, 76.9% of the treatment group were free of their SP diagnosis and gains on all other measures were maintained. Conclusions: The results of this study are encouraging, and suggest that brief, intensive, group CBT for children with social anxiety is beneficial for many youngsters

Large-scale dissemination of internet-based cognitive behavioral therapy for youth anxiety: feasibility and acceptability study

Background: Internet-based cognitive behavioral therapy (iCBT) for child and adolescent anxiety has demonstrated efficacy in randomized controlled trials, but it has not yet been examined when disseminated as a public health intervention. If effective, iCBT programs could be a promising first-step, low-intensity intervention that can be easily accessed by young people. Objective: The objective of our study was to examine the feasibility and acceptability of a publicly available online, self-help iCBT program (BRAVE Self-Help) through exploration of program adherence, satisfaction, and changes in anxiety. Methods: This study was an open trial involving the analysis of data collected from 4425 children and adolescents aged 7-17 years who presented with elevated anxiety at registration (baseline) for the iCBT program that was delivered through an open-access portal with no professional support. We assessed the program satisfaction via a satisfaction scale and measured adherence via the number of completed sessions. In addition, anxiety severity was assessed via scores on the Children’s Anxiety Scale, 8-item (CAS-8) at four time points: baseline, Session 4, Session 7, and Session 10. Results: Participants reported moderate satisfaction with the program and 30% completed three or more sessions. Statistically significant reductions in anxiety were evident across all time points for both children and adolescents. For users who completed six or more sessions, there was an average 4-point improvement in CAS-8 scores (Cohen d=0.87, children; Cohen d=0.81, adolescents), indicating a moderate to large effect size. Among participants who completed nine sessions, 57.7% (94/163) achieved recovery into nonelevated levels of anxiety and 54.6% (89/163) achieved statistically reliable reductions in anxiety. Conclusions: Participant feedback was positive, and the program was acceptable to most young people. Furthermore, significant and meaningful reductions in anxiety symptoms were achieved by many children and adolescents participating in this completely open-access and self-directed iCBT program. Our results suggest that online self-help CBT may offer a feasible and acceptable first step for service delivery to children and adolescents with anxiety

Training recruiters to randomized trials to facilitate recruitment and informed consent by exploring patients' treatment preferences

BACKGROUND: Patients’ treatment preferences are often cited as barriers to recruitment in randomized controlled trials (RCTs). We investigated how RCT recruiters reacted to patients’ treatment preferences and identified key strategies to improve informed decision-making and trial recruitment. METHODS: Audio-recordings of 103 RCT recruitment appointments with 96 participants in three UK multicenter pragmatic RCTs were analyzed using content and thematic analysis. Recruiters’ responses to expressed treatment preferences were assessed in one RCT (ProtecT - Prostate testing for cancer and Treatment) in which training on exploring preferences had been given, and compared with two other RCTs where this specific training had not been given. RESULTS: Recruiters elicited treatment preferences similarly in all RCTs but responses to expressed preferences differed substantially. In the ProtecT RCT, patients’ preferences were not accepted at face value but were explored and discussed at length in three key ways: eliciting and acknowledging the preference rationale, balancing treatment views, and emphasizing the need to keep an open mind and consider all treatments. By exploring preferences, recruiters enabled participants to become clearer about whether their views were robust enough to be sustained or were sufficiently weak that participation in the RCT became possible. Conversely, in the other RCTs, treatment preferences were often readily accepted without further discussion or understanding the reasoning behind them, suggesting that patients were not given the opportunity to fully consider all treatments and trial participation. CONCLUSIONS: Recruiters can be trained to elicit and address patients’ treatment preferences, enabling those who may not have considered trial participation to do so. Without specific guidance, some RCT recruiters are likely to accept initial preferences at face value, missing opportunities to promote more informed decision-making. Training interventions for recruiters that incorporate key strategies to manage treatment preferences, as in the ProtecT study, are required to facilitate recruitment and informed consent. TRIAL REGISTRATION: ProtecT RCT: Current Controlled Trials ISRCTN20141297. The other two trials are registered but have asked to be anonymized

Optimising recruitment and informed consent in randomised controlled trials:the development and implementation of the QuinteT Recruitment Intervention (QRI)

BACKGROUND: Pragmatic randomised controlled trials (RCTs) are considered essential to determine effective interventions for routine clinical practice, but many fail to recruit participants efficiently, and some really important RCTs are not undertaken because recruitment is thought to be too difficult. The ‘QuinteT Recruitment Intervention’ (QRI) aims to facilitate informed decision making by patients about RCT participation and to increase recruitment. This paper presents the development and implementation of the QRI. METHODS: The QRI developed iteratively as a complex intervention. It emerged from the National Institute for Health Research (NIHR) ProtecT trial and has been developed further in 13 RCTs. The final version of the QRI uses a combination of standard and innovative qualitative research methods with some simple quantification to understand recruitment and identify sources of difficulties. RESULTS: The QRI has two major phases: understanding recruitment as it happens and then developing a plan of action to address identified difficulties and optimise informed consent in collaboration with the RCT chief investigator (CI) and the Clinical Trials Unit (CTU). The plan of action usually includes RCT-specific, as well as generic, aspects. The QRI can be used in two ways: it can be integrated into the feasibility/pilot or main phase of an RCT to prevent difficulties developing and optimise recruitment from the start, or it can be applied to an ongoing RCT experiencing recruitment shortfalls, with a view to rapidly improving recruitment and informed consent or gathering evidence to justify RCT closure. CONCLUSIONS: The QRI provides a flexible way of understanding recruitment difficulties and producing a plan to address them while ensuring engaged and well-informed decision making by patients. It can facilitate recruitment to the most controversial and important RCTs. QRIs are likely to be of interest to the CIs and CTUs developing proposals for ‘difficult’ RCTs or for RCTs with lower than expected recruitment and to the funding bodies wishing to promote efficient recruitment in pragmatic RCTs. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1391-4) contains supplementary material, which is available to authorized users

Measuring research impact: a large cancer research funding programme in Australia

Background: Measuring research impact is of critical interest to philanthropic and government funding agencies interested in ensuring that the research they fund is both scientifically excellent and has meaningful impact into health and other outcomes. The Beat Cancer Project (BCP) is a AUD $34 m cancer research funding scheme that commenced in 2011. It was initiated by an Australian charity (Cancer Council SA), and supported by the South Australian Government and the state’s major universities. Methods: This study applied Buxton and Hanney’s Payback Framework to assess research impact generated from the BCP after 3 years of funding. Data sources were an audit of peer-reviewed publications from January 2011 to September 2014 from Web of Knowledge and a self-report survey of investigators awarded BCP research funding during its first 3 years of implementation (2011–2013). Of the 104 surveys, 92 (88 Results: The BCP performed well across all five categories of the Payback Framework. In terms of knowledge production, 1257 peer-reviewed publications were generated and the mean impact factor of publishing journals increased annually. There were many benefits to future research with 21 respondents (23$1 that the cancer charity invested, the BCP gained an additional AUD $6.06. Five projects (5%) had informed policy and 5 (5%) informed product development, with an additional 31 (34%) and 35 (38%) projects, respectively, anticipating doing so. In terms of health and sector and broader economic benefits, 8 (9%) projects had influenced practice or behaviour of health staff and 32 (34%) would reportedly to do so in the future. Conclusions: Research impact was a priority of charity and government funders and led to a deliberate funding strategy. Emphasising research impact while maintaining rigorous, competitive processes can achieve the joint objectives of excellence in research, yielding good research impact and a high rate of leverage for philanthropic and public investment, as indicated by these early results