Novel 3-arm wait-list controlled trial designs together with mixed-effects analysis improve precision of treatment effect estimators.

Clinical trialists have long been searching for approaches to increase statistical power without increasing sample size. Conventional wait-list controlled (WLC) trials are limited to two trial arms and two or three repeated measurements per person. These features limit statistical power. Furthermore, their analysis is usually based on analysis of covariance or mixed effects modelling, with a focus on estimating treatment effect at one time-period after initiation of therapy. We propose two 3-arm WLC trial designs together with a mixed-effects analysis framework. The designs require three or four repeated measurements per person. The analytic framework defines up to three treatment effect estimands, representing the effects at one to three time-periods after initiation of therapy. The precision (inverse of variance) of the treatment effect estimators in the new and conventional trial designs are analytically derived and evaluated in simulations. The results are interpreted in the context of a cognitive training trial in older people. The proposed designs and analysis methods increase the precision level of treatment effect estimators as compared to conventional designs and analyses. Given a target level of statistical power, the proposed methods require a smaller number of participants per trial than the conventional methods, without necessarily increasing the number of measurements per trial. Furthermore, the proposed analytic framework sheds light on the treatment effects at different times after initiation of therapy, which is not usually considered in conventional WLC trial analysis. In situations that a WLC trial is appropriate, the 3-arm designs are useful alternatives to existing 2-arm designs.

The Emergency Medical Services Sleep Health Study: A cluster-randomized trial.

BACKGROUND: Greater than half of emergency medical services (EMS) clinician shift workers report poor sleep, fatigue, and inadequate recovery between shifts. We hypothesized that EMS clinicians randomized to receive tailored sleep health education would have improved sleep quality and less fatigue compared to wait-list controls after 3 months. METHODS: We used a cluster-randomized, 2-arm, wait-list control study design (clinicaltrials.gov identifier: NCT04218279). Recruitment of EMS agencies (clusters) was nationwide. Our study was powered at 88% to detect a 0.4 standard deviation difference in sleep quality with 20 agencies per arm and a minimum of 10 individuals per agency. The primary outcome was measured using the Pittsburgh Sleep Quality Index (PSQI) at 3-month follow-up. Our intervention was accessible in an online, asynchronous format and comprised of 10 brief education modules that address fatigue mitigation topics prescribed by the American College of Occupational Environmental Medicine. RESULTS: In total, 36 EMS agencies and 678 individuals enrolled. Attrition at 3 months did not differ by study group (Intervention = 17.4% vs. Wait-list control = 18.2%; p = .37). Intention-to-treat analyses detected no differences in PSQI and fatigue scores at 3 months. Per protocol analyses showed the greater the number of education modules viewed, the greater the improvement in sleep quality and the greater the reduction in fatigue (p < .05). CONCLUSIONS: While intention-to-treat analyses revealed no differences in sleep quality or fatigue at 3 months, per protocol findings identified select groups of EMS clinician shift workers who may benefit from sleep health education. Our findings may inform fatigue risk management programs.

An Evaluation of Whole-School Trauma-Informed Training Intervention Among Post-Primary School Personnel: A Mixed Methods Study.

Students' ability to reach their potential in school-both behaviourally and academically - is linked to their educator's knowledge of child and adolescent development, childhood adversity and trauma, and how these impact learning and behaviour. However, teacher pre-service training programmes often offer inadequate instruction to meet the needs of trauma-impacted students. The purpose of the study was to investigate the benefits of professional development training in trauma-informed approaches on school personnel attitudes and compassion fatigue. There is a paucity of research on whole-school trauma-informed approaches and most have methodological limitations via the absence of a control group. In addressing this gap, the study is one of the first to utilise a control group in the research design to ensure findings are robust. The study utilised a quasi-experimental wait-list control pre-post intervention design to evaluate the efficacy of trauma-informed professional development training. We compared attitudes and compassion fatigue among 216 school personnel (n = 98 intervention, n = 118 comparison) utilising the Attitudes Related to Trauma-Informed Care (ARTIC) scale and the Professional Quality of Life scale (Pro-QoL). Quantitative data was supplemented by qualitative focus group data. Findings demonstrated that school-personnel within the intervention group reported significant improvements in attitudes related to trauma-informed care, and a significant decrease in burnout at 6-month follow-up. Our findings demonstrate that with minimum training on the dynamics of trauma, personnel attached to a school can become more trauma-informed and have more favourable attitudes towards trauma-impacted students and consequently be less likely to experience burnout.

An adaptive method for assigning clinical trials wait-times for controls.

Wait-list control clinical trials are popular among psychologists and rehabilitation specialists partly because all participants receive the intervention. In 2 arm wait-list control trials, individuals randomized to the treatment group receive immediate treatment whereas individuals randomized to the control group wait a fixed amount of time before intervention is initiated. For interventions that have varying durations, careful consideration must be given to the period that participants in the control group have a delay until treatment begins, as incongruent wait times compared to the intervention durations of the treatment group may introduce confounding into the evaluation of the treatment differences. To alleviate this issue, we propose to adaptively assign wait times to individuals randomized to the control group based on the intervention duration of those in the treatment group. Simulations demonstrate the that our method not only results in similar timing distributions between participants in the treatment and control groups, but also allows participants in the control group to initiate treatment earlier than the traditional design. The latter characteristic may reduce dropout and result in more efficient study enrollment.

Increasing engagement with an occupational digital stress management program through the use of an online facilitated discussion group: Results of a pilot randomised controlled trial.

INTRODUCTION: Rates of work-related stress, depression and anxiety are high, resulting in reduced work performance and absenteeism. There is evidence that digital mental health interventions delivered in the workplace are an effective way of treating these conditions, but intervention engagement and adherence remain a challenge. Providing guidance can lead to greater engagement and adherence; an online facilitated discussion group may be one way of providing that guidance in a time efficient way. This study compares engagement with a minimally guided digital mental health program (WorkGuru) delivered in the workplace with a discussion group (DG) and without a discussion group (MSG), and with a wait list control (WLC); it was conducted as a pilot phase of a definitive trial. METHODS: Eighty four individuals with elevated levels of stress from six organisations were recruited to the study and randomised to one of two active conditions (DG or MSG) or a WLC. The program WorkGuru is a CBT based, eight-week stress management intervention that is delivered with minimal guidance from a coach. Data was collected at baseline, post-intervention and at 16-week follow-up via online questionnaires. The primary outcome measure was number of logins. Secondary measures included further engagement measures, and measures of depression, anxiety, stress, comfort and enthusiasm. Quality measures including satisfaction and system usability were also collected. RESULTS: A greater number of logins was observed for the DG compared with the MSG; this was a medium between group effect size (d = 0.51; 95% CI: - 0.04, 1.05). Small to medium effect size differences were found at T2 in favour of the active conditions compared with the control on the DASS subscales depression, anxiety and stress, and the IWP subscales enthusiasm and comfort. This was largely maintained at T3. Satisfaction with the intervention was high with individuals in the MSG reporting greater satisfaction than individuals in the DG. CONCLUSIONS: This study shows that access to an online facilitated discussion group increases engagement with a minimally supported occupational digital mental health intervention (as defined by the number of logins), but that this doesn't necessarily result in improved psychological outcomes or increased satisfaction when compared to access to the intervention without the group. Access to the web-based program was associated with lower levels of depression, anxiety and stress and an increase in comfort and enthusiasm post intervention; these changes were largely maintained at follow-up. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov on March the 18th 2016 NCT02729987 (website link https://clinicaltrials.gov/ct2/show/NCT02729987?term=NCT02729987&rank=1).