Wild 2018.

Study name	Public title: A study of resilience training for student paramedics Scientific title: Preventing PTSD, depression, and associated health problems in student paramedics: a randomised controlled trial of internet‐delivered cognitive training for resilience (iCT‐R)
Methods	Study design: RCT Study grouping: parallel group Unit of randomisation: individuals Power (power sample size calculation, level of power achieved): Setting power at 80%, α = 0.05 and hypothesising a reduction of relative risk of 50% gives an Odds Ratio of 0.429, which requires a total sample size of 304 to show a risk reduction of 50% between internet‐delivered cognitive training for resilience (iCT‐R) and the alternative intervention. Thus, each condition would require 152 participants. Since we have a third condition (standard practice), the total sample size required would be 456. Allowing for a 20% rate of attrition, we will require a total sample size of 570 Imputation of missing data: potential method of imputation not specified; data analysis will be intention‐to‐treat; all participants who have been randomised will be included in analyses, including those who drop out
Participants	Country: UK Setting: online interventions Age: not specified in trial registration or study protocol Sample size (randomised): 570 targeted Sex: not specified Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified Population description: student paramedics Inclusion criteria: see trial registration and study protocol (Wild 2018): 1) aged 18 and above (until 65 years); 2) training to be paramedics and in years 1, 2 or 3 of student paramedic training; 3) access to internet; 4) willing to be randomly allocated Exclusion criteria: see trial registration and study protocol (Wild 2018): 1) current symptoms of PTSD or MD, including suicidal ideation, requiring treatment (participants excluded if symptoms are interfering with their lives and they would like treatment; (score ≥ 10 on PHQ‐9); score on PHQ‐9 suicidal ideation item ≥ 1; Post‐traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th edition (PCL‐5): ≥ 33) Attrition (withdrawals and exclusions): not specified Reasons for missing data: not specified
Interventions	Intervention: iCT‐R: n randomised not specified) delivery: supported online intervention; imagery component, practice of strategies that have been shown to prevent stress‐related responses from developing, attention training and monthly top‐up exercises during follow‐up to consolidate training providers: trained online coach (research assistant) provides email feedback on students’ responses and, through an automated short message service (SMS) programme, sends regular brief reminders of key points and notifications to practice if‐then plans duration of treatment period and timing: main phase of course: 6 weeks with 6 sessions; monthly top‐up exercises during follow‐up to consolidate training description: aims to modify rumination and appraisals linked to low resilience core information delivered in 6 modules (include whiteboard videos to explain concepts, audio files for practising concrete thinking, testimonies from qualified paramedics and video footage of student paramedic call‐outs for use in experiential exercises; participants regularly reminded to practice concrete thinking) modules: it matters what you focus on: helpful and unhelpful attention get out of your head with helpful thinking habits and dwelling: how to change them feeling with unwanted memories: then versus now transforming worries and improving performance beating stress and trauma: my blueprint compliance: not specified integrity of delivery: not specified economic information: not specified theoretical basis: cognitive training Control 1: attention control mind‐online resilience intervention (already available intervention; n randomised not specified) delivery: online intervention; see above providers: see above; same frequency, type and duration of remote support as in iCT‐R duration of treatment period and timing: 6 modules (6 weeks) description: Participants receive the same frequency, type and duration of remote support as in iCT‐R 6 modules available online covering information and advice about stress, sleep problems, anger, depression, PTSD and mindfulness compliance: not specified integrity of delivery: not specified economic information: not specified theoretical basis: not specified Control 2: TAU/wait‐list control (n randomised not specified) delivery: not specified for TAU providers: not specified; provided to students as part of university programme duration of treatment period and timing: not specified description: standard practice: access to usual support offered through university, but no online modules or remote support information on well‐being and stress participants are offered iCT‐R at the end of follow‐up compliance: not specified integrity of delivery: not specified economic information: not specified theoretical basis: not specified
Outcomes	Outcomes collected and reported: Primary outcome: diagnoses of PTSD and MD ‐ Structured Clinical Interview for DSM‐5 – PTSD and MD modules PTSD and MD symptomatology ‐ PCL‐5; PHQ‐9 Secondary outcomes: resilience ‐ CD‐RISC and RS rumination ‐ RRS (brooding subscale) and dwelling subscale of RIQ responses to intrusive memories ‐ RIQ anxiety symptoms ‐ GAD‐7 smoking and alcohol use ‐ Smoking Behaviour Questionnaire; Alcohol Use Questionnaire weight and height ‐ Weight and Height Questionnaire, unpublished; BMI sleep quality and duration ‐ ISI psychological distress ‐ GHQ well‐being ‐ WEMWS hormone function, levels of cortisol ‐ assay analysis on samples collected upon awakening, 15, 30, and 60 minutes after awakening, and at 12 noon and 8 pm); radio‐immunoassay analysis immune function, high sensitivity C‐reactive protein levels ‐ enzyme‐linked immunosorbent assay in fasting serum samples collected quality‐adjusted life years ‐ EuroQol 5 Dimensions questionnaire costs associated with psychiatric illness ‐ Trimbos/iMTA (Institute for MedicalTechnology Assessment) Questionnaire for Costs associated with Psychiatric Illness; Client Service Receipt Inventory; Health and Labour Questionnaire Tertiary outcomes (see study protocol Wild 2018): neuroticism ‐ Eysenck Personality Questionnaire neuroticism subscale social support ‐ Social Support scale adapted from a brief measure of social support demographics ‐ General information questionnaire trauma exposure ‐ Trauma screener concrete thinking ‐ concrete thinking questionnaire, adapted from a previous concrete thinking assessment intrusions ‐ duration, frequency and distress linked to Intrusions Questionnaire Outcomes reported not specified Time points measured and reported: 1) pre‐intervention; 2) post‐intervention (i.e. 6 weeks); 3) 6‐month follow‐up (i.e. 6 months after intervention); 4) 1‐year follow‐up (i.e. 1 year after intervention); 5) 2‐year follow‐up (i.e. 2 years after intervention); diagnoses of PTSD and MD: all outcomes except 6‐month follow‐up; PTSD and MD symptomatology: all time points; secondary and tertiary outcomes: all time points except 6‐month follow‐up except for demographics (only pre‐intervention, 1‐year and 2‐year follow‐up); time points reported not specified Adverse events: not specified
Starting date	Study start/end date: January 2016; ‐January 2021
Contact information	Principal investigator: Dr Jennifer Wild Address: Department of Experimental Psychology; University of Oxford; Oxford Centre for Anxiety Disorders and Trauma, Oxford OX1 1TW, United Kingdom Email: jennifer.wild@psy.ox.ac.uk Telephone: +44 1865 618 612
Notes	Contact with authors: no correspondence required Funding source: sponsor: University of Oxford funding: This work is funded by an MQ: Transforming Mental Health grant (number CQR01260) and supported by the NIHR Oxford Health Biomedical Research Centre.MQ had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data or decision to submit results. AE is funded by a Wellcome Trust Principal Research Fellowship (grant 200796). CP is supported by the NIHR Biomedical Research Centre at the South London and Maudsley NHS Trust and King’s College London, London, UK. Declaration of interest: see study protocol (Wild 2018): Jennifer Wild, Anke Ehlers and their team have developed iCT‐R. They do not receive any income from this work Ethical approval needed/obtained for study: Ethical approval of the research protocol was gained from The Medical Sciences Inter‐Divisional Research Ethics Committee at the University of Oxford, 17 August 2017, ref: R44116/RE001 Comments by study authors: trial registration number ISRCTN16493616 (assigned 9 October 2017) Miscellaneous outcomes by the review authors: according to trial registration, the study is no longer recruiting but the overall trial status is ongoing; intention to publish September 2021 (last updated October 2017)

Abbreviations common to all tables:

α: significance level; β: statistical power; BADS: Behavioural Activation for Depression Scale; BASS: Beliefs About Stress Scales; BDI: Beck Depression Inventory; BMI: body mass index; BRS: Brief Resilience Scale; CD‐RISC: Connor‐Davidson Resilience Scale; CEQ: Capability and Expectancy Questionnaire; CES‐D: Center for Epidemiology Studies‐ Depression; CG: control group; d: delta (Cohen's d, effect size); IG: intervention group; GAD‐7: Generalised Anxiety Disorder scale; GHQ: General Health Questionnaire; iCT‐R: internet‐delivered cognitive training for resilience; ISI: Insomnia Severity Index; ITT: intention‐to‐treat analysis; MBI: Maslach Burnout Inventory; MBSR: mindfulness‐based stress reduction; MD: major depression; n: sample size (e.g. in respective study group); OBI: Oldenburg Burnout Inventory; PCL‐5: Post‐traumatic stress disorder Check List for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition; PHQ: Patient Health Questionnaire; PSS: Perceived Stress Scale; PSS: Presenteeism Scale for Students; PTSD: post‐traumatic stress disorder; RCT: randomised controlled trial; RIQ: Response to Intrusions Scale; RRS: Ruminative Response Scale; RS: Resilience Scale; RSES: Rosenburg Self‐Esteem Scale; SCS: Self‐Compassion Scale; SD: standard deviation; SMS: short message service; STAI: State‐Trait Anxiety Inventory; TAU: Treatment as usual; VAS: Visual Analogue Scales; vs: versus; WEMWS: Warwick‐Edinburgh Mental Well‐being Scale