CONSORT-EHEALTH Checklist V1.6.2 Report

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT The abstract includes these phrases: "a novel, self-guided internet-based intervention (called Trauma TIPS) based on techniques from cognitive behavioral therapy (CBT)" "internet intervention (n=151) or to no early intervention (n=149)" "Trauma TIPS consisted of psychoeducation, in vivo exposure and stress management techniques" 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Abstract includes phrase: "randomly assigned to receive the fully automated Trauma TIPS internet intervention (n=151)" 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT "PTSD symptom severity was assessed at 1, 3, 6 and 12 months post-injury using the Clinician Administered PTSD Scale by blinded trained interviewers and self-report instrument (Impact of Events Scale-Revised). Secondary outcomes were acute anxiety and arousal (assessed online), selfreported depressive and anxiety symptoms and mental health care utilization. " 1b-iv) RESULTS section in abstract must contain use data "Results. The mean number of intervention logins was 1.7 (SD=2.5, Mdn=1, IQR=1-2). Thirty-four patients did not log in (22.5%), 63 (41.7%) logged in once and 54 (35.8%) logged in multiple times (M=3.6, SD=3.5, Mdn=3, IQR=2-4). On clinician assessed and self-reported PTSD symptoms, both the intervention and control group showed a significant decrease over time (P<.001) without significant differences in trend. PTSD at 12 months was diagnosed in 4.7% of controls and 4.4% of intervention group patients. There were no group differences on anxiety or depressive symptoms over time. " 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials "Conclusions. Our results do not support the efficacy of the Trauma TIPS internet-based early intervention in the prevention of PTSD symptoms for an unselected population of injury patients. Future research should point out the efficacy of applying interventions to selected individuals and should focus on increasing intervention usage. "includes phrase: "randomly assigned to receive the fully automated Trauma TIPS internet intervention (n=151)" 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT "PTSD symptom severity was assessed at 1, 3, 6 and 12 months post-injury using the Clinician Administered PTSD Scale by blinded trained interviewers and self-report instrument (Impact of Events Scale-Revised). Secondary outcomes were acute anxiety and arousal (assessed online), selfreported depressive and anxiety symptoms and mental health care utilization. " 1b-iv) RESULTS section in abstract must contain use data "Results. The mean number of intervention logins was 1.7 (SD=2.5, Mdn=1, IQR=1-2). Thirty-four patients did not log in (22.5%), 63 (41.7%) logged in once and 54 (35.8%) logged in multiple times (M=3.6, SD=3.5, Mdn=3, IQR=2-4). On clinician assessed and self-reported PTSD symptoms, both the intervention and control group showed a significant decrease over time (P<.001) without significant differences in trend. PTSD at 12 months was diagnosed in 4.7% of controls and 4.4% of intervention group patients. There were no group differences on anxiety or depressive symptoms over time. " 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials "Conclusions. Our results do not support the efficacy of the Trauma TIPS internet-based early intervention in the prevention of PTSD symptoms for an unselected population of injury patients. Future research should point out the efficacy of applying interventions to selected individuals and should focus on increasing intervention usage. " INTRODUCTION 2a-i) Problem and the type of system/solution "Until now, efforts to prevent PTSD onset, e.g. psychological debriefing, have been unsuccessful [7,8]. [. ]. It is yet unclear whether CBT-techniques administered as a single session early intervention are efficacious in preventing PTSD. We developed Trauma TIPS, a brief self-guided internet intervention based on established CBT-techniques. " 2a-ii) Scientific background, rationale: What is known about the (type of) system "Although both self-guided and therapist-assisted internet-based CBT programs have been successful in the treatment of PTSD [16], there is a great lack of studies that tested whether these programs may prevent PTSD. Our study examined whether Trauma TIPS prevents the onset of PTSD symptoms in injury patients compared to care as usual. In addition, we evaluated whether Trauma TIPS prevented symptoms of depression and anxiety and led to a decrease in mental health care utilization during the first year after injury. " METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio "Trauma TIPS aims to decrease acute levels of distress, anxiety and arousal, known to predict PTSD [13], and to prevent the onset of PTSD symptoms by providing information on successful coping, instructions for self-exposure to fearful situations and stress management techniques. [. ] Our study examined whether Trauma TIPS prevents the onset of PTSD symptoms in injury patients compared to care as usual. In addition, we evaluated whether Trauma TIPS prevented symptoms of depression and anxiety and led to a decrease in mental health care utilization during the first year after injury. " 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons NA 3b-i) Bug fixes, Downtimes, Content Changes NA, no major changes made during trial. 4a) CONSORT: Eligibility criteria for participants "Injury patients transported to the level-1 trauma centers of the Academic Medical Center (AMC) and VU University Medical Center (VUmc) Amsterdam, The Netherlands, were eligible for inclusion. Inclusion criteria were: having experienced a traumatic event (cf. Criterion A1 DSM-IV PTSD diagnosis) [6]; age 18 years or older; and proficiency in Dutch. Exclusion criteria were: the injury resulted from deliberate self-harm; organic brain condition, psychotic disorder, bipolar disorder or depression with psychotic features (cf. DSM-IV) [6]; moderate to severe traumatic brain injury (TBI) (according to a Glasgow Coma Score (GCS) [18] less than 13); and permanent residency outside the Netherlands. " 4a-i) Computer / Internet literacy "Research assistants visited patients with a laptop in case of hospitalization or a lack of internet or computer access. " 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: "Patients were contacted in-hospital or via telephone within 72 hours post-injury to assess eligibility and to schedule a baseline assessment. [. ] The assessments took place at the AMC’s Center for Anxiety Disorders, at bedside in the hospital or at the private home of the patient. " 4a-iii) Information giving during recruitment Patients were informed about the specifics of the study face-to-face, since every assessment was performed during a clinical interview. Interviewers discussed what was expected from the participants in both conditions (in terms of intervention versus no intervention) and what the assesments entailed. 4b) CONSORT: Settings and locations where the data were collected "The assessments took place at the AMC’s Center for Anxiety Disorders, at bedside in the hospital or at the private home of the patient. "