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 “Participants were randomly allocated to a treatment condition comprising 6 weeks of therapist assisted web-based CBT, or to a 6 weeks delayed treatment condition. The intervention included the Norwegian version of the MoodGYM program, brief face-to-face support from a psychologist, and reminder e-mails.” 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT "The intervention included the Norwegian version of the MoodGYM program, brief face-to-face support from a psychologist, and reminder e-mails." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT "Participants were recruited from primary care." "The intervention included the Norwegian version of the MoodGYM program, brief face-to-face support from a psychologist, and reminder e-mails.""“The primary outcome measure was depression symptoms measured with the Beck Depression Inventory-II (BDI-II). Secondary outcome measures included the Beck Anxiety Inventory (BAI), the Hospital Anxiety and Depression Scale (HADS), the Satisfaction with Life Scale (SWLS) and the EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D). All outcomes were measured at baseline and posttreatment/ post-waiting and were based on self-report.” Elaboration from the main body of the manuscript: “The therapists were not blind to the participants` condition. However, steps were taken to blind the evaluation of outcomes by ensuring that post-tests were performed by a research assistant unaware of the participants’ allocation assignment.” 1b-iv) RESULTS section in abstract must contain use data “Post-intervention measures were completed by 37 (71 %) and 47 (87 %) of the 52 participants in the intervention and 54 participants in the delayed treatment group, respectively.” “Mixed-models analyses revealed significant time by condition interactions for the primary outcome measure, BDI-II, (P = .002), for HADS depression and anxiety subscales (P < .001 and P = .003, respectively), and for the SWLS (P = .001). No differential group effects were found for the BAI and the EQ-5D. In comparison to the control group, significantly more participants in the intervention group experienced clinically significant recovery from depression as measured by the BDI-II. Sixty per cent (31 of 52 participants) adhered to the treatment program, and overall treatment satisfaction was high.” 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials “The intervention combining MoodGYM and brief therapist support can be an effective treatment for depression in a sample of primary care patients. The intervention alleviates depressive symptoms and has significant positive effects on anxiety symptoms and satisfaction with life. Moderate rates of non-adherence and predominately positive evaluations of the treatment, also indicates the acceptability of the intervention. The intervention could have a potential for use in a stepped-care approach, but remains to be tested in regular primary health care.” INTRODUCTION 2a-i) Problem and the type of system/solution “The majority of patients with psychological problems will receive most or all of their mental health care in primary care, and findings suggest that many patients prefer to consult their GP for treatment of depression [2, 37-39]. Clinical practice guidelines primarily recommend treating mild to moderate depression using psychosocial interventions [40, 41], and this is also in accordance with reported patient preferences [42-44]. Despite this, structured psychological interventions are infrequently delivered in general practice [45-47], due to time constraints in general practice [48-50] and a lack of knowledge and competence among GPs in the delivery of evidence-based psychological interventions [50, 51]. The use of CBT-based self-help resources could be a way to improve the delivery of psychological interventions in general practice.” 2a-ii) Scientific background, rationale: What is known about the (type of) system “A substantive body of research shows that internet-based CBT can be an efficacious treatment for depression [e.g.11, 12-14].” “An increasing amount of research has pointed to the importance of support in internet-based interventions [25-27].” “Studies have demonstrated the effectiveness of MoodGYM in reducing symptoms of depression and anxiety [19, 23, 24, 28, 32-34]..” “However, few previous trials have investigated the effect of MoodGYM combined with therapist support.” “The use of CBT-based self-help resources could be a way to improve the delivery of psychological interventions in general practice. “ “The current study was designed to trial a procedure for depression treatment prior to its evaluation in general practice.” For this first evaluation of the present intervention a delayed treatment control condition was considered an acceptable comparator. The results of this comparison will give preliminary evidence of the effect of the intervention for this patient group. Further studies will be needed to evaluate the effect compared to other treatments. METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio “The aim was to evaluate the effectiveness and acceptability of a guided self-help intervention combining the MoodGYM program with brief face-to-face therapist support in a sample of primary care patients with mild to moderate symptoms of depression. The primary hypothesis was that therapist supported web-based CBT would lead to a larger reduction in depressive symptoms than the control condition.” 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons “During the first months of the study the protocol was changed by extending the inclusion criterion on BDI-II (from including participants with scores between 14 and 29) to include participants with scores between 10 and 40. This change was due to insufficient recruitment and to the clinical appraisal that patients with scores above 30 could possibly benefit from the treatment, based on their daily functioning and motivation. In addition, their depression was too mild to assure them other public treatment options. Furthermore, several patients with a BDI-II score below 14 reported a need for treatment.” 3b-i) Bug fixes, Downtimes, Content Changes There were no such changes influencing the intervention or the design during the trial.