A comparison of the three year course between chronic depression and depression with multiple vs. few prior episodes.

This study tested the hypothesis that chronic depression (CD) is more similar to depression with multiple prior episodes (ME) than to depression with few prior episodes (FE). Data from participants (n = 1013) with mild to moderate depressive symptoms (Patient Health Questionnaire [PHQ-9] score 5 - 14) who took part in a randomized control trial of an internet intervention for depression (EVIDENT trial) were re-analyzed. The MINI-interview was conducted to diagnose CD (n = 376). If CD was not diagnosed, the self-reported number of depressive episodes was used to categorize participants as having episodic depression with up to five (FE, n = 422) or more than five (ME, n = 215) prior episodes. Over a three-year period, participants were assessed repeatedly regarding the course of depression (PHQ-9, QIDS), quality of life (SF-12) and therapeutic progress (FEP-2). At baseline, most scores were different between CD and FE but comparable between CD and ME. Time to remission did not differ between CD and ME but was longer in CD compared to FE. Results suggest that ME closely resembles CD and that CD differs from FE.

Identifying change-dropout patterns during an Internet-based intervention for depression by applying the Muthen-Roy model.

To date, only few studies have attempted to investigate non-ignorable dropout during Internet-based interventions by applying an NMAR model, which includes missing data indicators in its equations. Here, the Muthen-Roy model was used to investigate change and dropout patterns in a sample of patients with mild-to-moderate depression symptoms (N = 483) who were randomized to a 12-week Internet-based intervention (deprexis, identifier: NCT01636752). Participants completed the PHQ-9 biweekly during the treatment. We identified four change-dropout patterns: Participants showing high impairment, improvement and low dropout probability (C3, N = 134) had the highest rate of reliable change at 6- and 12-month follow-up. A further pattern was characterized by high impairment, deterioration and high dropout probability (C2, N = 32), another by low impairment, improvement and high dropout probability (C1, N = 198). The last pattern was characterized by high impairment, no change and low dropout probability (C4, N = 119). In addition to deterioration, also rapid improvement may lead to dropout as a result of a perceived "good enough" dosage of treatment. This knowledge may strengthen sensitivity for the mechanisms of dropout and help to consider its meaning in efforts to optimize treatment selection.

Social phobia moderates the outcome in the EVIDENT study: A randomized controlled trial on an Internet-based psychological intervention for mild to moderate depressive symptoms.

OBJECTIVE: Data from the EVIDENT trial were reanalyzed to examine whether specific anxiety-related comorbidities moderate the effect of an Internet intervention on depression outcome. METHOD: The EVIDENT study is a randomized controlled trial that included N = 1,013 participants with mild to moderate depressive symptoms (i.e., scores between 5 and 14 on the Patient Health Questionnaire-9 [PHQ-9]) who were randomized to a control group with access to care-as-usual (n = 504) or to an intervention group, which accessed the Internet intervention Deprexis adjunctively to care-as-usual (n = 509). Anxiety-related comorbidities (generalized anxiety disorder, social phobia, panic disorder, agoraphobia, panic disorder with agoraphobia, specific phobia, posttraumatic stress disorder, obsessive-compulsive disorder) were assessed with the Web Screening Questionnaire at baseline. Multilevel models were performed. RESULTS: Twelve potential moderators (8 specific anxiety-related comorbidities, depression severity, and 3 previously identified moderators in the EVIDENT trial) were examined within 1 multilevel model, and only social phobia moderated the intervention effect on depression outcome (in favor of Deprexis). This moderating effect of social phobia did not depend on the other moderators' being included in the model. These results emerged for continuous PHQ-9 scores as well as for clinically important PHQ-9 changes as outcome (p < .05). However, moderating effects did not reach small effect sizes, accounted for less than 1% of the variance in change in depressive symptoms, and showed limited reproducibility in randomly selected split halves. CONCLUSIONS: Deprexis appears to be most effective for participants with mild to moderate depressive symptoms and comorbid social phobia, but further replications of this finding are necessary. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Health economic evaluation of a web-based intervention for depression: the EVIDENT-trial, a randomized controlled study.

BACKGROUND: Depression often remains undiagnosed or treated inadequately. Web-based interventions for depression may improve accessibility of treatment and reduce disease-related costs. This study aimed to examine the potential of the web-based cognitive behavioral intervention "deprexis" in reducing disease-related costs. METHODS: Participants with mild to moderate depressive symptoms were recruited and randomized to either a 12-week web-based intervention (deprexis) in addition to care as usual (intervention group) or care as usual (control group). Outcome measures were health-related resource use, use of medication and incapacity to work as well as relating direct health care costs. Outcomes were assessed on patients' self-report at baseline, three months and six months. RESULTS: A total of 1013 participants were randomized. In both groups total direct health care costs decreased during the study period, but changes from baseline did not significantly differ between study groups. Numeric differences between study groups existed in outpatient treatment costs. They could be attributed to differences in changes of costs for psychotherapeutic treatment from baseline. Whereas costs for psychotherapeutic treatment decreased in the intervention group, costs increased in the control group (- 16.8% (€80) vs. + 14.7% (€60)) (tdf = 685 = 2.57; p = 0.008). CONCLUSION: The study indicates the health economic potential of innovative e-mental-health programs. There is evidence to suggest that the use of deprexis over a period of 12 weeks leads to a decrease in outpatient treatment cost, especially in those related to different types of psychotherapeutic treatment.

[Self-management interventions in the treatment of depressive disorders: ready for clinical practice?] / Selbstmanagement Interventionen in der Behandlung depressiver Störungen: reif für die klinische Praxis?

Only about half of those suffering from a depressive disorder seek treatment. Self-management interventions are one way to reduce this treatment gap. These interventions are mostly based on evidence-based techniques of cognitive behavioural therapy, which are taught by a computer program instead of a therapist. Numerous studies have shown the effectiveness of these interventions. However, these studies also raise a number of questions. These concern the efficacy both in the external rating and in the long-term course and the efficacy in severe depressive symptoms or in combination with antidepressant medication. Finally, the question arises as to the use of these interventions in patients in clinical practice and in people who are not particularly Internet-savvy. We addressed these questions in a large randomized study (EVIDENT study). This study investigated the efficacy of Intervention deprexis®. The results of this study are summarised in this overview and placed in the context of other interventions available in Germany.

Bridging the "digital divide": A comparison of use and effectiveness of an online intervention for depression between Baby Boomers and Millennials.

BACKGROUND: Psychological online interventions (POIs) for depression have demonstrated promising effects. However, there are fewer randomized controlled studies on POIs among older adults with depression. The goal of the present study was to compare the use and efficacy of Deprexis, an online intervention for depression, among Millennials (18-35 years) and Baby Boomers (50-65 years). METHODS: We completed a secondary data analysis on a subset (N = 577) of participants in the EVIDENT trial, a parallel-groups, pragmatic, randomized, controlled single-blind study, which compared a 12-week POI (Deprexis) to care as usual (CAU). Outcomes were assessed at baseline, 3 months (post-assessment) and 6 months (follow-up). The main outcome of interest was change on self-rated depression severity (PHQ-9). RESULTS: Compared to Millennials, Boomers used the intervention significantly more often (d = 0.45) and for a longer duration (d = 0.46), and endorsed more positive attitudes towards POIs (d = 0.14). There was no significant Age Group by Intervention Group interaction for change in PHQ-9. The post-assessment between-group effect size (intervention vs. CAU control) for Millennials and Boomers were d = 0.26 and d = 0.39, respectively, and were stable at follow-up (d = 0.37 and d = 0.39). LIMITATIONS: Age-based dichotomization may not accurately represent participants' experiences with and use of technology. CONCLUSIONS: The POI examined in this trial was superior to CAU and was comparably effective among groups of adults defined as Millennials and Baby Boomers. Adults of the Baby Boomer generation who participate in POIs may have more positive attitudes towards POIs compared to their younger counterparts.

Impact and change of attitudes toward Internet interventions within a randomized controlled trial on individuals with depression symptoms.

BACKGROUND: Most individuals with depression do not receive adequate treatment. Internet interventions may help to bridge this gap. Research on attitudes toward Internet interventions might facilitate the dissemination of such interventions by identifying factors that help or hinder uptake and implementation, and by clarifying who is likely to benefit. This study examined whether attitudes toward Internet interventions moderate the effects of a depression-focused Internet intervention, and how attitudes change over the course of treatment among those who do or do not benefit. METHODS: We recruited 1,004 adults with mild-to-moderate depression symptoms and investigated how attitudes toward Internet interventions are associated with the efficacy of the program deprexis, and how attitudes in the intervention group change from pre to post over a 3 months intervention period, compared to a control group (care as usual). This study consists of a subgroup analysis of the randomized controlled EVIDENT trial. RESULTS: Positive initial attitudes toward Internet interventions were associated with greater efficacy (η2p  = .014) independent of usage time, whereas a negative attitude (perceived lack of personal contact) was associated with reduced efficacy (η2p  = .012). Users' attitudes changed during the trial, and both the magnitude and direction of attitude change were associated with the efficacy of the program over time (η2p  = .030). CONCLUSIONS: Internet interventions may be the most beneficial for individuals with positive attitudes toward them. Informing potential users about evidence-based Internet interventions might instill positive attitudes and thereby optimize the benefits such interventions can provide. Assessing attitudes prior to treatment might help identify suitable users.

Differential associations between patterns of child maltreatment and comorbidity in adult depressed patients.

BACKGROUND: Types of maltreatment often co-occur and it is unclear how maltreatment patterns impact on comorbidity in depressed patients. METHODS: We analysed associations of maltreatment patterns with a broad range of comorbidities assessed with diagnostic interviews in 311 treatment-seeking depressed outpatients. RESULTS: Latent class analyses identified a "no maltreatment class" (39%), a "mild to moderate abuse and neglect class" (34%), a "severe abuse and neglect class" (14%) and a "severe neglect class" (13%). We found a dose-response association for the first three classes with comorbid disorders, a general psychopathology factor and an interpersonal insecurity factor. Patients in the "severe abuse and neglect" class had increased odds ratios (OR) of suffering from an anxiety disorder (OR 3.58), PTSD (OR 7.09), Borderline personality disorder (OR 7.97) and suicidality (OR 10.04) compared to those without child maltreatment. Patients in the "severe neglect" class did not have a higher risk for comorbidity than those in the "no maltreatment" class. LIMITATIONS: Class sizes in the "severe abuse and neglect" and the "severe neglect" classes were small and findings should be replicated with other clinical and population samples. CONCLUSIONS: A higher severity rather than the constellation of types of child abuse and neglect was associated with more comorbid disorders. An exception were patients reporting solely severe emotional and physical neglect who had a similar risk for comorbidity as patients without a history of child maltreatment. This may be associated with distinct learning experiences and may inform treatment decisions.

Time to remission from mild to moderate depressive symptoms: One year results from the EVIDENT-study, an RCT of an internet intervention for depression.

BACKGROUND: Internet interventions are effective in treating depressive symptoms but few studies conducted a long-term follow-up. The aim of this study was to test the effectiveness of an internet intervention in increasing the remission rate over a twelve months period. METHODS: A total of 1013 participants with mild to moderate depressive symptoms were randomized to either care as usual alone or a 12-week internet intervention (Deprexis) plus usual care. Self-rated depression severity (PHQ-9) was assessed regularly over twelve months. RESULTS: Remission rates over time were significantly higher in the intervention group (Cox regression: hazard ratio [HR] 1.31; p = 0.009). The intervention was more effective in the subgroup not taking antidepressant medication (Cox regression: HR 1.88; p < 0.001). PHQ-change from baseline was greater in the intervention group (linear mixed model [LMM]: p < 0.001) with the between-group effect gradually decreasing from d = 0.36 at three months to d = 0.13 at twelve months (LMM: group by time interaction: p < 0.001). CONCLUSION: This internet intervention can contribute to achieving remission in people with mild to moderate depressive symptoms, especially if they are not on antidepressant medication (Trial Registration: NCT01636752).

Does recruitment source moderate treatment effectiveness? A subgroup analysis from the EVIDENT study, a randomised controlled trial of an internet intervention for depressive symptoms.

OBJECTIVE: This study aims to examine whether the effects of internet interventions for depression generalise to participants recruited in clinical settings. DESIGN: This study uses subgroup analysis of the results of a randomised, controlled, single-blind trial. SETTING: The study takes place in five diagnostic centres in Germany. PARTICIPANTS: A total of 1013 people with mild to moderate depressive symptoms were recruited from clinical sources as well as internet forums, statutory insurance companies and other sources. INTERVENTIONS: This study uses either care-as-usual alone (control) or a 12-week internet intervention (Deprexis) plus usual care (intervention). MAIN OUTCOME MEASURES: The primary outcome measure was self-rated depression severity (Patient Health Questionnaire-9) at 3 months and 6 months. Further measures ranged from demographic and clinical parameters to a measure of attitudes towards internet interventions (Attitudes towards Psychological Online Interventions Questionnaire). RESULTS: The recruitment source was only associated with very few of the examined demographic and clinical characteristics. Compared with participants recruited from clinical sources, participants recruited through insurance companies were more likely to be employed. Clinically recruited participants were as severely affected as those from other recruitment sources but more sceptical of internet interventions. The effectiveness of the intervention was not differentially associated with recruitment source (treatment by recruitment source interaction=0.28, p=0.84). CONCLUSION: Our results support the hypothesis that the intervention we studied is effective across different recruitment sources including clinical settings. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT01636752.

Defining and Predicting Patterns of Early Response in a Web-Based Intervention for Depression.

BACKGROUND: Web-based interventions for individuals with depressive disorders have been a recent focus of research and may be an effective adjunct to face-to-face psychotherapy or pharmacological treatment. OBJECTIVE: The aim of our study was to examine the early change patterns in Web-based interventions to identify differential effects. METHODS: We applied piecewise growth mixture modeling (PGMM) to identify different latent classes of early change in individuals with mild-to-moderate depression (n=409) who underwent a CBT-based web intervention for depression. RESULTS: Overall, three latent classes were identified (N=409): Two early response classes (n=158, n=185) and one early deterioration class (n=66). Latent classes differed in terms of outcome (P<.001) and adherence (P=.03) in regard to the number of modules (number of modules with a duration of at least 10 minutes) and the number of assessments (P<.001), but not in regard to the overall amount of time using the system. Class membership significantly improved outcome prediction by 24.8% over patient intake characteristics (P<.001) and significantly added to the prediction of adherence (P=.04). CONCLUSIONS: These findings suggest that in Web-based interventions outcome and adherence can be predicted by patterns of early change, which can inform treatment decisions and potentially help optimize the allocation of scarce clinical resources.

Characteristics of participants in a randomized trial of an Internet intervention for depression (EVIDENT) in comparison to a national sample (DEGS1).

BACKGROUND: While the efficacy of Internet interventions for depression has been demonstrated in numerous studies, there is concern that the participants in these studies may systematically differ from depressed subjects in the general population. The goal of this study was to compare participants in a large trial of an Internet intervention for depression with a population-based sample that reported depressive symptomatology in the same range of severity. METHODOLOGY: The analysis is based on a sample of participants of a randomized controlled trial testing the effectiveness of an Internet intervention for depression in mild to moderate depression (EVIDENT, N = 1013) and a subsample of participants in a representative population-based sample (DEGS1, n = 1978). The DEGS1 subsample was chosen based on the score in the Patient Health Questionnaire-9 (PHQ-9, score 5-14) as this was the main inclusion criterion for the EVIDENT study. Both samples were compared with respect to a range of demographic and clinical variables. RESULTS: Compared with the DEGS1 subsample, participants in the EVIDENT sample were significantly more often female (68.6% vs. 56.3%), slightly older (mean age 42.9 vs. 40.4 years), had more often completed highest secondary education (51.3% vs. 22.4%), were clinically more severely affected (moderate depressive symptoms in 62.6% vs. 18.3%) and reported a lower quality of life. CONCLUSION: These findings indicate that participants in this Internet trial were not just internet savvy young males without significant impairment. Future studies should aim to recruit participants with lower educational status to increase the reach of Internet interventions.

The regression discontinuity design showed to be a valid alternative to a randomized controlled trial for estimating treatment effects.

OBJECTIVES: To compare treatment effect estimates obtained from a regression discontinuity (RD) design with results from an actual randomized controlled trial (RCT). STUDY DESIGN AND SETTING: Data from an RCT (EVIDENT), which studied the effect of an Internet intervention on depressive symptoms measured with the Patient Health Questionnaire (PHQ-9), were used to perform an RD analysis, in which treatment allocation was determined by a cutoff value at baseline (PHQ-9 = 10). A linear regression model was fitted to the data, selecting participants above the cutoff who had received the intervention (n = 317) and control participants below the cutoff (n = 187). Outcome was PHQ-9 sum score 12 weeks after baseline. Robustness of the effect estimate was studied; the estimate was compared with the RCT treatment effect. RESULTS: The final regression model showed a regression coefficient of -2.29 [95% confidence interval (CI): -3.72 to -.85] compared with a treatment effect found in the RCT of -1.57 (95% CI: -2.07 to -1.07). CONCLUSION: Although the estimates obtained from two designs are not equal, their confidence intervals overlap, suggesting that an RD design can be a valid alternative for RCTs. This finding is particularly important for situations where an RCT may not be feasible or ethical as is often the case in clinical research settings.

Effects of a Psychological Internet Intervention in the Treatment of Mild to Moderate Depressive Symptoms: Results of the EVIDENT Study, a Randomized Controlled Trial.

BACKGROUND: Mild to moderate depressive symptoms are common but often remain unrecognized and treated inadequately. We hypothesized that an Internet intervention in addition to usual care is superior to care as usual alone (CAU) in the treatment of mild to moderate depressive symptoms in adults. METHODS: This trial was controlled, randomized and assessor-blinded. Participants with mild to moderate depressive symptoms (Patient Health Questionnaire, PHQ-9, score 5-14) were recruited from clinical and non-clinical settings and randomized to either CAU or a 12-week Internet intervention (Deprexis) adjunctive to usual care. Outcomes were assessed at baseline, 3 months (post-assessment) and 6 months (follow-up). The primary outcome measure was self-rated depression severity (PHQ-9). The main analysis was based on the intention-to-treat principle and used linear mixed models. RESULTS: A total of 1,013 participants were randomized. Changes in PHQ-9 from baseline differed signixFB01;cantly between groups (t825 = 6.12, p < 0.001 for the main effect of group). The post-assessment between-group effect size in favour of the intervention was d = 0.39 (95% CI: 0.13-0.64). It was stable at follow-up, with d = 0.32 (95% CI: 0.06-0.69). The rate of participants experiencing at least minimally clinically important PHQ-9 change at the post-assessment was higher in the intervention group (35.6 vs. 20.2%) with a number needed to treat of 7 (95% CI: 5-10). CONCLUSIONS: The Internet intervention examined in this trial was superior to CAU alone in reducing mild to moderate depressive symptoms. The magnitude of the effect is clinically important and has public health implications.

Development and psychometric evaluation of the Interactive Test of Interpersonal Behavior (ITIB): a pilot study examining interpersonal deficits in chronic depression.

Chronic depression is assumed to be caused and maintained by interpersonal deficits. We describe the development and psychometric evaluation of the Interactive Test of Interpersonal Behavior (ITIB) that we developed for self-assessment of these deficits. Participants with chronic depression (CD, N = 15), episodic depression (ED, N = 15) and healthy controls (HC, N = 15) participated in this pilot study. They completed the ITIB and a number of pen and paper questionnaires including the Lübeck Questionnaire of Preoperational Thinking (LQPT) and the inventory of interpersonal problems (IIP). The ITIB was highly acceptable for use in these participants. Internal consistency for the ITIB was adequate for group comparisons (Cronbach's alpha = 0.649). Item-total correlations indicated adequate discriminatory power of five of the six items. The ITIB correlated moderately with the LQPT (r = 0.524) and the IIP (r = -0.568). The ITIB score differed significantly between the diagnostic groups (ANOVA F(2,42) = 6.22, p = 0.004). It was the only measure that - albeit at a trend level - was associated with diagnostic group (CD vs. ED) on multinomial logistic regression analysis (B = 0.049 ± 0.029; OR 1.051; p = 0.088). We found preliminary evidence that the ITIB is an acceptable and psychometrically adequate measure of interpersonal behavior that distinguishes between patients with CD and patients with ED. If replicated with an improved version of the test, our results could support the hypothesis that having interpersonal problems is a core deficit in patients with CD.

Development of a questionnaire measuring Attitudes towards Psychological Online Interventions-the APOI.

BACKGROUND: Only a minority of people suffering from depression receive adequate treatment. Psychological Online Interventions (POIs) could help bridge existing treatment gaps and augment the effectiveness of current treatments. Apart from effectiveness, user acceptance of POIs must be achieved if such interventions are to be broadly implemented in existing health-care. Valid measurement tools examining attitudes towards POIs are lacking. Therefore, we examined the dimensionality of attitudes towards POIs, developed a novel questionnaire, the Attitudes towards Psychological Online Interventions Questionnaire (APOI), and gathered data to examine its reliability. METHODS: We recruited a sample of 1004 adults with mild to moderate depressive symptoms from a range of sources. We constructed a set of 35 items based on literature review as well as expert and patient queries. The initial items were subjected to an exploratory factor analysis (EFA) in a randomly selected subsample. A final set of 16 items was subjected to a confirmatory factor analysis (CFA) to cross-validate the factor structure in a separate subsample. RESULTS: The EFA revealed four dimensions: "Scepticism and Perception of Risks", "Confidence in Effectiveness", "Technologization Threat" and "Anonymity Benefits". The model fit in the CFA was excellent relating to all applied indices (χ(2)=105.816, p=.651; SRMR=.042; RMSEA=.013; CFI=.994) and the APOI total scale showed acceptable to good internal consistency. CONCLUSIONS: Further research with the APOI might facilitate the development and dissemination of POIs and, ultimately, help improve the quality of care for people experiencing depressive symptoms.

The association of childhood trauma and personality disorders with chronic depression: A cross-sectional study in depressed outpatients.

OBJECTIVE: Chronic depression has often been associated with childhood trauma. There may, however, be an interaction between personality pathology, childhood trauma, and chronic depression. This interaction has not yet been studied. METHOD: This retrospective analysis is based on 279 patients contacted for a randomized trial in an outpatient psychotherapy center over a period of 18 months from 2010 to 2012. Current diagnoses of a personality disorder and presence of chronic depression were systematically assessed using the Structured Clinical Interview for DSM-IV. Retrospective reports of childhood trauma were collected using the short form of the Childhood Trauma Questionnaire (CTQ-SF). DSM-IV-defined chronic depression was the primary outcome. The association between chronic depression, childhood trauma, and personality disorders was analyzed using correlations. Variables that had at least a small effect on correlation analysis were entered into a series of logistic regression analyses to determine the predictors of chronic depression and the moderating effect of childhood trauma. RESULTS: The presence of avoidant personality disorder, but no CTQ-SF scale, was associated with the chronicity of depression (odds ratio [OR] = 2.20, P = .015). The emotional abuse subscale of the CTQ-SF did, however, correlate with avoidant personality disorder (OR = 1.15, P = .000). The level of emotional abuse had a moderating effect on the effect of avoidant personality disorder on the presence of chronic depression (OR = 1.08, P = .004). Patients who did not suffer from avoidant personality disorder had a decreased rate of chronic depression if they retrospectively reported more severe levels of emotional abuse (18.9% vs 39.7%, respectively). CONCLUSIONS: The presence of avoidant personality pathology may interact with the effect of childhood trauma in the development of chronic depression. This has to be confirmed in a prospective study. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01226238.

Beyond words: sensory properties of depressive thoughts.

Verbal thoughts (such as negative cognitions) and sensory phenomena (such as visual mental imagery) are usually conceptualised as distinct mental experiences. The present study examined to what extent depressive thoughts are accompanied by sensory experiences and how this is associated with symptom severity, insight of illness and quality of life. A large sample of mildly to moderately depressed patients (N = 356) was recruited from multiple sources and asked about sensory properties of their depressive thoughts in an online study. Diagnostic status and symptom severity were established over a telephone interview with trained raters. Sensory properties of negative thoughts were reported by 56.5% of the sample (i.e., sensation in at least one sensory modality). The highest prevalence was seen for bodily (39.6%) followed by auditory (30.6%) and visual (27.2%) sensations. Patients reporting sensory properties of thoughts showed more severe psychopathological symptoms than those who did not. The degree of perceptuality was marginally associated with quality of life. The findings support the notion that depressive thoughts are not only verbal but commonly accompanied by sensory experiences. The perceptuality of depressive thoughts and the resulting sense of authenticity may contribute to the emotional impact and pervasiveness of such thoughts, making them difficult to dismiss for their holder.

The EVIDENT-trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention.

BACKGROUND: Depressive disorders are among the leading causes of worldwide disability with mild to moderate forms of depression being particularly common. Low-intensity treatments such as online psychological treatments may be an effective way to treat mild to moderate depressive symptoms and prevent the emergence or relapse of major depression. METHODS/DESIGN: This study is a currently recruiting multicentre parallel-groups pragmatic randomized-controlled single-blind trial. A total of 1000 participants with mild to moderate symptoms of depression from various settings including in- and outpatient services will be randomized to an online psychological treatment or care as usual (CAU). We hypothesize that the intervention will be superior to CAU in reducing depressive symptoms assessed with the Personal Health Questionnaire (PHQ-9, primary outcome measure) following the intervention (12 wks) and at follow-up (24 and 48 wks). Further outcome parameters include quality of life, use of health care resources and attitude towards online psychological treatments. DISCUSSION: The study will yield meaningful answers to the question of whether online psychological treatment can contribute to the effective and efficient prevention and treatment of mild to moderate depression on a population level with a low barrier to entry. TRIAL REGISTRATION NUMBER: NCT01636752.