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

Klein JP, Berger T, Schroeder J, et al. The EVIDENT-trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention. BMC Psychiatry. 2013;13(1): 239.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

The association of childhood trauma and personality disorder with adult 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

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

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

Toxin production in cyanobacterial mats from ponds on the McMurdo Ice Shelf, Antarctica

Cyanobacteria are known to produce hepatotoxic substances, the functional and ecological role of these toxins, however, remains largely unclear. Toxic properties of cyanobacteria collected in Antarctica were investigated to determine whether toxin-producing species can also be found under these environmental conditions. Samples were collected from meltwater ponds on the McMurdo Ice Shelf, Antarctica in the summers of 1997 to 1999. These ponds are colonized by benthic algae and cyanobacterial mats. Oscillatoriales, Nodularia sp., and Nostoc sp. constituted the major taxa in freshwater ponds, while Nostoc sp. was missing from brackish and saline ponds. Samples were taken from either floating, submerged or benthic mats, and extracted for in vitro toxicity testing. The presence of toxins was determined by the phosphatase-inhibition assay and by high performance liquid chromatography. The cytotoxic properties of the extracts were investigated in hepatocytes determining 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl-tetrazolium bromide metabolism and trypan blue dye exclusion. The results show that all cyanobacterial extracts display phosphatase-inhibiting activity, of which approximately half had significantly greater than 50% inhibiting activity. The presence of nodularin and microcystin-LR was established by high performance liquid chromatography. Cytotoxic properties, independent of the phosphatase inhibiting activity, were also detected. Toxic strains of cyanobacteria can therefore also be found in Antarctica and this finding may lead to further insight into potential ecological roles of cyanobacterial phosphatase inhibiting toxins

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)

Attitudes Towards Internet Interventions Among Psychotherapists and Individuals with Mild to Moderate Depression Symptoms

Internet interventions may help bridging gaps in the treatment of depression but dissemination is slow in most countries. Attitudes towards these novel treatments options among health care professionals and potential users may be crucial for a successful implementation. We recruited 1004 adults with mild to moderate depression symptoms within a randomized-controlled trial (RCT) on the efficacy of an Internet intervention (EVIDENT trial), and 428 licensed psychotherapists. We used the Attitudes towards Psychological Online Interventions Questionnaire (APOI) and confirmed psychometric validity of an adapted version for health care professionals, in order to test if psychotherapists hold more negative attitudes towards such interventions compared to individuals with depression symptoms, and to explore variables that predict these attitudes. Individuals with depression symptoms reported more positive attitudes towards Internet interventions than psychotherapists (large group difference; η p 2  = 0.384). Recruitment in clinical settings was associated with more negative attitudes compared to recruitment via the media. Among therapists, endorsing a psychodynamic rather than another theoretical orientation was associated with more pronounced negative attitudes. Results elucidate possible reasons for the slow dissemination of Internet interventions and suggest pathways for appropriate implementation into healthcare services

Selbstmanagement Interventionen in der Behandlung depressiver Störungen: reif für die klinische Praxis?

Nur etwa die Hälfte derjenigen, die an einer depressiven Störung leiden, sucht auch eine Behandlung auf. Selbst- management Interventionen sind eine Möglichkeit, diese Behandlungslücke zu reduzieren. Diese Interventionen basieren meist auf evidenzbasierten Techniken der Kog- nitiven Verhaltenstherapie, welche statt durch einen Therapeuten durch ein Computerprogramm vermittelt werden. Zahlreiche Studien belegen die Wirksamkeit die- ser Interventionen. Diese Studien werfen allerdings auch eine Reihe an Fragen auf. Diese betreffen die Wirksam- keit sowohl im Fremdrating als auch im Langzeitverlauf und die Wirksamkeit bei schwerer depressiver Sympto- matik oder in der Kombination mit antidepressiver Medi- kation. Schließlich stellt sich die Frage nach dem Einsatz dieser Interventionen bei Patienten in der klinischen Praxis und bei Menschen, die nicht besonders internetaf- fin sind. Diese Fragen haben wir im Rahmen einer großen randomisiertenStudie adressiert (EVIDENT-Stu- die). In dieser Studie wurde die Wirksamkeit Interven- tion deprexis® untersucht. Die Ergebnisse dieser Studie werden in dieser Übersicht zusammengefasst und in den Kontext anderer in Deutschland verfügbarer Interventio- nen gestellt

Maintaining Outcomes of Internet-Delivered Cognitive-Behavioral Therapy for Depression: A Network Analysis of Follow-Up Effects

Background: Depression is a highly prevalent mental disorder, but only a fraction of those affected receive evidence-based treatments. Recently, Internet-based interventions were introduced as an efficacious and cost-effective approach. However, even though depression is a heterogenous construct, effects of treatments have mostly been determined using aggregated symptom scores. This carries the risk of concealing important effects and working mechanisms of those treatments. Methods: In this study, we analyze outcome and long-term follow-up data from the EVIDENT study, a large (N = 1,013) randomized-controlled trial comparing an Internet intervention for depression (Deprexis) with care as usual. We use Network Intervention Analysis to examine the symptom-specific effects of the intervention. Using data from intermediary and long-term assessments that have been conducted over 36 months, we intend to reveal how the treatment effects unfold sequentially and are maintained. Results: Item-level analysis showed that scale-level effects can be explained by small item-level effects on most depressive symptoms at all points of assessment. Higher scores on these items at baseline predicted overall symptom reduction throughout the whole assessment period. Network intervention analysis offered insights into potential working mechanisms: while deprexis directly affected certain symptoms of depression (e.g., worthlessness and fatigue) and certain aspects of the quality of life (e.g., overall impairment through emotional problems), other domains were affected indirectly (e.g., depressed mood and concentration as well as activity level). The configuration of direct and indirect effects replicates previous findings from another study examining the same intervention. Conclusions: Internet interventions for depression are not only effective in the short term, but also exert long-term effects. Their effects are likely to affect only a small subset of problems. Patients reporting these problems are likely to benefit more from the intervention. Future studies on online interventions should examine symptom-specific effects as they potentially reveal the potential of treatment tailoring. Clinical Trial Registration: ClinicalTrials.gov, Identifier: NCT02178631