Efficacy of Edupression.Com® in Depressive Patients (eFICASY)

Efficacy of the Digital Self-help Programme Edupression.Com® Evaluated Within a Randomized Controlled Trial in Mild to Moderate Unipolar Depressive Patients

The aim of the study is to investigate the efficacy and adherence of the digital self-help programme edupression.com®.

The edupression.com® self-help app is an evidence-based low-level psychosocial intervention, which a can be used as as monotherapy as first-line treatment in mild to moderate depressive patients or as complimentary treatment independent of previous therapy response or depression severity. The two foundations of edupression.com® are evidence-based psychoeducation with CBT elements, as well as self-monitoring in the mood chart. Evidence for the efficacy of this approach stems from a large body of literature regarding eHealth (healthcare services provided electronically via the internet) applications in depression. This study's aim is to investigate edupression.com®'s capability to improve the illness course directly by reducing depressive symptoms (primary objective) and indirectly by fostering positive health care effects (secondary objective). The reduction of relapse risk and other preventive effects expected from other studies are beyond the time frame of this study. Beyond the evaluation of edupression.com®, this study could elucidate the general role of psychoeducation and mood tracking in online mental health to improve depression symptoms and adherence. Objectives: The primary objective is to test the clinical efficacy (at least 50% symptom reduction over a 3-month period) of edupression.com® in mild to moderate unipolar depressed patients. The secondary objective is to demonstrate positive health care effects within this 3-month trial period such as psychoeducation, quality of life, patient empowerment and other factors. Study Design: The study design of this clinical trial is consistent with a monocentric, prospective, longitudinal, randomized controlled clinical trial. Patients, currently diagnosed with a mild to moderate major depressive episode (MDE) will be invited to use the digital self-help programme. Following the inclusion procedure, patients will be randomly assigned in a 1:1 ratio to two different treatment arms (A vs. B). Participants of the intervention arm will get full access to the edupression.com® website, while participants of the control arm will get access to a control version of edupression.com® limited to medically useful tips, that have not been shown to be effective in improving depressive symptoms in randomized controlled trials (RCTs).

Depressive; Episode, Major, Recurrent Depressive Disorder, Current Episode Moderate, Recurrent Depressive Disorder, Current Episode Mild

Participants are blinded with respect to the study arm and will unlikely determine if they are part of the intervention or active control.

Patients will receive full access to edupression.com® immediately after inclusion. This intervention includes all medical mechanisms of action of edupression.com®: Psychoeducation with elements of CBT (learning content and exercises) and a mood chart (depression symptom monitoring).

These patients will also receive an edupression.com® account with different content. This content will be limited to medically useful tips, that have have not been shown to be effective in improving depressive symptoms in RCTs. Patients of both arms will be instructed to use chat functions to contact study personnel and to fill out questionnaires and tests to collect outcome and additional measures.

Edupression.com® is an evidence-based self-help program that was developed for the treatment of mild to moderate unipolar depression. It is based on two core foundations, psychoeducation with elements of cognitive behavior therapy (CBT) and a mood chart. Both foundations are registered as a medical product. As such, detailed risk management documentation includes probability and severity of adverse events. Moreover, detailed strategies such as warnings were implemented in the software and documented accordingly. It can be used on a PC as well as on mobile devices (browser, App) at any time.

Interventions that do not directly target depression: general health tips (diet, lifestyle, smoking, etc.), occupational health interventions (back pain prevention, breaks,...), etc.

Popular psychological interventions, which have not been shown to be effective in studies: Affirmation phrases, motivational sayings and quotes (known also from calendars), tests (e.g., Rorschach interpretation), exercises (emotion recognition of faces), multimedia content (pleasant music, landscape images, interviews of famous people with depression), etc.

Depression severity change from baseline to end of study (EOS) [Time Frame: 3 months], compared between treatment vs. control arm measured with the Patient Health Questionnaire. Patient Health Questionnaire scores range from 0 to 27, with a higher score being associated with a higher level of depression.

Depression Literacy change from baseline to end of study (EOS) [Time Frame: 3 months], compared between treatment vs. control arm measured with the Depression Literacy scale (D-Lit).

Change of quality of life in four domains from baseline to End of Study (EOS) [Time Frame: 3 months] measured with the World Health Organization quality of life scale (WHOQOL-BREF).

Change of disease model from baseline to End of Study (EOS) [Time Frame: 3 months] measured with the brief version of the illness perception questionnaire (B-IPQ).

Inclusion Criteria: Male/female Age 18-65 years ICD-10 diagnosis F32.0 & F32.1, depressive episode mild & moderate & F33.0 & F33.1, Recurrent depressive disorder mild & moderate (M.I.N.I.) PHQ-9 (Patient Health Questionnaire-9) score ≥5 ability to be managed as outpatients adherence to the study protocol incl. willingness and minimal experience to understand instructions for edupression.com® Exclusion Criteria: previous or concurrent major medical or neurological illness any history of non-response to either psychotherapy/eHealth interventions (min. 3 month) or medication (min. 6 weeks, adequate antidepressive drug dosing) or any kind of therapy resistance participants in the active phase of other interventional studies ICD-10 diagnosis of substance dependence within the past year, except for caffeine or nicotine or current substance abuse ICD-10 diagnosis of schizophrenia, schizoaffective disorder, bipolar affective disorder, persistent mood disorders, or an anxiety disorder being acutely suicidal either indicated by a score ≥3 on item 9 (suicidal thoughts) on the PHQ-9 or according to the investigator´s opinion failures to comply with the study protocol or to follow the instructions of the investigating team

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