Efficacy of the Digital Self-help Programme Edupression.Com® Evaluated Within a Randomized Controlled Trial in Mild to Moderate Unipolar Depressive Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Therapy response
Study Overview
Brief Summary
The aim of the study is to investigate the efficacy and adherence of the digital self-help programme edupression.com®.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participants are blinded with respect to the study arm and will unlikely determine if they are part of the intervention or active control.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention Arm: Psychoeducation with elements of CBT & mood chart.
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).
Intervention: edupression.com® (Other)
Active control arm: (occupational) interventions and progress 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.
Intervention: Health tips (Other)
Active control arm: (occupational) interventions and progress 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.
Intervention: Surveys (Diagnostic Test)
Active control arm: (occupational) interventions and progress 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.
Intervention: Popular psychological interventions (Other)
Outcomes
Primary Outcomes
Therapy response
Time Frame: 3 months
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.
Secondary Outcomes
- Change of Disease Model(3 months)
- Change of Quality of Life(3 months)
- Change of Depression Literacy(3 months)
Investigators
Lukas Pezawas
Assoc.Prof. Priv.Doz. Dr.
Medical University of Vienna