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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04839822
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : July 26, 2022
Sponsor:
Information provided by (Responsible Party):
Lukas Pezawas, Medical University of Vienna

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

Condition or disease Intervention/treatment Phase
Depressive; Episode, Major Recurrent Depressive Disorder, Current Episode Moderate Recurrent Depressive Disorder, Current Episode Mild Other: edupression.com® Other: Health tips Diagnostic Test: Surveys Other: Popular psychological interventions Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
Official Title: Efficacy of the Digital Self-help Programme Edupression.Com® Evaluated Within a Randomized Controlled Trial in Mild to Moderate Unipolar Depressive Patients
Actual Study Start Date : April 28, 2021
Estimated Primary Completion Date : April 14, 2023
Estimated Study Completion Date : April 14, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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).
 Other: edupression.com®

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

Diagnostic Test: Surveys
Quizzes and surveys for course monitoring (including suicidality), but without extensive reports.

Other: Popular psychological interventions
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change of Depression Literacy [ Time Frame: 3 months ]
    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).

  2. Change of Quality of Life [ Time Frame: 3 months ]
    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).

  3. Change of Satisfaction with Life [ Time Frame: 3 months ]
    Change of satisfaction with life from baseline to End of Study (EOS) [Time Frame: 3 months] measured with the Satisfaction with Life scale (SWLS).

  4. Change of Disease Model [ Time Frame: 3 months ]
    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).

  5. Change of Attitudes towards Internet Interventions [ Time Frame: 3 months ]
    Change of attitudes towards internet interventions in four domains from baseline to End of Study (EOS) [Time Frame: 3 months] measured with the Attitudes towards Psychological Online Interventions Questionnaire (APOI).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04839822


Contacts
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Contact: Lukas M Pezawas, MD, Prof. 004314040035470 lukas.pezawas@meduniwien.ac.at
Contact: Gabriele Fischer, MD, Prof. 004314040035470 gabriele.fischer@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Lukas Pezawas, MD       lukas.pezawas@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Study Chair: Markus Dold, MD, Priv.Doz. Medical University of Vienna
Principal Investigator: Lukas M Pezawas, MD, Prof. Medical University of Vienna
Study Chair: Gabriele Fischer, MD, Prof. Medical University of Vienna
Study Chair: Lucie Bartova, MD Medical University of Vienna
More Information
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Publications:

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Responsible Party: Lukas Pezawas, Assoc.Prof. Priv.Doz. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04839822    
Other Study ID Numbers: 2471/2020
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: July 26, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lukas Pezawas, Medical University of Vienna:
Depression
Internet-Based Intervention
Mobile Applications
Additional relevant MeSH terms:
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Disease
Recurrence
Depressive Disorder
Depression
Pathologic Processes
 Disease Attributes
Mood Disorders
Mental Disorders
Behavioral Symptoms