Efficacy of Edupression.Com® in Depressive Patients

Depressive; Episode, Major Clinical Trial

— eFICASY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04839822
• Other study ID #: 2471/2020
• Status: Completed
• Phase: N/A
• Start date: April 28, 2021
• Est. completion date: July 4, 2023

Study information

• Verified date: August 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 4, 2023
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive; Episode, Major
• Recurrence
• Recurrent Depressive Disorder, Current Episode Mild
• Recurrent Depressive Disorder, Current Episode Moderate

Intervention

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.
• 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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (8)

Andrews G, Basu A, Cuijpers P, Craske MG, McEvoy P, English CL, Newby JM. Computer therapy for the anxiety and depression disorders is effective, acceptable and practical health care: An updated meta-analysis. J Anxiety Disord. 2018 Apr;55:70-78. doi: 10.1016/j.janxdis.2018.01.001. Epub 2018 Feb 1. — View Citation

Ben-Haim MS, Williams P, Howard Z, Mama Y, Eidels A, Algom D. The Emotional Stroop Task: Assessing Cognitive Performance under Exposure to Emotional Content. J Vis Exp. 2016 Jun 29;(112):53720. doi: 10.3791/53720. — View Citation

Cuijpers P, Donker T, Johansson R, Mohr DC, van Straten A, Andersson G. Self-guided psychological treatment for depressive symptoms: a meta-analysis. PLoS One. 2011;6(6):e21274. doi: 10.1371/journal.pone.0021274. Epub 2011 Jun 21. — View Citation

Etkin A, Patenaude B, Song YJ, Usherwood T, Rekshan W, Schatzberg AF, Rush AJ, Williams LM. A cognitive-emotional biomarker for predicting remission with antidepressant medications: a report from the iSPOT-D trial. Neuropsychopharmacology. 2015 May;40(6):1332-42. doi: 10.1038/npp.2014.333. Epub 2014 Dec 30. — View Citation

Huckvale K, Nicholas J, Torous J, Larsen ME. Smartphone apps for the treatment of mental health conditions: status and considerations. Curr Opin Psychol. 2020 Dec;36:65-70. doi: 10.1016/j.copsyc.2020.04.008. Epub 2020 May 4. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. — View Citation

Park C, Zhu J, Ho Chun Man R, Rosenblat JD, Iacobucci M, Gill H, Mansur RB, McIntyre RS. Smartphone applications for the treatment of depressive symptoms: A meta-analysis and qualitative review. Ann Clin Psychiatry. 2020 Feb;32(1):48-68. — View Citation

Schroder J, Sautier L, Kriston L, Berger T, Meyer B, Spath C, Kother U, Nestoriuc Y, Klein JP, Moritz S. Development of a questionnaire measuring Attitudes towards Psychological Online Interventions-the APOI. J Affect Disord. 2015 Nov 15;187:136-41. doi: 10.1016/j.jad.2015.08.044. Epub 2015 Aug 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapy response	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.	3 months
Secondary	Change of Depression Literacy	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).	3 months
Secondary	Change of Quality of Life	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 months
Secondary	Change of Disease Model	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).	3 months