NCT04839822

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

April 28, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2023

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

April 7, 2021

Last Update Submit

August 1, 2023

Conditions

Depressive; Episode, MajorRecurrent Depressive Disorder, Current Episode ModerateRecurrent Depressive Disorder, Current Episode Mild

Keywords

DepressionInternet-Based InterventionMobile Applications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change of Depression Literacy

    3 months

  • Change of Quality of Life

    3 months

  • Change of Disease Model

    3 months

Study Arms (2)

Intervention Arm: Psychoeducation with elements of CBT & mood chart.

EXPERIMENTAL

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®

Active control arm: (occupational) interventions and progress monitoring.

ACTIVE COMPARATOR

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 tipsDiagnostic Test: SurveysOther: Popular psychological interventions

Interventions

edupression.com®OTHER

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.

Intervention Arm: Psychoeducation with elements of CBT & mood chart.
Health tipsOTHER

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

Active control arm: (occupational) interventions and progress monitoring.
SurveysDIAGNOSTIC_TEST

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

Active control arm: (occupational) interventions and progress monitoring.
Popular psychological interventionsOTHER

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.

Active control arm: (occupational) interventions and progress monitoring.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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®

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (8)

  • 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.

    PMID: 32553848BACKGROUND

  • 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.

    PMID: 31675391BACKGROUND

  • 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.

    PMID: 29422409BACKGROUND

  • 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.

    PMID: 21712998BACKGROUND

  • 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.

    PMID: 11556941BACKGROUND

  • 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.

    PMID: 25547711BACKGROUND

  • 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.

    PMID: 27405091BACKGROUND

  • 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.

    PMID: 26331687BACKGROUND

MeSH Terms

Conditions

Depressive DisorderDepression

Interventions

Fertility

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Markus Dold, MD, Priv.Doz.

    Medical University of Vienna

    STUDY CHAIR

  • Lukas M Pezawas, MD, Prof.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

  • Gabriele Fischer, MD, Prof.

    Medical University of Vienna

    STUDY CHAIR

  • Lucie Bartova, MD

    Medical University of Vienna

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are blinded with respect to the study arm and will unlikely determine if they are part of the intervention or active control.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof. Priv.Doz. Dr.

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 9, 2021

Study Start

April 28, 2021

Primary Completion

April 11, 2023

Study Completion

July 4, 2023

Last Updated

August 3, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)