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Mild to Moderate Depressive SymptomsEVIDENTNCT01636752

Effectiveness of Internet-based Depression Treatment

A study testing Deprexis in people with Mild to Moderate Depressive Symptoms, run by University of Luebeck at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Care for people suffering from depressive symptoms should be given in a step-wise approach. One first step can be the provision of self-help material. Online self-help is an innovative way of providing self-help. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Mild to Moderate Depressive Symptoms
What is being tested?
Deprexis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,013 participants
Where
4 sitesGermany
Study dates
Jul 2012to Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • PHQ>4 and <15

Who cannot join

  • acute suicidality
  • psychotic d/o, bipolar d/o or other severe psychiatric d/o

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Charité Berlin

    Berlin

  • Universität Bielefeld

    Bielefeld

  • Universität Hamburg

    Hamburg

  • Universität Lübeck

    Lübeck

Other trials in Germany

About this study

Care for people suffering from depressive symptoms should be given in a step-wise approach. One first step can be the provision of self-help material. Online self-help is an innovative way of providing self-help. The investigators want to study the effect of an interactive online self-help-program (Deprexis) in the treatment of mild to moderate depressive symptoms. Participants will be randomised to either twelve weeks of online-self help or a waiting-list control. Symptoms of depression and other aspects will be assessed over a one year period. Thereafter the controls will also receive online-self help. The investigators hypothesise that online self-help is superior to the control condition in alleviating depressive symptoms and preventing full blown depression.

Read the detailed description

This study is supported by the German Ministry of Health (BMG) and is a collaborative project of Universität Bern (PD Dr. Thomas Berger), Charité Berlin (PD Dr. Matthias Rose), Universität Bielefeld (Prof. Dr. Wolfgang Greiner), Universität Hamburg (Prof. Dr. Steffen Moritz, Prof. Dr. Bernd Löwe), GAIA AG Hamburg (Dr. Björn Meyer), Universität Tübingen (Prof. Dr. Martin Hautzinger) and Universität Trier (Prof. Dr. Wolfgang Lutz).

Being tested
Deprexis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DeprexisBehavioural

    Online self-help with and without e-mail-support

Study groups in NCT01636752
Study groupRoleWhat they receive
DeprexisExperimentalOnline self-help with and without e-mail-support
Receives: Behavioral: Deprexis
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Personal Health Questionnaire (PHQ-9)

    Measured: 12 wks

Secondary outcomes (3)

  1. Hamilton Rating Scale for Depression (HRSD)

    Measured: 12 wks, 6 mths, 12 mths

  2. Quick Inventory of Depressive Symptoms (QIDS)

    Measured: 12 wks, 6 mths, 12 mths

  3. Personal Health Questionnaire (PHQ-9)

    Measured: 6 mths, 12 mths

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionFeb 2015
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,013 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01636752
Sponsor's protocol ID
EVIDENT Trial
Acronym
EVIDENT
Status last verified
Oct 2018
First submitted
5 Jul 2012
Last updated
12 Oct 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Klein JP, Berger T, Schroder J, Spath C, Meyer B, Caspar F, Lutz W, Greiner W, Hautzinger M, Rose M, Grafe V, Hohagen F, Andersson G, Vettorazzi E, Moritz S. The EVIDENT-trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention. BMC Psychiatry. 2013 Sep 28;13:239. doi: 10.1186/1471-244X-13-239.

    PubMed 24074299

  • Klein JP, Berger T, Schroder J, Spath C, Meyer B, Caspar F, Lutz W, Arndt A, Greiner W, Grafe V, Hautzinger M, Fuhr K, Rose M, Nolte S, Lowe B, Anderssoni G, Vettorazzi E, Moritz S, Hohagen F. Effects of a Psychological Internet Intervention in the Treatment of Mild to Moderate Depressive Symptoms: Results of the EVIDENT Study, a Randomized Controlled Trial. Psychother Psychosom. 2016;85(4):218-28. doi: 10.1159/000445355. Epub 2016 May 27.

    PubMed 27230863

  • Nolte S, Busija L, Berger T, Meyer B, Moritz S, Rose M, Schroder J, Spath-Nellissen C, Klein JP. Do sociodemographic variables moderate effects of an internet intervention for mild to moderate depressive symptoms? An exploratory analysis of a randomised controlled trial (EVIDENT) including 1013 participants. BMJ Open. 2021 Jan 26;11(1):e041389. doi: 10.1136/bmjopen-2020-041389.

    PubMed 33500282

  • Probst T, Berger T, Meyer B, Spath C, Schroder J, Hohagen F, Moritz S, Klein JP. Social phobia moderates the outcome in the EVIDENT study: A randomized controlled trial on an Internet-based psychological intervention for mild to moderate depressive symptoms. J Consult Clin Psychol. 2020 Jan;88(1):82-89. doi: 10.1037/ccp0000441. Epub 2019 Nov 4.

    PubMed 31682137

  • Arndt A, Lutz W, Rubel J, Berger T, Meyer B, Schroder J, Spath C, Hautzinger M, Fuhr K, Rose M, Hohagen F, Klein JP, Moritz S. Identifying change-dropout patterns during an Internet-based intervention for depression by applying the Muthen-Roy model. Cogn Behav Ther. 2020 Jan;49(1):22-40. doi: 10.1080/16506073.2018.1556331. Epub 2019 Feb 5.

    PubMed 30721109

  • Schroder J, Berger T, Meyer B, Lutz W, Spath C, Michel P, Rose M, Hautzinger M, Hohagen F, Klein JP, Moritz S. Impact and change of attitudes toward Internet interventions within a randomized controlled trial on individuals with depression symptoms. Depress Anxiety. 2018 May;35(5):421-430. doi: 10.1002/da.22727. Epub 2018 Feb 28.

    PubMed 29489038

  • Klein JP, Spath C, Schroder J, Meyer B, Greiner W, Hautzinger M, Lutz W, Rose M, Vettorazzi E, Andersson G, Hohagen F, Moritz S, Berger T. Time to remission from mild to moderate depressive symptoms: One year results from the EVIDENT-study, an RCT of an internet intervention for depression. Behav Res Ther. 2017 Oct;97:154-162. doi: 10.1016/j.brat.2017.07.013. Epub 2017 Jul 21.

    PubMed 28797829

  • Klein JP, Gamon C, Spath C, Berger T, Meyer B, Hohagen F, Hautzinger M, Lutz W, Vettorazzi E, Moritz S, Schroder J. Does recruitment source moderate treatment effectiveness? A subgroup analysis from the EVIDENT study, a randomised controlled trial of an internet intervention for depressive symptoms. BMJ Open. 2017 Jul 13;7(7):e015391. doi: 10.1136/bmjopen-2016-015391.

    PubMed 28710212

Questions about this trial

What is this clinical trial studying?

A study testing Deprexis in people with Mild to Moderate Depressive Symptoms, run by University of Luebeck at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Personal Health Questionnaire (PHQ-9) (time frame: 12 wks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01636752, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.

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