Effectiveness of Internet-based Depression Treatment

NCT ID: NCT01636752

Last Updated: 2018-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1013 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Mild to Moderate Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Deprexis

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

Group Type EXPERIMENTAL

Deprexis

Intervention Type BEHAVIORAL

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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Deprexis

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* PHQ\>4 and \<15

Exclusion Criteria

* acute suicidality
* psychotic d/o, bipolar d/o or other severe psychiatric d/o
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Philipp Klein

Coordinating Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Charité Berlin

Berlin, , Germany

Site Status

Universität Bielefeld

Bielefeld, , Germany

Site Status

Universität Hamburg

Hamburg, , Germany

Site Status

Universität Lübeck

Lübeck, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 24074299 (View on PubMed)

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.

Reference Type RESULT
PMID: 27230863 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33500282 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31682137 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30721109 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29489038 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28797829 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28710212 (View on PubMed)

Other Identifiers

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EVIDENT Trial

Identifier Type: -

Identifier Source: org_study_id

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