Effectiveness of Internet-based Depression Treatment (EVIDENT) in Severe Depression

NCT ID: NCT02178631

Last Updated: 2015-05-27

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

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-05-31

Brief Summary

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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 severe 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 six months period. 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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Conditions

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Severe 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

Group Type EXPERIMENTAL

Deprexis

Intervention Type BEHAVIORAL

Online self-help

CAU

Care as usual

Group Type ACTIVE_COMPARATOR

CAU

Intervention Type OTHER

Care as usual

Interventions

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Deprexis

Online self-help

Intervention Type BEHAVIORAL

CAU

Care as usual

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 65, ability to read German, willingness to participate in a telephone diagnostic interview, achieving a score of at least 15 on the PHQ-9 in an initial screening, and providing written informed consent

Exclusion Criteria

* Lifetime diagnosis of schizophrenia or bipolar disorder (as determined by a telephone diagnostic interview) or current suicidality (as determined in a telephone interview)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Björn Meyer, Gaia AG, Hamburg, Germany / Department of Psychology, City University, London, United Kingdom

UNKNOWN

Sponsor Role collaborator

University of Hamburg-Eppendorf

OTHER

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role collaborator

University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Philipp Klein

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Psychiatry and Psychotherapy, University of Hamburg

Hamburg, , Germany

Site Status

Gaia AG

Hamburg, , Germany

Site Status

Department of Psychiatry and Psychotherapy, University of Luebeck

Lübeck, , Germany

Site Status

Department of Clinical Psychology and Psychotherapy, University of Bern

Bern, , Switzerland

Site Status

Countries

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Germany Switzerland

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)

Kaiser T, Boschloo L, Berger T, Meyer B, Spath-Nellissen C, Schroder J, Hohagen F, Moritz S, Klein JP. Maintaining Outcomes of Internet-Delivered Cognitive-Behavioral Therapy for Depression: A Network Analysis of Follow-Up Effects. Front Psychiatry. 2021 Apr 20;12:598317. doi: 10.3389/fpsyt.2021.598317. eCollection 2021.

Reference Type DERIVED
PMID: 33959044 (View on PubMed)

Other Identifiers

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EVIDENTplus

Identifier Type: -

Identifier Source: org_study_id

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