NCT01636752

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,013

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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

Study Start

First participant enrolled

July 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

2.6 years

First QC Date

July 5, 2012

Last Update Submit

October 9, 2018

Conditions

Mild to Moderate Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

  • Personal Health Questionnaire (PHQ-9)

    12 wks

Secondary Outcomes (3)

  • Hamilton Rating Scale for Depression (HRSD)

    12 wks, 6 mths, 12 mths

  • Quick Inventory of Depressive Symptoms (QIDS)

    12 wks, 6 mths, 12 mths

  • Personal Health Questionnaire (PHQ-9)

    6 mths, 12 mths

Study Arms (2)

Deprexis

EXPERIMENTAL

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

Behavioral: Deprexis

Control

NO INTERVENTION

Interventions

DeprexisBEHAVIORAL

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

Deprexis

Eligibility Criteria

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

You may qualify if:

  • PHQ\>4 and \<15

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Charité Berlin

Berlin, Germany

Location

Universität Bielefeld

Bielefeld, Germany

Location

Universität Hamburg

Hamburg, Germany

Location

Universität Lübeck

Lübeck, Germany

Location

Related Publications (8)

  • 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.

    PMID: 24074299BACKGROUND

  • 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.

    PMID: 27230863RESULT

  • 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.

    PMID: 33500282DERIVED

  • 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.

    PMID: 31682137DERIVED

  • 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.

    PMID: 30721109DERIVED

  • 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.

    PMID: 29489038DERIVED

  • 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.

    PMID: 28797829DERIVED

  • 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.

    PMID: 28710212DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinating Investigator

Study Record Dates

First Submitted

July 5, 2012

First Posted

July 10, 2012

Study Start

July 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2017

Last Updated

October 12, 2018

Record last verified: 2018-10

Locations

DE(4)