NCT02178631

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
2 countries

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

February 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2014

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

1.2 years

First QC Date

June 25, 2014

Last Update Submit

May 26, 2015

Conditions

Severe Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

  • Patient Health Questionnaire - 9 items (PHQ-9)

    Change from Baseline to post (3mths).

Secondary Outcomes (4)

  • Quick Inventory of Depressive Symptoms - Self-Rreport (QIDS-SR16)

    Baseline, post (3 mths), follow-up (6 mths)

  • Generalized Anxiety Disorder - 7 (GAD-7)

    Baseline, post (3 mths), follow-up (6 mths)

  • Patient Health Questionnaire - 15 items (PHQ-15)

    Baseline, post (3 mths), follow-up (6 mths)

  • Short Form Health Survey - 12 (SF-12)

    Baseline, post (3 mths), follow-up (6 mths)

Study Arms (2)

Deprexis

EXPERIMENTAL

Online self-help

Behavioral: Deprexis

CAU

ACTIVE COMPARATOR

Care as usual

Other: CAU

Interventions

DeprexisBEHAVIORAL

Online self-help

Deprexis
CAUOTHER

Care as usual

CAU

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Lifetime diagnosis of schizophrenia or bipolar disorder (as determined by a telephone diagnostic interview) or current suicidality (as determined in a telephone interview)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Psychiatry and Psychotherapy, University of Hamburg

Hamburg, Germany

Location

Gaia AG

Hamburg, Germany

Location

Department of Psychiatry and Psychotherapy, University of Luebeck

Lübeck, Germany

Location

Department of Clinical Psychology and Psychotherapy, University of Bern

Bern, Switzerland

Location

Related Publications (2)

  • 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

  • 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.

    PMID: 33959044DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

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
Dr. med.

Study Record Dates

First Submitted

June 25, 2014

First Posted

July 1, 2014

Study Start

February 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

CH(1)DE(3)