Severe Depressive SymptomsNCT02178631
Effectiveness of Internet-based Depression Treatment (EVIDENT) in Severe Depression
A study testing Deprexis and CAU in people with Severe Depressive Symptoms, run by University of Luebeck at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Depressive Symptoms
- What is being tested?
- Deprexis and CAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Feb 2013to May 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lifetime diagnosis of schizophrenia or bipolar disorder (as determined by a telephone diagnostic interview) or current suicidality (as determined in a telephone interview)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Department of Psychiatry and Psychotherapy, University of Hamburg
Hamburg
Gaia AG
Hamburg
Department of Psychiatry and Psychotherapy, University of Luebeck
Lübeck
Switzerland1 site
Department of Clinical Psychology and Psychotherapy, University of Bern
Bern
About this study
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.
- Conditions
- Severe Depressive Symptoms
- Being tested
- Deprexis, CAU
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeprexisBehavioural
Online self-help
CAUOther
Care as usual
| Study group | Role | What they receive |
|---|---|---|
| Deprexis | Experimental | Online self-help Receives: Behavioral: Deprexis |
| CAU | Active comparator | Care as usual Receives: Other: CAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire - 9 items (PHQ-9)
Measured: Change from Baseline to post (3mths).
Secondary outcomes (4)
Quick Inventory of Depressive Symptoms - Self-Rreport (QIDS-SR16)
Measured: Baseline, post (3 mths), follow-up (6 mths)
Generalized Anxiety Disorder - 7 (GAD-7)
Measured: Baseline, post (3 mths), follow-up (6 mths)
Patient Health Questionnaire - 15 items (PHQ-15)
Measured: Baseline, post (3 mths), follow-up (6 mths)
Short Form Health Survey - 12 (SF-12)
Measured: Baseline, post (3 mths), follow-up (6 mths)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startFeb 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Collaborators
- Björn Meyer, Gaia AG, Hamburg, Germany / Department of Psychology, City University, London, United Kingdom, University of Hamburg-Eppendorf, University of Bern
- Responsible party
- Principal investigator, Philipp Klein, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178631
- Sponsor's protocol ID
- EVIDENTplus
- Status last verified
- May 2015
- First submitted
- 25 Jun 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
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 24074299Kaiser 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.
PubMed 33959044
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Internet-based Depression Treatment (EVIDENT) in Severe Depression
- ClinicalTrials.gov ID
- NCT02178631
- Acronym / sponsor ID
- EVIDENTplus
- Conditions
- Severe Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Collaborators
- Björn Meyer, Gaia AG, Hamburg, Germany / Department of Psychology, City University, London, United Kingdom, University of Hamburg-Eppendorf, University of Bern
- Study start
- Feb 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deprexis | Experimental | Behavioral: DeprexisOnline self-help |
| CAU | Active comparator | Other: CAUCare as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Lifetime diagnosis of schizophrenia or bipolar disorder (as determined by a telephone diagnostic interview) or current suicidality (as determined in a telephone interview)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeprexisOnline self-help | Behavioural | Deprexis |
| CAUCare as usual | Other | CAU |
Primary outcome
Patient Health Questionnaire - 9 items (PHQ-9)
Time frame: Change from Baseline to post (3mths).
4 secondary outcomes
Quick Inventory of Depressive Symptoms - Self-Rreport (QIDS-SR16)
Time frame: Baseline, post (3 mths), follow-up (6 mths)
Generalized Anxiety Disorder - 7 (GAD-7)
Time frame: Baseline, post (3 mths), follow-up (6 mths)
Patient Health Questionnaire - 15 items (PHQ-15)
Time frame: Baseline, post (3 mths), follow-up (6 mths)
Short Form Health Survey - 12 (SF-12)
Time frame: Baseline, post (3 mths), follow-up (6 mths)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Background: PubMed 24074299Klein 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.
- Derived from this study: PubMed 33959044Kaiser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deprexis and CAU in people with Severe Depressive Symptoms, run by University of Luebeck at 4 sites in 2 countries.
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 1 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 27 May 2015. 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, Switzerland. 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?
Patient Health Questionnaire - 9 items (PHQ-9) (time frame: Change from Baseline to post (3mths).). 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 NCT02178631, which also lists 2 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 27 May 2015.