European Comparative Effectiveness Research on Internet-based Depression Treatment

Not Applicable

• Conditions: F32; F33; Depressive episode; Recurrent depressive disorder

• Registration Number: DRKS00006866
• Lead Sponsor: ehrstuhl für Klinische Psychologie und Psychotherapie Friedrich-Alexander Universität Erlangen-Nürnberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-02
• Study Completion: 2017-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1012

Inclusion Criteria

Patients will be included, if they
a.are 18 years of age or older
b.meet DSM-IV diagnostic criteria for MDD as confirmed by the telephone administered M.I.N.I. International Neuropsychiatric Interview version 5.0 and have a score of 5 or higher on the PHQ-9 screening questionnaire.
c. provide written informed consent in the study, audio- and video assessment and data usage (including data security).

Exclusion Criteria

Patients will be exluded, if they
a. report a current high risk for suicide according to the M.I.N.I. Interview section C,
b.have a serious psychiatric co-morbidity that needs a more specific treatment as substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder established at the MINI interview,
c.currently receive psychological treatment for depression in primary or specialised mental health care,
d.are unable to comprehend the spoken and written language of the country where the study is conducted (i.e. German in Germany),
e.do not have access to a PC and fast Internet connection (i.e. broadband or comparable) or
f.do not have a Smart phone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smart phone during the duration of treatment (participants without a Smartphone will be provided with one by the research team).

Excluded persons will be informed of other treatment possibilities. In the case of an increased suicide risk special preventive measurements will be taken.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The project E-Compared ends on June, the 30st in 2017. The study E-Compared Germany ends with the last interview of the last participant - at the latest in September 2017. The last assessment for all study participants is the M.I.N.I. 5.0. After the last assessment the TAU group gets access to the bCBT. <br><br>Process: <br>0. Pre-Screening (PHQ-9) <br>1. First Online-Questionnaire + Baseline Interview<br>- Treatment -<br>2. Second Online-Questionnaire (3 months after baseline)<br>3. Third Online-Questionnaire (6 months after baseline)<br>4. Fourth Online-Questionnaire + Follow-Up Interview (12 months after baseline)<br><br>All questionnaires will be assessed via online-testplatform (www.unipark.de). Baseline is the date of the randomisation on individual patient level. <br><br>Symptomspecific Questionnaires - primary outcome: <br>The primary outcome is the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001). <br><br>PHQ-9 will be assessed to all 4 measurement points.