F32 F33
Conditions
Interventions
Group 1: bCBT:
A blended cognitive behavioral therapy combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with mobile
Sponsors
Lehrstuhl für Klinische Psychologie und Psychotherapie Friedrich-Alexander Universität Erlangen-Nürnberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Process: 0. Pre-Screening (PHQ-9) 1. First Online-Questionnaire + Baseline Interview - Treatment - 2. Second Online-Questionnaire (3 months after baseline) 3. Third Online-Questionnaire (6 months after baseline) 4. Fourth Online-Questionnaire + Follow-Up Interview (12 months after baseline) All questionnaires will be assessed via online-testplatform (www.unipark.de). Baseline is the date of the randomisation on individual patient level. Symptomspecific Questionnaires - primary outcome: The primary outcome is the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001). PHQ-9 will be assessed to all 4 measurement points. | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptomspecific Questionnaires - Secondary Outcome: In addition to the PHQ-9 we use the 16 item version of the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR) in the US translation (Rush et al., 2003). The diagnosis of depression will be assessed via M.I.N.I. International Neuropsychiatric Interview (M.I.N.I) version 5.0 on telephone. QUIDS and M.I.N.I. are considered as secondary outcomes. Cost effectiveness: To calculate cost effectiveness according to Quality-adjusted-life-years (QALY’s) we use the EQ-5D-5L (EuroQol) and in addition Trimbos andiMTA Questionnaires on Costs Associated with Psychiatric Illness (TiC-P; Hakkaart-van Rooijen, van Straten, Donker, Tiemens, 2002) as well as the Assessment of Quality of Life instrument (AQoL) (Hawthorne, Richardson, & Osborne, 1999). QUIDS-16-SR, EQ-5D-5L, TiC-P & AQoL will be assessed to all 4 measurement points. TheM.I.N.I. will be assised at Baseline and in the 12 month follow up. Additional measurements: Demographic variables, treatment history, treatment expectancies via das Credibility and Expectancy Questionnaire (Devilly and Borkovec, 2000) will be assessed at basline in the online-questionnaire. 3 month after baseline we also use the Client Satisfaction Questionnaire (CSQ-8; Nguyen, Attkinson, & Stegner, 1983), the System Usability Scale (SUS; Brooke, 1996), the short version of the Working Alliance Inventory (WAI-SF; Hatcher & Gillaspy, 2006) for patients and therapists as well as the technologic alliance in the WAI ONline Therapy (Labpsitec, 2014). In Germany there were a few more additional quantitative and qualitative measurement to different measurement points. A table showing all measurements can be asked for via mail. | — |
Countries
Denmark, France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom
Contacts
Public ContactIngrid Titzler
Lehrstuhl für Klinische Psychologie und PsychotherapieFriedrich-Alexander Universität Erlangen-Nürnberg
Outcome results
None listed