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The effectiveness of blended treatment for depression: combining face-to-face and online therapy


- candidate number21280
- NTR NumberNTR4962
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jan-2015
- Secondary IDs603098 Grant agreement nr for Collaborative Project, funded by EU-FP7
- Public TitleThe effectiveness of blended treatment for depression: combining face-to-face and online therapy
- Scientific TitleThe (cost-) effectiveness of blended Cognitive Behavioural Therapy (bCBT) for Major Depressive Disorder in specialised mental healthcare: E-COMPARED trial in The Netherlands
- ACRONYM
- hypothesisBlended depression treatment is as effective as regular treatment, but teh blended treatment is more cost-effective.
- Healt Condition(s) or Problem(s) studiedDepression, Major depressive disorder (MDD)
- Inclusion criteria- Being 18 years of age or older. - Meet DSM-IV diagnostic criteria for MDD as confirmed by the telephone administered MINI International Neuropsychiatric Interview version 5.0 and a score of 5 or higher on the PHQ-9 screening questionnaire. - Provide signed informed consent.
- Exclusion criteria- Having current high risk for suicide according to the M.I.N.I. Interview section C. - Having serious psychiatric co-morbidity as established in the M.I.N.I. interview, i.e. bipolar affective disorder, psychotic illness, substance dependence and obsessive compulsive disorder. - Currently receiving psychological treatment for depression in primary or specialised mental health care. - Being unable to comprehend the spoken and written Dutch language. - Not having access to an internet connection. - Not willing to carry an Android smartphone during the duration of treatment.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2015
- planned closingdate1-jan-2017
- Target number of participants150
- InterventionsBlended Cognitive Behavioural Therapy (bCBT): combines individual face-to-face CBT with CBT delivered through an Internet-based treatment platform (ICT4Depression). This platform is connected to a mobile phone application which will be used for the monitoring of patients mood state (ecological momentary assessment: EMA) and automated feedback and motivational messages (ecological momentary intervention: EMI). Eighteen alternating face-to-face and online sessions will be delivered over a period of 18-20 weeks. Treatment as ususal (TAU): the routine care that subjects receive when they are treated for depression in specialised mental healthcare.
- Primary outcomeLevel of depressive symptoms (PHQ-9)
- Secondary outcomeDepressive Symptomatology (QIDS) Diagnosis of depression and comorbid disorders (M.I.N.I.) Health-related quality of life (EQ-5D) Patients' treatment preference Patients' expectancy (CEQ) Patients' satisfaction (CSQ-8, SUS) Working alliance (WAI, WAI-online therapy) Costs-effectiveness of bCBT (using TiC-P)
- TimepointsBaseline, 3, 6 and 12 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES L Kemmeren
- CONTACT for SCIENTIFIC QUERIESMD. PhD. DJF Schaik, van
- Sponsor/Initiator VU University Medical Center, GGZ inGeest
- Funding
(Source(s) of Monetary or Material Support)
European Community’s Seventh Framework Programme grant (EURIPIDES)
- Publications
- Brief summaryIn this study, a randomized controlled trial will be conducted comparing blended Cognitive Behavioural Therapy (bCBT) to treatment as usual (TAU), among patients referred to specialised mental healthcare with a diagnosis of major depressive disorder (MDD) in The Netherlands. The study is part of a large European project (“European Comparative Effectiveness Research on Internet-Based Depression Treatment” (E-COMPARED); www.ecompared.eu), carrying out comparable trials in eight countries.
- Main changes (audit trail)
- RECORD5-jan-2015 - 10-mrt-2015


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