|- candidate number||21280|
|- NTR Number||NTR4962|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-jan-2015|
|- Secondary IDs||603098 Grant agreement nr for Collaborative Project, funded by EU-FP7 |
|- Public Title||The effectiveness of blended treatment for depression: combining face-to-face and online therapy|
|- Scientific Title||The (cost-) effectiveness of blended Cognitive Behavioural Therapy (bCBT) for Major Depressive Disorder in specialised mental healthcare: E-COMPARED trial in The Netherlands|
|- hypothesis||Blended depression treatment is as effective as regular treatment, but teh blended treatment is more cost-effective. |
|- Healt Condition(s) or Problem(s) studied||Depression, 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 received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2015|
|- planned closingdate||1-jan-2017|
|- Target number of participants||150|
|- Interventions||Blended 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 outcome||Level of depressive symptoms (PHQ-9)|
|- Secondary outcome||Depressive 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)|
|- Timepoints||Baseline, 3, 6 and 12 months
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| L Kemmeren|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. DJF Schaik, van|
|- Sponsor/Initiator ||VU University Medical Center, GGZ inGeest|
(Source(s) of Monetary or Material Support)
|European Community’s Seventh Framework Programme grant (EURIPIDES)|
|- Brief summary||In 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)|
|- RECORD||5-jan-2015 - 10-mrt-2015|