No registrations found.
ID
Source
Health condition
Depression, major depressive disorder.
Sponsors and support
Intervention
Outcome measures
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)
Background 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.
Study objective
Blended depression treatment is as effective as regular treatment, but teh blended treatment is more cost-effective.
Study design
Baseline, 3, 6 and 12 months
Intervention
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.
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4838 |
| NTR-old | NTR4962 |
| Other | Grant agreement nr for Collaborative Project, funded by EU-FP7 : 603098 |