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van CCT (UK)

van CCT (UK)

Internet-based preventive intervention for depression and anxiety: Role of support?

- candidate number3519
- NTR NumberNTR1355
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jun-2008
- Secondary IDsWC2007-066 
- Public TitleInternet-based preventive intervention for depression and anxiety: Role of support?
- Scientific TitleImplementation of Internet-based preventive interventions for depression and anxiety: Role of support?
- hypothesis- Internet interventions without coach are less effective than those with a coach
- The expected smaller outcomes weigh up to the advantages of a much simpler infrastructure, in clinical and economic outcomes
- Healt Condition(s) or Problem(s) studiedDepression, Anxiety, Prevention, Internet-interventions, Support
- Inclusion criteria1. 18 years or older
2. Having symptoms of depression and/or anxiety (as defined by scoring above the cut-off of 16 on the CES-D and/or 8 on the HADS)
3. Having access to a computer with a fast internet connection
4. Being prepared to participate in the study
- Exclusion criteria1 Which are not too severe (1 standard deviation above the population mean on the CES-D, cut-off <39 and/or HADS cut-off <15)
2. Having suicidal intentions
3. Currently under treatment by a mental health specialist
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-jan-2009
- planned closingdate1-dec-2011
- Target number of participants500
- Interventions1. Brief internet-based problem-solving on the Internet (‘self-examination’ treatment) without coaching (but with automated emails at regular times).
2. The same as in 1, but with the possibility for the subject to approach a coach on his or her own initiative (by email).
3. The same as in 1, but with a coach who will actively approach the subject at regular times (once per week, by email)
4. No Internet intervention, but a coach will approach the subject weekly (by telephone) to discuss problems and give general support (non-specific intervention).
5. Only information on depression and anxiety (on the Internet).
- Primary outcomeSymptoms of depression and anxiety
- Secondary outcome- Diagnosis of depression and/or anxiety
- Drop-out from the intervention
- Quality of life
- Economic costs
- Working alliance
- Client satisfaction
- Problem-solving skills.
- TimepointsMeasures are taken at baseline (pre-test), directly after the intervention (post-test, 5 weeks after baseline) 3 months later, and 12 months later.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThere is no doubt that self-help through the Internet is an effective preventive intervention. It is not clear, however, whether it is necessary to offer these interventions with professional support or without.
Furthermore, if professional support is necessary, it is not clear which level of support is needed. The differences between these types of web-based self-help have not been examined well, although this is very important from the point-of-view of implementation. A system without coaching is much more easy to implement than a system with coaching, which needs an infrastructure of coaches, professional training, and an institute which functions as employer for the coaches. In the current project, we directly compare web-based self-help with different levels of coaching and without a coach. We recruit a total of 500 subjects with mild to moderate depression and/or anxiety and assign them at random to one of five conditions:
(1) Web-based problem solving through the Internet (self-examination therapy) without coach;
(2) The same as 1, but with the possibility to ask help from a coach on the initiative of the respondent;
(3) The same as 1, but with weekly contacts with a coach;
(4) Weekly contacts with a coach, but no web-based intervention;
(5) Information only (through the Internet).
As intervention we use the existing website Allesondercontrole, based on the principles of brief problem-solving. An earlier trial showed that it is effective in reducing depression and anxiety. We examine the effects after the intervention, after 3 months, and after 12 months.
- Main changes (audit trail)
- RECORD24-jun-2008 - 25-jul-2008

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