in this study we want to examine whether an Internet-based self-help intervention with a coach is more effective than the same intervention without a coach in terms of clinical outcomes, drop-out and economic costs. Moreover, we want to examine…
ID
Source
Brief title
Condition
- Psychiatric disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures are symptoms of depression and anxiety.
Secondary outcome
Secondary outcome measures are diagnosis, drop-out from the intervention,
quality of life, and economic costs. Other secondary outcome measures that may
predict outcome are also studied, e.g. working alliance, client satisfaction
and problem-solving skills.
Background summary
There is no doubt that internet-based self-help interventions for common mental
disorders are effective. Several well-designed randomized controlled trials,
both national and international, have examined internet-based self-help
interventions for mild depression and anxiety showed that these interventions
are effective in reducing these symptoms (Spek et al., 2007, van Straten et
al., 2006). Advantages of these kinds of treatments are, for example, the
reduced time of the therapist (Marks et al., 2003), reduced costs and the
ability to reach populations with mood and anxiety disorders who are not
reached with more traditional forms of treatment (Cuijpers & Riper, 2007). And,
while the use of the Internet increases among the broad public (Mendelson,
2007), it can be expected, therefore, that the use of (guided) self-help
through the Internet will be increasingly used in the prevention of common
mental disorders. Internet guided self help are offered in many forms. For
example, the support given by a coach can vary from more input (Andersson,
Cuijpers. Carlbring, Lindefors, 2007) to minimal contact with a coach
(Christensen, Griffiths, Jorm, 2004). Although the efficacy of internet-based
self-help has been demonstrated sufficiently, it is not clear how these
interventions should be offered tot the population who can benefit from it. A
major issue is whether it is better to offer the intervention with or without a
coach. Advantages of a system without a coach are, for example, the easy and
cheap implementation of it, it does not require a complex and costly structure
of professionals and there is virtually no limit as to how many clients can
enter program, since additional clients will not imply additional therapist
time (Palmqvist, Carlbring & Andersson, 2007). However, there is evidence that
in interventions without a coach the drop-out rate is considerably higher than
in interventions with a coach. (Spek et al., 2007). On the other hand, a system
organization, in which participants have to be assigned to coaches, will
account for high costs and is more difficult to organize, as the coaches have
to be trained, have to have sufficient time and have to be paid. Moreover,
there will be limits on the amount of participants entering the program.
The scope of the population to be reached with Internet interventions without a
coach is much broader than with a coach. However, Spek et al. (2007) found in
their meta-analysis of international studies indications that interventions
without support are effective, but with smaller effect sizes than interventions
in which the user had regular contact with a coach. How large the differences
in effectiveness are between interventions with and those without a coach have
been studied only once and this study had several shortcomings. Moreover, it
has not been examined whether there are differences in drop-out rate and costs
between interventions without and with support, and in particular different
levels of support. These are, however, very fundamental research questions for
the dissemination of these interventions.
Study objective
in this study we want to examine whether an Internet-based self-help
intervention with a coach is more effective than the same intervention without
a coach in terms of clinical outcomes, drop-out and economic costs. Moreover,
we want to examine which level of support by a coach is more effective compared
to other levels of support.
Study design
This study is a randomized controlled trial with four active treatments with
different levels of support and an information only control condition. The
control condition is added to control for the non specific effects of coaching.
The four active treatment conditions are:
1. Brief internet-based problem-solving on the Internet (*self-examination*
treatment, see below) 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).
Intervention
1. Brief internet-based problem-solving on the Internet (*self-examination*
treatment, see below) 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).
Study burden and risks
In our opinion there is a minimal burden and risk associated with
participation.
Van der Boechorststraat 1
1081 BT
NL
Van der Boechorststraat 1
1081 BT
NL
Listed location countries
Age
Inclusion criteria
1) being 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 8 on the HADS); 3) which are not too severe (1 standard deviation above the population mean on the CES-D, cut-off 39 and/or HADS< cut-off 14; Bauma et al., 1995, Olsson et al., 2005); 4) having access to a computer with a fast internet connection; 5) being prepared to participate in the study.
Exclusion criteria
Excluded are subject with severe symptoms of depression (CES-D, cut-off 39 or higher) suicidal intentions and/or currently under treatment by a mental health specialist.
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 |
---|---|
CCMO | NL21483.029.08 |