The goal of the current project is to examine the cost-effectiveness of an internet-based guided self-help intervention(Allesondercontrole.nu) for depression, in mental health care in comparison with usual care. This intervention has beendeveloped…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary clinical outcome measure is the degree of depressive symptoms (as
measured with the Center for Epidemiological
Studies * depression scale (CES-D).
Secondary outcome
Secondary outcomes include remittance (whether or not the patient meets criteria
for a depressive disorder according to the DSM-IV). the level of anxiety, as
measured with the HADS, satisfaction with the
intervention (CSQ-8), and the use of alcohol and or drugs (CAGE). By use of a
diagnostic interview (the CIDI), the
clinical diagnostic status after treatment will be measured as well as the time
to recovery. Quality of life will be measured with
the EQ-5D at baseline and all follow-up measurements. All questionnaires will
be completed via the internet.
Health care consumption and absenteeism will be measured using the TiC-P. This
instrument is used for economic analyses. Information on which care was
received by the patients will be retrieved retrospectively from electronic
health records.
Background summary
Depressive disorders are the fourth burden of disease in the Netherlands , and
are expected to be the first in 2030 in
developed countries. The loss of quality of life for these patients is enormous
and is accompanied by high health care costs.
Fifteen percent of the Dutch population suffers from a major depressive
disorder of which 5.8% in the past year.
The impact of depressive disorder on the patient*s life is enormous. Depression
is associated with serious functional
impairments in the educational, social and occupational domains, together with
losses in quality of life, considerable
economic costs and high levels of service use. Depressive disorders are
commonly treated with pharmacotherapy
and/or cognitive behavioural therapy, as prescribed by the multidisciplinary
guideline for depressive disorders in the
Netherlands.
A considerable number of patients who seek treatment are frequently confronted
with long waiting lists and are often not
provided with evidence-based treatments.
Although several studies have shown that web-based guided self-help for
depression has comparable effect sizes as
face-to-face treatment, this is still not a very commonly used treatment mode
in daily usual care and the cost-effectiveness
in specialized mental health care has not been studied yet. Research shows that
the health care costs of depressed patients
are high. Faster access to adequate treatment has the potential to speed up
recovery and to result in cost savings. Because
patients are treated earlier, indirect costs like presenteeism can be reduced
and expensive therapists replaced by
internet-coaches.
Study objective
The goal of the current project is to examine the cost-effectiveness of an
internet-based guided self-help intervention
(Allesondercontrole.nu) for depression, in mental health care in comparison
with usual care. This intervention has been
developed by the applicants with financial support from the VU University and
ZonMw. This intervention has been examined
and found to be effective in two earlier randomized controlled trials in
depressed patients recruited from the community.
The cost-effectiveness of internet-based guided self-help has not yet been
examined. Considering the high prevalence of and
the high health care costs associated with depression it is important to have
information on the cost-effectiveness of this
intervention.
Study design
In this study, we will use a non-inferiority design in which we will test the
assumption that internet-based guided self-help is
clinically not inferior to care-as-usual in this population, and not more
expensive than usual care for patients with depression,.
After the patient has contacted the mental health care institute by telephone
or email (aanmelding), a research assistant will
contact the patient within two days, conduct a diagnostic interview by
telephone and will screen for in- and exclusion criteria.
Patients who are considered eligible and willing to participate (after informed
consent) are randomly assigned internet-based
guided self-help or care-as-usual.
Intervention
The intervention we examine is the website *Allesondercontrole*, a brief
problem-solving intervention based on cognitive
behaviour therapy. This webbased intervention is available (for research
purposes) and has been examined in two randomized
controlled trials. The intervention takes 5 weeks. During that period the
respondents indicate what they think is important in
their lives, they make a list of their *problems and worries* and they
categorize their problems into three groups: unimportant
(not related to what they think is important in their lives), important and
solvable (these problems are solved by a systematic
problem-solving approach consisting of 6 steps), or important but unsolvable
(for example having lost someone by death,
having a chronic general medical disease; for these problems they make a plan
how to live with it).
The participants are supported by a coach, who gives feedback to the homework
assignments of the participants in brief,
weekly emails. The total amount of time spent on each patient is about one and
a half hour (estimate based on our earlier
trials). The writing of these emails costs about 15 or 20 minutes per week, and
will be done by a coach (nurse or social worker)
of the participating institute.
The coaches will be trained by the psychologists who have developed the
intervention. An independent psychologist will verify
whether the coaches have followed the protocol sufficiently by reading a random
selection of the emails. The coach will be
trained to be a coach, not a psychotherapist. This implies that they only
verify whether the patient has done the homework assignments correctly. They do
not have any therapeutic contact or general supportive role.
Study burden and risks
N/A
van der Boechorststraat 1
1081 BT Amsterdam
NL
van der Boechorststraat 1
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1) Diagnosis of depression according to DSM-IV criteria
2) Patients are enrolled in specialized mental health care
3) Patients are 18 years or older
4) Patients have access to the Internet
5) Patients are motivated for self-help
Exclusion criteria
1) Psychotic or bipolar disorder
2) Increased risk of suicide
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 | NL36353.029.11 |