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Trimbos Institute (Netherlands Institute of Mental Health and Addiction), Utrecht, and Department of Clinical Psychology, Free University, Amsterdam
Trimbos Institute, Utrecht
Institute of Medical Technology Assessment, Erasmus Medical Centre, Rotterdam
Trimbos Institute, Utrecht
Department of Clinical Psychology, Free University, Amsterdam, and Trimbos Institute, Utrecht
Department of Psychiatric Epidemiology and Department of Psychiatry, Free University, Amsterdam, and Trimbos Institute, Utrecht, The Netherlands
Correspondence: Filip Smit, Department of Prevention and Early Intervention, Trimbos Institute, PO Box 725, 2500 AS Utrecht, The Netherlands. Tel: +31 30 295 9254; fax: +31 30 297 1111; e-mail: fsmit{at}trimbos.nl
Declaration of interest None. Funding detailed in Acknowledgements.
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMETHODRESULTSDISCUSSIONClinical Implications and...ACKNOWLEDGMENTSREFERENCES |
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Aims To study the cost-effectiveness of care as usual plus minimal contact psychotherapy relative to usual care alone in preventing depressive disorder.
Method An economic evaluation was conducted alongside a randomised clinical trial. Primary care patients with sub-threshold depression were assigned to minimal contact psychotherapy plus usual care (n=107) or to usual care alone (n=109).
Results Primarycare patients with sub-threshold depression benefited from minimal contact psychotherapy as it reduced the risk of developing a full-blown depressive disorder from 18% to 12%. In addition, this intervention had a 70% probability of being more cost-effective than usual care alone. A sensitivity analysis indicated the robustness of these results.
Conclusions Over 1 year adjunctive minimal contact psychotherapy improved outcomes and generated lower costs. This intervention is therefore superior to usual care alone in terms of cost-effectiveness.
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONClinical Implications and...ACKNOWLEDGMENTSREFERENCES |
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METHOD |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONClinical Implications and...ACKNOWLEDGMENTSREFERENCES |
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Sample
Participants (aged 18–65 years) were recruited from 19 general
practices in The Netherlands. Patients were considered to be eligible when
presenting sub-threshold depression defined as having at least one core
symptom plus one, two or three current depressive symptoms according to the
Instel screening instrument (Tiemens
et al, 1995). Exclusion criteria were the presence of
full-blown DSM–IV (American
Psychiatric Association, 1994) depressive disorder, dysthymia,
bipolar disorder, social phobia, agoraphobia or panic disorder in the past 12
months as measured with the Composite International Diagnostic Interview
(CIDI; see ‘Measures’).
Participants were recruited in several steps (Fig. 1). Research assistants screened 3825 patients who were waiting to see their general practitioner. Eligible patients (n=1018) were asked to give their informed consent to participate in the trial. Of these, 363 were willing to do so and received a computer-assisted diagnostic interview with the CIDI. This was done to exclude patients with full-blown depression and other DSM–IV Axis I disorders as specified above. The randomisation was done centrally, using blocked randomisation stratified by general practice with the patient as unit of randomisation, with blocks of four patients. Eligible patients who had given their informed consent were randomised, with equal probability, to receive minimal contact psychotherapy adjunctive to usual care (n=107) or to usual care alone (n=109). Of these, 83 in the intervention group and 94 in the usual care group were retained in the trial after 12 months. Fewer participants completed the economic questionnaire: at baseline, questionnaires were completed by 99 members of the intervention group and 102 of the usual care group, of whom 75 and 87 respectively completed the questionnaires at follow-up.
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Intervention
The experimental intervention was cognitive–behavioural minimal
contact psychotherapy for depression, based on the Dutch version
(Cuijpers, 2000) of the
‘Coping with Depression’ course
(Lewinsohn et al,
1984). The main component was a self-help manual with instructions
on mood management. The self-help therapy was guided by six short telephone
calls with a prevention worker. The control intervention was care as routinely
provided by the general practitioners. All participants, in both conditions,
could make use of all other types of health services during the intervention
period.
Clinical measures
The participants’ DSM–IV depression status was assessed with
the CIDI–Auto 2.1 (World Health
Organization, 1997) in its Dutch version
(Ter Smitten et al,
1998). The CIDI is a standardised diagnostic interview for the
assessment of mental disorders, developed by the World Health Organization. It
was designed for use by trained lay interviewers, has high interrater and
test–retest reliability and good validity for affective and anxiety
disorders (Wittchen, 1994;
Andrews & Peters, 1998).
The interviews were carried out over the telephone. This should not have
affected the results in any meaningful way
(Rohde et al, 1997;
Evans et al, 2004).
Depressive symptoms were measured using the Centre for Epidemiological Studies
– Depression scale (CES–D;
Radloff, 1977), Dutch version
(Bouma et al, 1995), a
widely used self-report scale measuring the frequency of 20 depressive
symptoms during the past week. The CES–D generates a total score that
can range from 0 to 60, with a higher score indicating more depressive
symptoms. The Dutch translation has good reliability and validity
(Bouma et al,
1995).
Measuring resource use
For this study we adopted a societal perspective, including the costs of
all types of health services and the costs that stem from production losses.
The time frame of this study was restricted to 1 year. Therefore, we did not
correct for inflation and did not discount costs. All costs are expressed in
euros (
) for the reference year 2003 on a per capita basis for the
period of 1 year.
Information on the participants’ use of health services was obtained with the Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC–P; Hakkaart-van Roijen et al, 2002). With this questionnaire patients register the number of general practice visits, sessions with psychiatrists, hospital days, etc. In addition, the number of ‘work loss’ days (absenteeism from work) and the number of ‘work cut-back’ days (reduced efficiency at work while feeling ill) were also measured with help of the TIC–P.
Cost of services
The intervention costs of minimal contact psychotherapy were 124 for
screening and a further 124 for the intake, plus 31 per additional
contact over the telephone with a maximum of six calls. Patients had to pay
25.50 for the self-help manual. The patients’ time for working
through the self-help manual was valued at 8.30/h, assuming that they
would carry out their assignments after office hours. It should be noted that
the intervention costs occurred only in the experimental group during the
actual uptake of the intervention over 4 months.
Direct medical costs are the costs of treatments offered by a broad range
of both formal and informal health service providers
(Table 1). Medical services
were costed by multiplying the number of health service units (consultations,
hospital days, etc.) by their standard cost price (Oostenbrink et al,
2002,
2004). To these we added the
costs of antidepressants, calculated as the cost price per standard daily dose
as reported in the Pharmaceutical Compass
(http://www.fk.cvz.nl),
plus 6% value added tax, multiplied by the number of prescription days, plus
the pharmacist’s dispensing costs of 6.45 per prescription.
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Direct non-medical costs arose when patients travelled to health service
providers and paid for parking. These ‘out-of-pocket’ costs were
valued at e0.16/km and 2.50/h parking time. To this we added the costs
of the patients’ time spent in travel, waiting and in treatment at
8.30/h (Table 1).
Cost of production losses
Indirect non-medical costs arise when production losses occur owing to
illness. Three situations can be encountered here. First, people can be absent
from paid work. To evaluate a lost day in a paid job we used age- and
gender-specific ‘friction costs’ obtained from Oostenbrink et
al (2004). Friction costs
represent the monetary counter-value of production losses that occur during
absence from work with a limit of 5 months
(Koopmanschap et al,
1995). Second, production losses also occur when people are ill
but continue to work with reduced efficiency. We estimated the number of work
cut-back days as the number of days actually worked when ill, multiplied by a
self-reported inefficiency score, which ranged between 0 and 1 (0, as
efficient as when in good health; 1, totally inefficient). Again, we used
friction costs to valuate these production losses. Third, people may also be
too ill to perform domestic tasks. These costs were evaluated at the price of
domestic help at 8.30/h.
Statistical analysis
The analysis of clinical outcomes was conducted in accordance with the
intention-to-treat principle. Use was made of the regression imputation
procedure as implemented in Stata version 7.0 for handling loss to follow-up.
In the regression imputation model, baseline CES–D scores, age and
gender were used as predictors, because they were significant predictors of
depression status at follow-up. Since patients were recruited from 19 general
practices, some degree of clustering in the data had occurred. Clustering
violates the assumption of independence of observations, and may thus affect
standard errors and P values. This was handled with the help of
so-called robust standard errors, which were obtained using the first-order
Tailor series linearisation method as implemented in Stata. The incidence rate
ratio (of the incidence rate in the intervention group over the incidence rate
in the usual care group) was obtained by regressing (the imputed) depression
status at follow-up on the treatment dummy in a Poisson model, while taking
into account the clustering effect. The statistical test was conducted at
<5 < 0.05, one-sided, because inferior effectiveness of
adjunctive psychotherapy over usual care alone was not expected.
Analysis of costs
The analysis of costs was also conducted in agreement with the
intention-to-treat principle. Missing cost data at follow-up were imputed as
before, but now with costs at baseline, age and gender as predictors. We
report the mean annual per capita costs of the intervention, plus the direct
medical, direct non-medical and indirect costs and some of their components
(see Table 2). This was done
for both trial arms and for the differences between the two study groups. The
corresponding tests were based on 2500 bootstrap replications because cost
data are non-normally distributed.
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Analysis of cost-effectiveness
In the cost-effectiveness analysis health effects (depression-free
person-years) and costs in both treatment arms were computed by means of
non-parametric bootstrapping (2500 times) of the individual patient data with
respect to both incremental costs and incremental health effects. The
comparison of the simulated differences in costs and health effects is
presented in a cost-effectiveness plane (see
Fig. 2), with differences in
costs on the vertical axis and differences in health effects on the horizontal
axis. If the intervention appears in the top left-hand quadrant of the plane,
higher costs are paid for lower effectiveness; the intervention is then
unacceptable from a cost-effectiveness perspective, and conventional care
remains the treatment of choice. If the intervention appears in the lower
right-hand quadrant, lower costs are then associated with positive health
effects; the intervention dominates and is acceptable. In the other two
quadrants, higher (or lower) cost levels have to be weighed against greater
(or lesser) effectiveness.
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RESULTS |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONClinical Implications and...ACKNOWLEDGMENTSREFERENCES |
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Health effects
At 12 months, the incidence rate of depressive disorder was 11.9% in the
adjunctive psychotherapy group 
. 18.3% in the group receiving usual care
only. The incidence rate ratio (IRR) was therefore 11.9/18.3=0.65, and the 0
hypothesis of inferior clinical effects in the intervention condition had to
be rejected (IRR=0.65, s.e.=0.15, t=–1.82, P=0.04,
one-sided), favouring the conclusion that adjunctive minimal contact
psychotherapy is more successful than usual care alone in reducing the
incidence of depressive disorder (Willemse
et al, 2004).
Costs
Over 1 year the adjunctive psychotherapy group incurred the costs of the
intervention (on average 423), but these additional costs were partly
compensated for by savings elsewhere in the medical sector
(Table 2): the mean difference
of the direct medical costs was 60 (s.e.=555) in favour of care as
usual, but this was not statistically significant (P=0.914).
Moreover, the out-of-pocket costs of the patients in the intervention
condition were somewhat lower (441 . 507 in the usual care
condition), representing a difference of 66 in favour of the
intervention. Avoiding production losses resulted in further cost savings. The
mean cost of the production losses was 4638 in the intervention
condition against a higher 6481 in the usual care condition, resulting
in an average saving of 1843. Overall, the mean annual per capita total
cost in the intervention group was 6766, which compares favourably with
the 8614 in the usual care group. The overall savings average 1849
when the psychotherapy intervention is added to care as usual, but this is
statistically not significant (95% CI –5169 to 1472; P=0.281).
Nevertheless, it is worth noting that there is a large probability that the
costs of the intervention are balanced by savings elsewhere. We return to this
point shortly.
Cost-effectiveness
The incremental cost-effectiveness ratio was calculated as
(C1–C0)/(E1–E0),
where C is the average annual per capita cost and E is the
percentage of people who did not develop depression in the experimental and
control conditions (subscripted 1 and 0 respectively). In other words, the
incremental cost-effectiveness ratio is the difference of mean costs between
the conditions divided by the difference in effect. Substitution yields
(6766–8614)/(88.1–81.7)=–288.75. Hence, for each case of
depression that can be avoided by offering the experimental treatment instead
of care as usual, a saving is made of 288.75.
The incremental cost-effectiveness ratio is surrounded by a certain amount
of uncertainty. Figure 2
presents the cost-effectiveness plane for the intervention . care as
usual. The incremental costs are plotted on the y axis and the
incremental effects on the x axis. Each dot (n=2500)
represents a bootstrap replication of the incremental cost-effectiveness
ratio; 59% of the dots are in the lower right-hand quadrant, indicating a 59%
probability that minimal contact psychotherapy is the superior treatment,
because it generates better health effects against lower costs when compared
with care as usual. On the other hand, there is a 5% probability that this
psychotherapy is inferior, and there is a 10% probability that it is both less
costly and less effective. A fifth (21%) of the dots fall in the upper
right-hand quadrant, indicating that a health gain is produced, but at
additional costs.
Acceptability
Figure 3 presents the
cost-effectiveness acceptability curve for minimal contact psychotherapy .
care as usual. The solid line curve intersects the y axis at 0.70;
when the willingness to pay for an averted depressive episode is absent (equal
to e0.00), then there is a 70% probability that this therapy is more
cost-effective than care as usual. Generally, people are willing to pay for
avoiding a depressive episode, and minimal contact psychotherapy will be
regarded as good value for money given a – usually unknown –
ceiling for this willingness to pay. Different ceilings are presented on the
x axis. When the willingness to pay is raised to 10 000 per
avoided depression, then the intervention has a probability of 74% of being
cost-effective compared with its alternative; at 20 000 the probability
of an acceptable cost-effectiveness has risen to 80% and at 30 000 it
has reached a 83% probability of being more acceptable than usual care
alone.
Sensitivity analysis
When the indirect costs related to the production losses are excluded, then
the distribution of the bootstrapped cost-effectiveness ratios over the
cost-effectiveness plane is as follows:
Under these circumstances, the psychotherapy intervention has a probability
of 46% of being acceptable when the willingness to pay equals 0 (dotted line
in Fig. 3). When the
willingness to pay is increased to 10 000, 20 000 and 30
000, then the probability of the intervention being more acceptable than usual
care increases to 61%, 70% and 75% respectively.
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONClinical Implications and...ACKNOWLEDGMENTSREFERENCES |
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30 000, then the intervention has a 75% probability of being the
preferred option.
Limitations
This study has several limitations. First, although problems with attrition
are common in randomised trials of psychological interventions in general
practice (Muñoz et al,
1995; Fairhurst & Dowrick,
1996), the representativeness of the sample can be questioned. In
recognition of this limitation, all analyses were conducted in accordance with
the intention-to-treat principle, and imputation was used as a means of
overcoming the missing data problem resulting from loss to follow-up. Second,
it was not possible to mask participants to the condition to which they were
assigned. This is true for most randomised trials of psychological
interventions, but it may nevertheless have distorted the outcomes of our
trial. Third, the study was conducted in The Netherlands, and the results
cannot be reliably generalised to countries that have different primary care
systems. Fourth, the costs and effects were considered in the time-span of 1
year. We do not know how the cost-effectiveness of minimal contact
psychotherapy is affected when a longer period is used. Because of these
limitations, the results of this study should be considered with some
caution.
The wider context
Depression is one of the leading causes of disability
(Ustun et al, 2004).
However, according to one estimate, even under a hypothetical regimen of
optimal (evidence-based) care the burden of depression can only be averted for
about a quarter of patients (Andrews et
al, 2004). This suggests that prevention may have to play a
more important role in public mental health
(Willemse et al,
2004). Reducing the burden of depression by means of a preventive
intervention is possible, as was shown in a randomised clinical trial by
Willemse et al (2004)
and in a meta-analysis of randomised prevention trials by Cuijpers et
al (2005). Perhaps of
equal importance is the opportunity to offer a low-cost, self-help treatment,
which is effective but consumes small amounts of healthcare resources. In
fact, our study showed that there is a 70% probability that minimal contact
psychotherapy as an adjunct to usual care is more cost-effective than usual
care alone. Our findings are in agreement with the reviews of both Churchill
et al (2001) and
Schulberg et al
(2002) and the more recent
cost-effectiveness cost-effectiveness analysis of McCrone et al
(2004). They found that
psychological interventions based on cognitive–behavioural therapy are
cost-effective in primary care patients with depression.
Cognitive–behavioural therapy appears also to be cost-effective for
relapse prevention in chronic depression
(Scott et al, 2003).
In contrast, other types of psychological interventions – specifically
(psychodynamic) counselling and sometimes interpersonal therapy – have
not shown similar effects and cost-effectiveness
(Lave et al, 1998;
Bower et al, 2000;
Simpson et al, 2003).
Now, our study adds the information that a self-help intervention based on
cognitive–behavioural therapy with minimal guidance is cost-effective in
avoiding the onset of full-blown depressive disorder in primary care patients
with subclinical depression.
Directions for the future
The ‘Coping with Depression’ course
(Lewinsohn et al,
1984) and its Dutch version
(Cuijpers, 2000) can be used as
a cost-effective adjunct to conventional primary care in order to reduce the
incidence of depressive disorder. This choice is likely to result in health
gains and economic benefits. Therefore, its dissemination seems appropriate.
Two issues need more in-depth exploration. First, we need to know more about
the cost-effectiveness of this therapy in the long run. Second, the course
should perhaps be adapted for use over the internet; this might help to reduce
the costs of providing this therapy, and at the same time promote its use by a
larger segment of the population.
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Clinical Implications and Limitations |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONClinical Implications and...ACKNOWLEDGMENTSREFERENCES |
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LIMITATIONS
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ACKNOWLEDGMENTS |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONClinical Implications and...ACKNOWLEDGMENTSREFERENCES |
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REFERENCES |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONClinical Implications and...ACKNOWLEDGMENTSREFERENCES |
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Revision received June 28, 2005. Revision received July 12, 2005.
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