© 2007 The Royal College of Psychiatrists
Cost-effectiveness of selective serotonin reuptake inhibitors and routine specialist care with and without cognitive–behavioural therapy in adolescents with major depression
King's College London, Centre for the Economics of Mental Health, Institute of Psychiatry, London;
Biostatistics Group, Division of Epidemiology and Health Sciences, University of Manchester, Manchester
Developmental Psychiatry Section, Department of Psychiatry, University of Cambridge, Cambridge
Department of Child and Adolescent Psychiatry, Royal Manchester Children's Hospital, Manchester
Cambridge Specialist Child and Adolescent Mental Health Service, Brookside Clinic, Cambridge
Department of Child and Adolescent Psychiatry, Royal Manchester Children's Hospital, Manchester
Developmental Psychiatry Section, Department of Psychiatry, University of Cambridge, Cambridge
Department of Child and Adolescent Psychiatry, Royal Manchester Children's Hospital, Manchester
Developmental Psychiatry Section, Department of Psychiatry, University of Cambridge, Cambridge, UK
Correspondence: Sarah Byford, King's College London, Centre for the Economics of Mental Health, Box P024, Institute of Psychiatry, De Crespigny Park, London, SE5 8AF, UK. Tel: 020 7848 01988; fax: 020 7701 7600; email: s.byford{at}iop.kcl.ac.uk
Funding detailed in Acknowledgements.
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Background Major depression is an important and costly problem among adolescents, yet evidence to support the provision of cost-effective treatments is lacking.
Aims To assess the short-term cost-effectiveness of combined selective serotonin reuptake inhibitors (SSRIs) and cognitive–behavioural therapy (CBT) together with clinical care compared with SSRIs and clinical care alone in adolescents with major depression.
Method Pragmatic randomised controlled trial in the UK. Outcomes and costs were assessed at baseline, 12 and 28 weeks.
Results The trial comprised 208 adolescents, aged 11-17 years, with major or probable major depression who had not responded to a brief initial psychosocial intervention. There were no significant differences in outcome between the groups with and without CBT. Costs were higher in the group with CBT, although not significantly so (P=0.057). Cost-effectiveness analysis and exploration of the associated uncertainty suggest there is less than a 30% probability that CBT plus SSRIs is more cost-effective than SSRIs alone.
Conclusions A combination of CBT plus SSRIs is not more cost-effective in the short-term than SSRIs alone for treating adolescents with major depression in receipt of routine specialist clinical care.
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Major depression among adolescents is an important and costly problem but evidence to support cost-effective treatments is lacking (Romeo et al, 2005). This paper reports an economic evaluation of cognitive–behavioural therapy (CBT) plus selective serotonin reuptake inhibitors (SSRIs) compared with SSRIs alone within a randomised controlled superiority trial – the Adolescent Depression Antidepressant and Psychotherapy Trial (ADAPT; Goodyer et al, 2007). It is currently unclear whether combination therapy is more effective than monotherapy, as studies from the USA are conflicting (Clarke et al, 2005; Melvin et al, 2006), and there have been no UK trials in a typical National Health Service (NHS) population. The provision of combination therapy, should it prove effective, would necessitate a shift in resources that could be used elsewhere. Consequently, the cost-effectiveness of CBT plus SSRIs should be determined.
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Hypothesis
The aim of the ADAPT trial was to determine, in a routine sample of adolescents with depression referred to child and adolescent mental health services, whether combination therapy (CBT plus SSRIs) was more effective and more cost-effective than SSRIs alone when provided in addition to routine specialist clinical care. We hypothesised that the additional costs of CBT would be offset by improvements in patient outcomes and/or savings in the use of other services, compared with SSRI treatment alone. Given the focus on patient outcomes, we considered a cost-effectiveness analysis to be the most appropriate method of economic evaluation.
Trial design
Adolescents aged 11–17 years meeting DSM–IV criteria (American
Psychiatric Association, 1994) for major or probable major depression were
recruited to this multicentre randomised controlled trial in Manchester and
Cambridge, UK between June 2000 and November 2004. A brief psychosocial
intervention was undertaken pre-randomisation to exclude participnats with
depression that remit rapidly. Randomisation was carried out by a remote
independent statistical centre. Stochastic minimisation was used to ensure
balance on severity, centre, gender, comorbid behavioural disorder and age.
More detailed information on the brief initial intervention and all other
aspects of the design of this trial are provided by Goodyer et al
(2007).
Interventions
Fluoxetine was chosen as the primary SSRI as it was the only SSRI with
evidence for efficacy from a randomised controlled trial at the start of the
study (Emslie et al,
1997). If fluoxetine was ineffective or causing problematic side
effects, other SSRIs were considered. All participants were seen regularly by
a study psychiatrist for general case management and monitoring of medication.
Participants receiving SSRIs only were offered nine out-patient sessions over
28 weeks; this could be increased depending on clinical need. Participants in
the combined therapy group were also offered weekly CBT for 12 weeks, followed
by six maintenance sessions every 2 weeks and a final session at 28 weeks. CBT
was provided by psychiatrists (who also undertook case management and
monitoring of medication) or CBT therapists (in which case separate sessions
with a study psychiatrist were provided for case management and monitoring of
medication). All therapists had reached pre-agreed competence criteria and
supervision was provided by fully accredited CBT supervisors.
Outcome measures
Research assessors, masked to treatment allocation, carried out assessments
at baseline, 6, 12 and 28 weeks after trial entry. Diagnoses were determined
by the Kiddie Schedule for Affective Disorders and Schizophrenia, present and
lifetime version (K–SADS–PL;
Kaufman et al, 1997).
The a priori primary outcome measure was the Health of the Nation
Outcome Scale for Children and Adolescents (HoNOSCA;
Gowers et al, 1999),
a global measure of mental health impairment scored in the range 0–52
(with higher scores indicating worse outcomes). Secondary analyses explored
cost-effectiveness in terms of quality-adjusted life-years (QALYs), calculated
using the EQ–5D measure of health-related quality of life
(Williams, 1995;
Brooks, 1996). This method of
economic evaluation is known as cost–utility analysis. The EQ–5D
consists of a five-item questionnaire in the domains of mobility, self-care,
usual activities, pain/discomfort and anxiety/depression, which classifies
individuals into one of 243 health states, each associated with a score that
can be used to calculate QALYs. In addition, it contains a visual analogue
scale (VAS) on which patients rate their own health between 0 (worst
imaginable health state) and 100 (best imaginable health state). The measure
has been used extensively and its psychometric properties are adequate
(Brooks, 1996).
Cost
The economic evaluation took a broad service-providing perspective,
including that of the health, social services, education, voluntary and
private sectors. Travel costs to intervention sessions and productivity losses
of the primary carer resulting from their child's illness were also recorded.
Economic information was collected by interview at baseline, 12 and 28 weeks
using the Child and Adolescent Service Use Schedule (CA–SUS), developed
by the authors in previous studies and adapted for this study
(Byford et al, 1999;
Harrington et al,
2000; Barrett et al,
2006). At baseline, information covered the previous 6 months. At
follow-up, service use since the previous interview was recorded. Data on the
trial interventions, CBT and case management/monitoring of medication were
collected from clinical records to avoid patients revealing their treatment
group to the research assessors. All unit costs were for the financial year
2003–04, the most recent financial year over which the trial data were
collected, and are reported in UK pounds sterling. Discounting was not
necessary owing to the short-term nature of the trial.
Intervention sessions were costed on the basis of the salary of the professional involved. Costs included relevant on-costs (employers' national insurance and superannuation contributions) and overheads (administrative, managerial and capital; Curtis & Netten, 2004). Intervention sessions lasted approximately 55 min for the CBT plus SSRIs group and 30 min for the SSRIs group. Indirect time was included using information provided by the trial therapists on the ratio of direct face-to-face contact to all other activities. Although the time the therapists spent in supervision is included in these calculations, supervisor costs were excluded owing to difficulties in accurately separating supervision for the two trial groups. Supervisor costs were estimated and explored in sensitivity analysis. Intervention costs were calculated on the basis of the number of sessions attended; the inclusion of the cost of non-attendance was explored in sensitivity analysis. The cost of the initial clinical assessment and brief pre-randomisation intervention were not included, as these activities took place before randomisation.
Costs of SSRIs and other psychotropic medication were taken from the British National Formulary (British Medical Association & Royal Pharmaceutical Society, 2004). Hospital contacts were costed using NHS Reference Costs (Department of Health, 2004). Unit costs of community health and social services were taken from national publications (Curtis & Netten, 2004). The costs of schooling came from Ofsted reports (the UK inspectorate and regulatory body for schools in England; http://www.ofsted.gov.uk) and published documents (Berridge et al, 2003; Independent Schools Council, 2005). Productivity losses of the primary carer were calculated using the human capital approach, which involves multiplying days off work owing to illness by the individual's salary.
Statistical methods
Analyses were carried out on an intention-to-treat basis using a
statistical analysis plan drawn up prior to data analysis. The analyses were
conducted as for a superiority trial with CBT plus SSRIs as the default
(superior). Although costs were not normally distributed, analyses compared
mean costs using standard parametric t-tests with the validity of
results confirmed using bootstrapping
(Efron & Tibshirani, 1993;
Barber & Thompson, 1998).
The primary analysis was of total cost per young person over 28 weeks.
Multiple regression was used to adjust for the following pre-specified
baseline characteristics: gender, age, centre, HoNOSCA score, severity of
illness (Children's Global Assessment Scale;
Shaffer et al, 1983),
comorbid behavioural disorder (K–SADS–PL) and costs, in all tests
of differences in costs and outcomes. The impact of drop-out was assessed by
comparing baseline characteristics of participants with and without full
economic data. Subgroup analyses by centre and severity of illness were
performed using tests of interaction.
Cost-effectiveness was explored through the calculation of incremental cost-effectiveness ratios (ICER), defined as the difference in mean costs divided by difference in mean effects (Van Hout et al, 1994). Non-parametric bootstrapping (repeat re-sampling) from the costs and effectiveness data was used to generate a joint distribution of incremental mean costs and effects for the two treatments (Efron & Tibshirani, 1993). This was then used to calculate the probability that each of the treatments is the optimal choice, subject to a range of possible maximum values (ceiling ratio) that a decision-maker might be willing to pay for a unit improvement in outcome. Cost-effectiveness acceptability curves are presented by plotting these probabilities for a range of possible values of the ceiling ratio (Fenwick et al, 2001). These curves incorporate the uncertainty that exists around the estimates of expected costs and expected effects associated with the two interventions (Fenwick & Byford, 2005).
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Participants
In total 208 adolescents were randomised to CBT plus SSRIs (n=105) or SSRIs alone (n=103). Full economic data were available for 188 participants (90%), 96 in the CBT plus SSRIs group and 92 in the SSRIs group. Comparison of baseline characteristics revealed a significant centre difference between those included in the economic evaluation and those who were missing, with 95% of missing data coming from Manchester (P=0.015). No other significant differences were found and there was no difference in missing data between the two treatment groups. Although final follow-up was planned to take place 28 weeks after trial entry, this was not always achieved. Attempts were made to include all participants, so earlier and longer follow-ups were allowed. For this reason, length of follow-up varied greatly (range 21–51 weeks); however, there was no significant difference between the two treatment groups (mean 29 weeks in both groups). In addition, there were no significant differences in baseline characteristics between the two treatment groups (Table 1).
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Table 1 Baseline characteristics of the sample
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Outcomes
Results for the HoNOSCA and EQ–5D at the 28-week follow-up are
reported in Table 2. The two
groups did not differ significantly on either measure, nor were any
differences found at the 12-week follow-up
(Goodyer et al,
2007). EQ–5D utilities and self-rated health status from the
visual analogue scale show improvements in health status over time in both
groups, but there was little difference between the two groups at final
follow-up.
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Table 2 Outcome according to treatment group
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Resource use
Table 3 details the mean
number of contacts participants had with all services over the 28-week
follow-up. Resource use differed little between the two groups except for
intervention sessions and in-patient services, with the CBT plus SSRIs group
attending more intervention sessions and spending more time in hospital than
the SSRIs group.
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Table 3 Use of resources by young people during the 28-week follow-up period
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Costs
The mean cost of intervention sessions for the CBT plus SSRIs group was
estimated to be £67 (range £41–£216 depending on
profession and seniority of therapist), compared with £36 for the SSRIs
group (range £22–£118). Assuming full attendance, the cost
of a full course of CBT plus SSRIs was estimated to be £1273 (range
£779–£4104). The actual cost per study participant was
£750 since few completed the full course of treatment owing to
non-attendance or a clinical decision to discharge the participant.
Table 4 details the total costs over the 28-week follow-up. Results from the non-parametric bootstrap replications did not differ substantially from the parametric results and are not reported here. Total costs per participant in the CBT plus SSRIs group were £6940, which was £2300 more than in the SSRIs group. This difference was not statistically significant but came close (P=0.057). The CBT plus SSRIs group incurred significantly greater costs than the SSRIs group in terms of intervention sessions and secondary healthcare services. The difference for intervention sessions was due to the greater length of these sessions and higher attendance rates in the CBT plus SSRIs group. The latter difference was owing primarily to two participants in the CBT plus SSRIs group who were admitted to hospital for a significant proportion of their time in the trial (65% and 92%, respectively). Differences between the two groups were almost entirely due to differences in the cost of admissions. To take into consideration the variable length of follow-up costs per week are also reported but this made no difference to the results (P=0.059). In subgroup analyses, there were no statistically significant differences in the estimated effect of CBT plus SSRIs on total cost by centre (test of interaction P=0.412) or severity of illness (P=0.971).
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Table 4 Total service cost per participant over the 28-week follow-up period
(£)
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Sensitivity analysis
A number of one-way sensitivity analyses were undertaken.
- The cost of intervention sessions was based on the salaries of the
professionals involved. Since the seniority of the therapists may have been
influenced by the research, these costs were recalculated to reflect likely
clinical practice using the following professionals: specialist registrar,
clinical psychologist grade A and mental health nurse grade F/G.
- The main analysis excluded sessions where the participant did not attend,
which assumes the therapist was able to use the time for alternative
productive work. This assumption was removed and the full cost of participants
not attending was included (equivalent to the cost of an attended
session).
- Estimates of the cost of supervisors' time was added on the basis of the
following assumptions: supervision provided by a consultant psychiatrist; mean
of ten intervention sessions per week; mean of 60 min of supervision per week;
mean of 6 min of supervision per session per week.
- The impact on cost of the two participants who spent the majority of the
trial in hospital was explored by excluding these from the analysis.
- Travel and productivity losses borne by parents were added to provide a
broader cost perspective.
- Local costs were changed to national unit costs
(Curtis & Netten, 2004) to
assess generalisability to the wider UK population.
The majority of these analyses did not alter the finding of no significant difference in cost between the two groups (Table 5). Inclusion of the full cost of a participant not attending and supervisors' time increased the difference in cost between the two groups to the extent that the CBT plus SSRIs group became significantly more expensive than the SSRIs group (P=0.049 in both analyses). The removal of the participants who spent most of the trial in hospital greatly reduced the difference in cost (P=0.202).
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Table 5 Sensitivity analysis of 28-week cost per participant (£)
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Cost-effectiveness analysis
Using the bootstrapped means, the CBT plus SSRIs group cost £2327
more than the SSRIs group and HoNOSCA scores were 0.81 points worse over 28
weeks, giving an ICER of £2873 per unit increase in HoNOSCA score, where
higher scores indicate worse outcomes.
Figure 1 presents a scatterplot
of the bootstrapped replications for incremental cost and incremental HoNOSCA
score on the cost-effectiveness plane. Because poorer outcomes on the HoNOSCA
are associated with higher scores, moving from left to right on the
x-axis means a worsening in the incremental effectiveness for the CBT
plus SSRIs group compared with the SSRIs group. The standard
cost-effectiveness plane is therefore reversed. In the north-west quadrant,
the experimental intervention is more costly and more effective, whereas in
the northeast quadrant the experimental intervention is more costly and less
effective. The scatterplot demonstrates that CBT plus SSRIs is more expensive
than SSRIs for almost all replications (points above the x-axis) and
is associated with poorer outcomes for a large proportion of replications
(points to the left of the y-axis).
Figure 2 illustrates the
associated uncertainty. At a ceiling ratio of £50 000, the highest value
shown, there is a 25% chance of CBT plus SSRIs being more cost-effective than
SSRIs alone. Tests beyond this value (up to a ceiling ratio of £150 000)
found that the probability of CBT plus SSRIs being more cost-effective than
SSRIs alone did not rise above 26%.
 View larger version (23K): [in a new window] [as a PowerPoint slide] |
Fig. 1 Cost-effectiveness plane showing the bootstrapped mean differences in costs
and effects using the Health of the Nation Outcome Scale for Children and
Adolescents (HoNOSCA). CBT, cognitive–behavioural therapy; SSRIs,
selective serotonin reuptake inhibitors.
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 View larger version (9K): [in a new window] [as a PowerPoint slide] |
Fig. 2 Cost-effectiveness acceptability curve for Health of the Nation Outcome
Score for Children and Adolescents (HoNOSCA) showing the probability that
selective serotonin reuptake inhibitors (SSRIs) plus cognitive-behavioural
therapy (CBT) is more cost-effective than SSRIs alone.
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Outcomes
The combination of CBT with SSRIs did not result in significant clinical benefits for adolescents with major depression compared with SSRIs alone over 28 weeks. Health-related quality of life showed consistent improvements over time in both groups, but there were no between-group differences. Although improvements were evident in the group as a whole (mean baseline EQ–5D self-rated health status score 57, increasing to 72 at 28 weeks), these participants were still reporting scores lower than the UK population norm for young people under 25 years of age (mean 86.49; Kind et al, 1999).
Costs and cost-effectiveness
The CBT plus SSRIs group was more expensive over the 28-week follow-up than
the SSRIs group, but not significantly so. However, the addition of the cost
of participants failing to attend sessions and the cost of supervisors' time
increased this cost difference to the extent that the CBT plus SSRIs group
became significantly more expensive in both analyses. Since the cost of
supervisors' time is a realistic cost to include, these results strongly
suggest that CBT plus SSRIs is significantly more expensive than SSRIs
alone.
Cost-effectiveness analysis further emphasised the lack of evidence in favour of CBT plus SSRIs. Irrespective of the measure of outcome chosen, there was no evidence to support the hypothesis that CBT plus SSRIs is a more cost-effective strategy than SSRIs alone for adolescents with major depression in receipt of routine care. Cost-effectiveness acceptability curves suggest that there is at best a 26% probability that CBT plus SSRIs is more cost-effective than SSRIs alone in terms of the HoNOSCA and only a 4% probability in terms of QALYs. Even when the two participants receiving CBT plus SSRIs who spent most of the trial in hospital were excluded in an attempt to bias the results in favour of CBT plus SSRIs, the probability of being cost-effective remained less than 50%. Thus, the sensitivity of the cost results to changes in the assumptions upon which the costs are based did not alter the overall findings.
Limitations
Analysis of participants excluded owing to missing economic data found a
significant centre difference, with a higher proportion of missing data in
Manchester than Cambridge. However, follow-up rates were relatively high
overall (90%) and there is no evidence to suggest the comparison of the two
groups was biased as a result of missing data. Despite intensive efforts to
maintain therapeutic contact, mean attendance rates for CBT were low (11 out
of 19 sessions), which may have reduced the response. However, this was a
pragmatic trial and these rates reflect the clinical reality of attendance in
this population of young people. The results are unable to provide evidence of
the relative cost-effectiveness of CBT only; however, it was not considered
appropriate to deny SSRIs to a population with such severe illness, given the
existence of evidence to support their effectiveness, particularly for
fluoxetine (Emslie et al,
1997; Whittington et
al, 2004). The results presented here are short-term,
covering only the 28-week treatment period. The longer-term impact of the
interventions is unknown.
Other evidence
Despite these limitations, this study presents the only evidence of the
cost-effectiveness of combination therapy for a pragmatic sample of
adolescents with major depression. One similar study carried out in the USA
explored the use of health services (Clarke
et al, 2005), providing some indication of resource
implications. The study evaluated a collaborative care, CBT programme for
adolescents with major depressive disorder as an addition to treatment as
usual (consisting primarily of SSRIs) and found significantly fewer
out-patient visits and a lower use of medications in the CBT group compared
with treatment as usual. However, since service use was not costed, it is not
possible to determine whether these resource use differences would have
translated into significant cost differences.
Only one cost-effectiveness analysis of individual treatments was located (Haby et al, 2004). Haby et al, undertook a modelling exercise to explore the cost-effectiveness of CBT and SSRIs, both compared with current practice. They concluded that CBT provided by a public psychologist was the most cost-effective option for the first-line treatment of major depressive disorders. However, this study was based on many assumptions and data from sources of varying quality, including expert opinion. The sample was much broader than that of the current study, including both children and adolescents, and the economic perspective was much narrower, including only the cost of the interventions. Although providing the only other evidence of cost-effectiveness of treatments for depression in young people, the relevance of this Australian modelling study to UK clinical populations is uncertain.
Policy implications
Guidance for the treatment of depression in children and adolescents in the
UK states that antidepressant medication should not be offered to children or
young people with moderate or severe major depression except in combination
with a concurrent psychological therapy
(National Collaborating Centre for Mental
Health, 2005). For adolescents in receipt of routine specialist
clinical care, the results of the ADAPT trial do not support the combination
of CBT and antidepressants over antidepressants alone, either in terms of
effectiveness or cost-effectiveness, over the short to medium term. The
findings suggest that the provision of SSRIs in addition to routine care has a
higher probability of improving outcomes in a cost-effective manner over the
first 6 months of treatment. This finding was robust to changes in the
underlying cost assumptions and, given the pragmatic nature of the trial, is
generalisable to clinical samples of adolescents with major depression in the
UK.
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Richard C. Harrington (deceased) was the original principal investigator responsible for the protocol and trial management. The study was funded by a UK NHS Health Technology Assessment Research and Development grant, Central Manchester and Manchester Children's University Hospitals NHS Trust and the Cambridge and Peterborough Mental Health Trust.
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