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Mindfulness-based therapy for people with schizophrenia: randomised control trial and
economic evaluation protocol.
Schizophrenia is a neuropsychiatric disorder characterised by the presence of
psychopathological domains, such as delusions, hallucinations, formal thought disorder,
motor abnormalities and negative symptoms (1).
Although this disorder is not particularly frequent, with an estimated prevalence around 1%
(2), it is one of the most disabling conditions according to the Global Burden of Disease
studies (3, 4).
People with schizophrenia not only suffer from symptoms, but also from the consequences of
stigma, neglect and abuse (5, 6). Indeed, people with schizophrenia are less likely to be
employed (7) or have their own house (8), and they die 15–20 years earlier than the general
In addition, schizophrenia represents a costly condition for patients, caregivers and the
society. For instance, cost-of-illness systematic reviews have calculated prevalence-based
annual costs for schizophrenia ranging from US$94 million to US$102 billion (2013 US
Pharmacological treatment is one of the cornerstone of schizophrenia therapeutics (13),
however, noncompliance is a challenging issue (14) and even with adequate adherence, up to
30% of patients experience partial response (15). Psychosocial interventions have been
developed in order to increment treatment compliance, but also to help people to cope with
their symptoms, reduce relapses and increment social functioning (16).
The specific case of cognitive behavioural therapy (CBT) has received special attention in the
literature, being recommended even in patients who are resistant to pharmacological
treatment (17). In addition, some economic evaluations have demonstrated that CBT is a
cost-effective intervention from a health perspective (18-20).
Mindfulness-based therapy (MBT), by contrast, has only recently started to be used to treat
people with psychosis (21). This is an operationalised intervention that includes the
development of cognitive and affect dimensions to embrace internal experiences, rather than
avoid them (22). This intervention includes guided meditation and can be added to cognitive
Despite initial concerns about the use of meditation in schizophrenia, pilot studies have
demonstrated the feasibility of using MBT for psychosis (24) and clinical trials have shown
that it can alleviate the distress associated with hallucinations and paranoia (25). Two recent
meta-analyses have evaluated the clinical effectiveness of mindfulness-based therapy for
psychosis (26, 27) with favourable results in terms of symptomatology and rehospitalisation
With this evidence, some people have argued that MBT should be included in the clinical
guidelines, as well as CBT (23). However, until the moment of writing this protocol, no
economic evaluation has been done to probe the cost-effectiveness of such intervention.
Hence, a new randomised trial with an economic evaluation is needed to assess whether MBT
for psychosis represent a valuable therapeutic choice.
Policy question and perspective
This research will answer the policy question about whether it is worthwhile to include MBT
in the package of care of people with schizophrenia.
To make this decision the health service perspective is crucial. Since this protocol is intended
to be applied to the UK setting, the NHS and Personal Social Services perspectives will be
considered according to the NICE recommendations (28).
However, schizophrenia has been proven to impact on many areas of people’s lives (7) and
the evidence has shown that most of costs are indirect costs (11). Hence, a broader
perspective seems more appropriate.
In addition, this research could also be relevant to other policy groups interested in the care of
people with schizophrenia, such as non-governmental organisations (NGO), family and
service-user organisations and research agencies.
Therefore, a societal perspective will be taken, including costs related to health and social
care, but also to productivity losses and costs of informal care.
Productivity losses will be included given that people with schizophrenia have a diminished
ability to work. This is partly due to the symptomatology (cognitive and negative symptoms
(1), but also due to the fact that the first episode of psychosis usually occurs in early
adulthood with a chronic course (29).
Although informal care is not mandatory by NICE, there is substantial evidence on the
impact of schizophrenia in family and caregivers (30) and many of such burden could
eventually implies costs for the NHS, because higher proportion of depression and physical
The aim of this study is to assess the clinical and economic value of adding a mindfulness-
based intervention (MBT) to CBT for people with schizophrenia from a societal perspective.
1) To compare effectiveness of CBT plus a MBT intervention versus CBT alone on
short- and long-term clinical outcomes in people with schizophrenia from secondary
2) To evaluate the cost-effectiveness and cost-utility of adding MBT to CBT for people
with schizophrenia from secondary care settings.
The addition of MBT to CBT is associated with less symptomatology amongst people with
schizophrenia compared with CBT alone.
CBT with a MBT intervention results in a more cost-effective intervention compared with
CBT alone, for the UK context.
A two-arm, parallel, randomised, controlled trial of MBT plus CBT in comparison with CBT
Participants will be recruited from secondary care facilities, either inpatient or community
mental health teams. Specialised services, such as early intervention in psychosis services or
assertive teams will be also included.
Patients aged 18 to 64 years with a diagnosis of schizophrenia-spectrum psychosis according
to the DSM-5 or ICD-11 criteria. This includes schizophrenia, schizophreniform disorder,
delusional disorder and schizoaffective disorder.
1. Unwillingness to provide informed consent.
2. Intellectual disability defined as an IQ<80.
3. Active comorbidity with substance misuse without treatment.
4. Decompensated physical comorbidity that difficult the interventions.
5. Refusal to psychological therapies.
The experimental group will receive MBT according to the procedures developed by Segal et
al (32) and adapted to people with psychosis by Chadwick (24). The rationale for this is its
operationalisation and evidence in previous studies (25, 33). Patients will receive mindfulness
sessions twice a week over a period of 12 weeks led by a trained therapist and will be
encouraged to maintain CD-guided meditation practices at home.
This group will maintain treatment according to NICE guidelines (34), including
pharmacotherapy, social support and CBT.
Patients from the parallel arm will receive treatment according to NICE clinical guidelines
(34) as in the intervention group, but without the mindfulness-based module.
The CBT intervention will be defined as 16 one-to-one based sessions, following a treatment
manual to evaluate links between thoughts, feelings and behaviours (34).
The therapists in the experimental group will complete a form after every session, which will
be assessed by a research team member for treatment fidelity. CBT sessions will be recorded
(in both arms) and will be stochastically evaluated.
The primary outcome will be the change in the Clinical Global Impression-Schizophrenia
(CGI-SCH) (35). The rationale for this is that psychological therapies for schizophrenia have
a focus on how people deal with distressing symptoms, instead of only reducing them (36).
The CGI-SCH scale is applicable by clinicians and it permits evaluate the severity and
general functioning. Psychometric evaluations have demonstrated high reliability and high
correlation with other scales such as GAF and PANSS (35).
The main secondary outcome will be the quality-adjusted life years (QALY). For this study,
the SF-6D instrument will be used. This is an instrument developed by Brazier from the SF-
36 (37). The SF-6D has demonstrated advantages over the EQ-5D specifically in people with
schizophrenia, such as to reflect better the severe nature of the condition, being more
sensitive to change, has a normal distribution and lack of ceiling effect (38).
The PANSS (39) will be applied to evaluate more specifically the symptomatology of
schizophrenia and its correlation with CSI-SCH. The Social functioning scale (40) will
evaluate general aspects of recovery.
At baseline, sociodemographic characteristics of participants will be recorded joint with costs
and outcomes measurements. Next assessments with costs evaluation (see forehead) will be
at 3 months (just after the intervention), 6 months and 1 year.
Recruitment and preparation
Patients will be recruited from secondary care facilities from a defined catchment area of
London. Evaluators will be trained in measurement instruments. Inter-rater reliability will be
assessed with practice interviews.
Treatment allocation will be generated by an independent computer-derived random sequence
for purposes of concealment. An administrator will inform to patients, key health-workers
and MBT therapists of the allocation by phone.
The principal investigator and assessors will be blind to the randomisation status of patients.
This will be maintained by providing instructions to patients, their therapists, clinical teams
and caregivers of no revealing randomisation status. In addition, data will be treated with a
unique identification code to storage and management of the electronic database.
The sample size calculations are based on the clinical effectiveness hypothesis.
To detect a mean difference in CGI-SCH of 4 points (which has described as clinically
significant (35)) with a standard deviation (SD) of 4, a two-sided significance level (α) of 5%
and power (1 – β) of 80% would require 17 patients in each arm. However, given the group
modality of the MBT intervention, a cluster effect is likely to be found (41). A new sample
calculation with same means, SD, power and level of significance, but using an intraclass-
correlation of 0.5 and an estimated cluster size of 8 would require 80 participants per arm.
Both analyses were carried out with STATA 14.2, with commands power and clustersampsi
to sample sizes with and without clustering, respectively.
Estimating a conservative drop-out rate of 30%, is planned to be enrol 104 people in each
The design for the economic evaluation of the primary outcome will be a cost-effectiveness
analysis. Differences in costs and CGI-SCH scores in both arms will be used to calculate an
incremental cost-effective ratio (ICER) using the following formula (42):
Fig 1. ICER formula for CEA
Where CMBT is the mean costs in the MBT group; CCBT is the mean costs in the control group;
CGIMBT is the mean CGI score in the treatment arm; and CGICBT is the mean CGI score in the
Uncertainty of the ICERs will be simulated by resampling bootstrapping method with 2000
iterations and simulated means for costs and outcomes will be plotted in the cost-
The same process will be applied to the QALYs from the SF-6D, resulting in a cost-utility
analysis of the effect of MBT. This will permit to inform directly to the decision maker with a
generic measure of health gain (42).
Cost-effectiveness acceptability curves will be provided to estimate the probability that the
adding MBT is cost-effective compared with CBT alone (43). The rationale for this are: 1)
Adding a new intervention is likely to be in the northeast quadrant of the cost-effectiveness
plane; 2) There will be uncertainty in the measurement of costs and outcomes; 3) Is unlikely
to find a statistically significant difference between mean costs, given the sample size
In relation to the perspective of the economic evaluation previously mentioned, relevant
resources will be listed for the health system, formal social care, informal social care and
Direct medical costs will include psychiatric hospitalisation, emergency visits, day-hospital
care, community mental healthcare, medication and general physical care. Hospital- and
community-based staff costs will include those from psychiatrists, GP, nurses and therapists.
Costs of the MBT intervention will be calculated following the people allocated approach
(45). The rationale for this is that groups will be closed at 8 people and every session will run
unless no-one attend. The ratio of direct and indirect time will be extrapolated from a study of
MBT for depression (46).
Costs of formal social care will include supported accommodation and costs of social worker
per hour of contact with patients. Costs of informal care will be calculated based on the
monetary valuation of the time invested by caregivers in assisting the patients (47).
According to recommendations of a taxonomy for resource use measurement (RUM) (48),
this study will calculate resource use in the following way: 1) Source of data: patients and
patient proxies (caregiver or relative); 2) The RUM will be completed by a member of the
research team; 3) It will be administrated in a face-to-face basis; and 4) recorded in an
electronic format following a pre-stabled questionnaire.
The healthcare utilisation will be measured through the Client Socio-demographic and
Service Receipt Inventory (49), which is a recall questionnaire that allow measurement of
health and social care utilisation, specially validated for mental health and with independently
assessment of correlation with computerised records (50). Informal care will be measured by
a face-to-face questionnaire (51) and the productivity losses will be calculated by the World
Health Organization Health and Work Performance Questionnaire (HPQ), a self-report
instrument which estimate the workplace costs of health problems (52).
The valuation of health and social care resources will base on published PSSRU unit costs of
Health and Social Care 2016 (53).
To value the informal care provided by caregivers, because the high burden of people caring
schizophrenic patients (54), the wellbeing method shall be used (55).
Finally, the friction cost approach (56) will be used to value the productivity losses, given the
evidence that overestimation by the human capital approach in schizophrenia (57).
Analysis will be carried-out with an intention-to-treat basis. This means that data will be
analysed according to initially allocated group, independently of withdrawals (58). Missing
data will treated through the multiple imputation method if they miss at random basis (59). If
such assumption is not satisfied, adjustment and modelling mechanisms will be explored
To examine successful randomisation, chi-squared and t-test statistics will be used. Baseline
characteristic with the results of statistical test will be presented in tables with 95%
confidence intervals and p-values less than 0.05 will consider significant.
Differences in the mean score of the outcomes and costs will be compared using the t-test
with adjustment by baseline characteristics and costs values.
As a result of the previously mentioned clustering effect, a multilevel analysis will be carried-
out to take into account the differences in therapists’ performance (41).
Several sensitivity analyses will be carried-out to test assumptions in measurements of costs
and outcomes, as well as for loss of follow-up and missing data.
Presentation of the results
Comparison between costs and outcomes will be presented in the form of ICERs (with
resampled estimations) in a cost-effectiveness plane. Cost-effectiveness acceptability curves
with willingness to pay (WTP) ranging between £0 and £35,000 per QALY will permit to the
policy maker take a decision based on the probability of that MBT be cost-effective.
Ethics arrangements and dissemination
Research Ethics Committee approval will be obtained before the start of the project.
All eligible participant will require a written consent to be included in the trial, which will be
conducted according to the Declaration of Helsinki (61).
The results of this research will be published in peer-review journals, anonymised data will
be accessible for sharing for non-commercial aims and it hopes improve the care of people
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