© 2006 The Royal College of Psychiatrists
Outcomes of an effectiveness trial of cognitive-behavioural intervention by mental health nurses in schizophrenia
School of Neurology, Neurosciences and Psychiatry, University of Newcastle upon Tyne, UK
Department of Psychiatry, University of Southampton, UK
Hampshire Partnership NHS Trust, Mulford's Hill Centre, Tadley, UK
Cambridgeshire and Peterborough Mental Health NHS Trust, Lucille Van Geest Centre, Peterborough, UK
School of Neurology, Neurosciences and Psychiatry, University of Newcastle upon Tyne, UK
Department of Statistics, University of Southampton, UK
Correspondence: Professor Douglas Turkington, School of Neurology, Neurosciences and Psychiatry, Royal Victoria Infirmary, Richardson Road, Newcastle upon Tyne NE1 4LP. Tel.: +44 (0) 191 2824842, email: douglas.s.turkington{at}ncl.ac.uk
Declaration of interest None. Trial funded by a research grant from Pfizer.
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Background Little is known about the medium-term durability of cognitive-behavioural therapy (CBT) in a community sample of people with schizophrenia.
Aims To investigate whether brief CBT produces clinically important outcomes in relation to recovery, symptom burden and readmission to hospital in people with schizophrenia at 1-year follow-up.
Method Participants (336 of 422 randomised at baseline) were followed up at a mean of 388 days (s.d.=53) by raters masked to treatment allocation (CBT or usual care).
Results At 1-year follow-up, participants who received CBT had significantly more insight (P=0.021) and significantly fewer negative symptoms (P=0.002). Brief therapy protected against depression with improving insight and against relapse; significantly reduced time spent in hospital for those who did relapse and delayed time to admission. It did not improve psychotic symptoms or occupational recovery, nor have a lasting effect on overall symptoms or depression at follow-up.
Conclusions Mental health nurses should be trained in brief CBT for schizophrenia to supplement case management, family interventions and expert therapy for treatment resistance.
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Most meta-analyses concur that expert cognitive-behavioural therapy (CBT) has proven benefits in research settings in managing residual symptoms, poor insight and poor adherence to treatment regimens in schizophrenia (National Institute for Clinical Excellence, 2002; Pilling et al, 2002). However, randomised clinical trials only prove efficacy in research settings and with specialist therapists. If CBT is to be delivered to the full range of people with schizophrenia within community settings, then effectiveness trials are needed with clinically worthwhile outcomes (Turkington et al, 2003). The largest workforce in regular contact with people with schizophrenia are mental health nurses. Traditionally, these have used case management and psycho-education within a supportive relationship in the community to manage the disorder. Some nurses have been trained to deliver family interventions aimed at reducing relapse, although implementation has been difficult because of the time investment needed (Kuipers, 2000). The question arises of whether training nurses to deliver brief CBT would be of additional benefit. The null hypotheses being tested were that at 12-month follow-up there would be no difference between the two groups (CBT and usual care) in insight, overall symptoms, depression or suicidality, occupational recovery, time to and duration of hospital readmission, and psychotic or negative symptoms.
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The original results from this trial for end of therapy have already been published (Turkington et al, 2002). The original paper provides a full description of the method.
Study population
Lists of patients with ICD-10 schizophrenia
(World Health Organization,
1992) in contact with healthcare services were constructed across
six sites (Belfast, Glasgow, Hackney, Newcastle, Southampton and Swansea) in
the UK. Lists were drawn from in-patient and out-patient case lists, depot
injection and clozapine clinics, community mental health team case lists and
case registers. These patients were not strictly treatment resistant as
defined in other trials of CBT (Sensky
et al, 2000) but most who agreed to enter the trial had
ongoing positive and/or negative symptoms or were at risk of relapse. The
group was representative of people who have not recovered from schizophrenia
but who, with moderate levels of ongoing symptoms, are maintained in the
community and in contact with a community mental health team or general
practitioner (GP).
Sampling method
Patients were excluded from the lists if they were in the process of active
relapse, had a primary diagnosis of substance or alcohol dependence, organic
brain disease or learning disability severe enough to interfere with rating.
Patients were approached for consent and randomised only after permission had
been given by the responsible medical officer and community keyworker.
Randomisation was performed by computer, using blocks of six random numbers,
and stratification was by site on a 2:1 ratio (therapy v. usual
care). This was to allow inter-site comparisons. All usual-care patients were
offered the intervention of cognitive-behavioural therapy at the end of the
final follow-up assessment. The results for the whole group will not be
presented here, but will await further follow-up at 24 months from baseline.
The study was initially powered using a pilot study of brief CBT
(Turkington & Kingdon,
2000) to give a 90% chance of detecting a 25% level difference in
overall symptoms at the 0.01 level of significance.
Assessments
Raters were trained in the use of the rating instruments before the
beginning of the trial (intraclass correlation coefficient=0.71). To protect
masking, therapists asked patients not to say anything about CBT to the
raters, and raters were informed that a random sample of usual-care patients
would be sent a sample of the CBT materials (this was not carried out in
practice). The primary outcomes were measured by validated rating scales.
Overall symptoms using the Comprehensive Psychopathological Rating Scale
(CPRS; Åsberg et al,
1978), insight using the Insight Rating Scale (IRS;
David, 1990) and depression
Montgomery-Åsberg Depression Rating Scale (MADRS;
Montgomery & Åsberg,
1979) were all measured. Secondary outcomes measured included
positive symptoms using the Psychotic Symptom Rating Scales (PSYRATS;
Haddock et al, 1999)
and negative symptoms using the Negative Symptom Rating scale (NSRS;
Hansen et al, 2003).
Occupational recovery was assessed from a full masked perusal of the
case-notes over the follow-up period. Evidence was logged of return to work
(full-time or part-time) or resumption of education or training. Relapse was
defined as readmission to hospital. Time to and duration of readmission were
logged masked to treatment group at the 12-month time point. Results were
independently analysed following entry into a central database. Medication
changes from end of therapy were recorded as was the number of atypical
antipsychotic drugs used over the follow-up period.
Treatment groups
Mental health nurses were trained over a period of 10 days. Only one of
these (J.P.) had a higher qualification in CBT for schizophrenia. He acted as
a trainer/supervisor for the other nurses who, although experienced in working
with schizophrenia in community settings, had no basic knowledge of CBT.
Training involved a description of the key stages of therapy (Kingdon &
Turkington, 1994,
2005), beginning with
discussion with the nurses about formation of a therapeutic alliance with the
patient and developing normalising explanations for psychotic symptoms. Next,
nurses were taught how to make a therapeutic assessment and then develop a
formulation of the onset and maintenance of psychotic symptoms. Thereafter,
cognitive-behavioural techniques were demonstrated for managing troublesome
psychotic symptoms (hallucinations, delusions and negative symptoms). Further
sessions addressed improving concordance with antipsychotic medication,
developing more functional beliefs concerning self and others, and developing
a personalised relapse prevention plan. Thus, the nurses were being trained to
achieve good engagement and then to work flexibly using cognitive-behavioural
techniques to improve the patients' understanding, develop their coping skills
and help them to take more control over their illness. Role-play (and
role-reversal) exercises were practised to develop confidence in technique
application at each stage of therapy. Numerous case examples were worked
through (Kingdon & Turkington,
2002). After training, weekly supervision was provided. A total of
six therapeutic sessions were completed with each patient over 2-3 months. If
the patient agreed, the main carer received three sessions of CBT training so
that he or she could help with understanding the case formulation, managing
psychotic symptoms and preventing relapse.
This brief intervention is technique-based and should not be confused with the formulation-based and schema-focused CBT described by the National Institute for Clinical Excellence (2002) for treatment resistance. Any patient who attended fewer than three therapeutic sessions was classified as having dropped out. Therapeutic sessions were supported by a series of informative booklets prepared specifically for the study. Treatment fidelity was confirmed independently by two psychologists who rated a randomised selection of taped sessions with the Cognitive Therapy Scale modified for psychosis (CTS-Psy; Haddock et al, 2001). The mean score was 38.4 (95% CI 35.78-41.9) with no statistically significant difference between general and specific sub-scales, indicating that cognitive-behavioural techniques were being used in these sessions. Although the scores on the CTS-Psy were relatively lower than the score that might be expected from therapists who had received intensive training to carry out CBT with patients with treatment-resistant psychosis, these scores do indicate that the nurses were employing some CBT techniques in their intervention. Patients randomised to receive treatment as usual received their normal care plan as organised by the community keyworker. All such patients understood that they would be offered the CBT intervention at the end of the study period.
Statistical analysis
Results were analysed independently at the follow-up point using the
Statistical Package for the Social Sciences, version 10 for Windows, on an
intention-to-treat basis. Differences in symptomatic improvement between the
two groups were assessed using analysis of covariance at 12-month follow-up.
The covariates used were baseline measurements for the corresponding dependent
variables. Tests of normality and skewness across continuous clinical
variables were within acceptable limits. Missing data at follow-up were
imputed using a group mean. The total number of days in hospital for each
patient was calculated over the 12 months from baseline and compared between
the two groups using parametric statistics. Time to relapse as measured by
readmission was analysed using a survival analysis according to the
Kaplan-Maier method. Differential rates of occupational recovery between the
two groups were analysed using chi-squared testing.
 View larger version (19K): [in a new window] [as a PowerPoint slide] |
Fig. 1 Participants' flow through the study. CBT, cognitive-behavioural
therapy.
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The flow chart showing numbers of participants in each group and reasons for drop out is shown in Fig. 1.
The patients enrolled in this study were mostly men, unmarried, White and living independently in poor-quality accommodation (Rathod et al, 2005). There were no statistically significant differences between the groups at baseline. In particular, in terms of previous hospital admissions due to schizophrenia, the CBT group had a mean of 4.71 (95% CI 4.09-5.33) with a mean number of days in hospital of 48.52 (95% CI 37.84-59.21). The usual-care group had a mean of 5.18 (95% CI 4.03-6.33) readmissions and 52.01 (95% CI 37.94-66.07) days in hospital. These differences were not statistically significant, nor were baseline medication dosage or numbers of participants on atypical antipsychotic drugs. At baseline, the mean medication dosage in chlorpromazine equivalents was 746.88 mg in the therapy group (95% CI 602.79-890.96) and 886.58 mg in the usual-care group (95% CI 660.72-1112.44). In relation to atypical antipsychotic drugs, 55 people in the CBT group and 25 in the usual-care group were receiving these medications. During the course of the follow-up period, 14 CBT patients and 10 usual-care patients switched onto atypical antipsychotic drugs. During the follow-up period there was no statistically significant difference in medication parameters.
Durable, statistically significant improvements were seen at 12-month follow-up in insight and negative symptoms in the CBT group compared with the usual-care group (Table 1). Actual scores are given, with mean change scores and confidence intervals on each scale, between baseline and 12-month follow-up. Primary negative symptoms, including alogia and affective blunting, were not improved by the intervention. A good clinical outcome was defined a priori as an improvement of 25% or more, giving a number-needed-to-treat for insight of 11 and for negative symptoms of 14. No significant difference was found between the two groups for positive symptoms, overall symptoms or depression.
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View this table: [in a new window] |
Table 1 Baseline scores and change scores (mean, 95% CI) at 12-month follow-up
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A chi-squared test was carried out on 2 x 2 tables, comparing level
of improvement of insight (<25% or 
25%) with improvement or no change
in depression or worsening of depression. These tests were carried out
separately for CBT and usual care and then combined. This revealed a definite
risk of worsening of depression in the usual-care group (relative risk=2.19,
95% CI 1.41-3.43) but not in the CBT group (RR=1.13, 95% CI 0.76-1.68) in
those whose insight improved by >25%. This protective effect of therapy was
highly significant (P=0.001), and the risk of not having CBT and
worsening of depression with improvement in insight, perhaps caused by
psychoeducation or an atypical antipsychotic medication, is clinically
important. Significantly more patients in the usual-care group (38 out of 165)
relapsed by 12-month follow-up than in the therapy group (36 out of 257)
(chi-squared test, P<0.05). Patients in the usual-care group were
significantly more likely to be readmitted to hospital earlier (mean time to
relapse: usual care, 161 days (s.d.=97.19); CBT, 176 days (s.d.=98.29)
(P=0.018, odds ratio=1.84, 95% CI 1.108-3.04)). Those patients who
did relapse in the CBT group tended to be back in hospital for a briefer
period (mean, 50 v. 71 in-patient days (P<0.05)). Taken
together, these results display a highly significant beneficial effect of
brief CBT in relation to readmission to hospital in schizophrenia.
Occupational recovery, as defined by return to work or education on a full- or
part-time basis, was rare in both groups (11 out of 257 in the CBT group and 9
out of 165 in the usual-care group). There was no significant difference in
outcome between the six sites on an intersite comparison on the primary
outcome.
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This study shows that training mental health nurses to deliver brief CBT is safe and effective. The durable effects of the intervention occurred across certain but not all outcome measures. Statistically significant improvement was found for both insight and secondary negative symptoms such as apathy, reduced volition and asociality. This is particularly encouraging in relation to the very modest benefits that can be achieved with negative symptoms even with atypical antipsychotic medication. A sustained improvement in insight would be expected to lead to improved adherence and the use of more effective coping strategies. Interestingly, some patients receiving the therapy showed increased reporting of positive symptoms when insight was improved. This may have been the reason why the eventual result overall for these symptoms was not significantly different between the two groups. Such increased reporting may have been a result of increased or worsening symptoms or it may also have been related to a willingness to disclose symptoms, owing to normalising and reducing stigma and not being readmitted as a consequence. Depression and overall symptoms were shown to be significantly improved at the end of therapy but not significantly at follow-up. One of the most positive results in this study related to the protective effect of CBT on depression in relation to clinically significant improvements in insight. It may be safer for patients expected to make substantial improvements in insight, for example when commencing or recommencing antipsychotic medication and psychoeducation, to consider providing CBT at the same time.
 View larger version (18K): [in a new window] [as a PowerPoint slide] |
Fig. 2. Kaplan-Meier curve of time to relapse over 12 months according to treatment
arm. TAU, treatment as usual; CBT, cognitive-behavioural therapy. Overall
log-rank test P=0.018
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Apart from the symptomatic improvements listed above, patients with schizophrenia treated with brief CBT showed a longer time to readmission (84% increased risk in the usual-care group). They were also significantly less likely to relapse over the follow-up period. When readmitted, they spent significantly less time in hospital (mean of 50 v. 71 days). This is most likely to relate to improved insight and more effective coping styles in the CBT group. In an earlier publication by our group (Rathod et al, 2005) we demonstrated that, following therapy, there was a statistically significant improvement in insight into the need for treatment in the intervention group at 12-month follow-up. Whether this translated into actual adherence was not tested. These levels of improvement are modest in symptomatic terms, although clinically important because of the benefits of reduced admission to hospital. The savings in terms of reduced bed occupancy could repay resources spent on training in CBT and the provision of supervision. If the beds could have been closed to free the finance, £404 000 could have been saved across the six sites. For a medium-sized mental health trust this would equate to the closure of one acute ward, freeing monies to be spent in the community.
Unfortunately, brief CBT does not lead to any increase in occupational recovery. This is an important clinical outcome, and is now being assessed in clinical trials using CBT and vocational rehabilitation. It would seem, however, that this brief dose of therapy could lead to a more integrated discussion across the area of psychosocial management at care programme approach review meetings (Pelton, 2001). It allows wider availability of CBT to the many eligible patients (National Institute for Clinical Excellence, 2002) and prioritisation of patients for more long-term therapy for those requiring it. A further benefit is that the practical aspects of therapy, including reality-testing, shared formulation, graded activity scheduling and the use of a range of coping strategies, bring carers into the process of treatment. Training nurses in CBT has benefits for the patient, carer, the service delivery system and the nurses themselves, who often report improved job satisfaction.
Similar UK/USA pragmatic trials
These findings support those of Hogarty et al
(1997), who showed that
personal therapy, when delivered to patients with schizophrenia in the
community with the support of a carer, showed benefits on symptom control and
reduced readmission to hospital. The possible benefits of brief CBT in terms
of improved adherence to drug treatment parallel the results of Kemp et
al (1996,
1998), who demonstrated
cost-effectiveness over the short and medium terms. This intervention differed
from the above approaches in focus on improved insight into symptom causation
and maintenance, with the development of focused coping strategies and
lifestyle change. The therapeutic approach was able to blend the above
techniques with the relapse prevention techniques of Gumley et al
(2003) to produce an
intervention which was flexible and effective. This paper supports our
previous publication in showing that mental health nurses can safely and
effectively use CBT with stable patients with schizophrenia in community
settings to deliver clinically important outcomes.
Critical appraisal
The problems in interpreting the findings presented here mostly relate to
issues of protection of masking and generalisability. All studies which have
not used an active therapy comparator struggle to fully preserve masking.
Strategies were employed to attempt to protect masking, and suspected breaches
did not appear to confirm loss of masking to any substantial degree. In
relation to generalisability, the nurses were funded by the trial sponsor and
liaised with community mental health teams rather than having emerged from
within their ranks. It still needs to be proven in a further study that nurses
can be trained and can practise CBT with patients with schizophrenia while in
day-to-day working life. Also, although the sample is by and large
representative of patients with schizophrenia with positive and negative
symptoms on nursing case-loads, it may not be representative of the population
with schizophrenia as a whole. Many of the more seriously ill patients,
particularly with dual diagnosis, actively avoid or default from GP or nurse
case-loads and are more likely to refuse to enter clinical trials. This study
now needs to be followed up by a study which controls for the effect of
therapist time. Appropriate controls would include befriending
(Sensky et al, 2000),
supportive counselling (Tarrier et
al, 1998) or psychoeducation
(Carroll et al, 1998).
However, ideally and unlike the studies mentioned above, the control
treatments should be delivered from a position of clinical equipoise using
experts in that therapy to minimise the impact of investigator allegiance
(Paley & Shapiro,
2002).
Implications for services
The more widespread implementation of CBT within mental health nursing
would require an increased number of training places, particularly of the
brief intensive kind employed here. Staff are more likely to be released for a
brief intensive training course than for 1 day per week over several years. An
increase in training courses for psychosocial interventions with a particular
focus on cognitive-behavioural methods would also be needed. At the
supervisory level we would need more postgraduate training courses. This paper
supports the guidelines published by NICE, but also points out the financial
implications of this particular form of evidence-based practice.
Encouragingly, brief CBT offered to patients with schizophrenia and their
carers appears to have beneficial effects, which should encourage training
providers to support the development of more training courses with continuing
supervision from experienced therapists. This intervention would need to be
supplemented by input from expert practitioners, who could deliver a minimum
of 20 sessions for patients with more severe psychosis or comorbid psychiatric
disorders such as substance use or comorbid personality
disorders.
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The following researchers joined the Insight into Schizophrenia Research group during the follow-up period: Rob Dudley, Lee Lanciotti, Paul McCabe and Neshika Samarasekara.
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