Department of Psychiatry, University of Newcastle-upon-Tyne, Royal Victoria Infirmary, Newcastle-upon-Tyne
Department of Psychiatry, University of Southampton, Royal South Hampshire Hospital, Southampton
Department of Psychiatry, Homerton Hospital, London
Correspondence: D. Turkington, Department of Psychiatry, University of Newcastle-upon-Tyne, Royal Victoria Infirmary, Queen Victoria Rd, Newcastle-upon-Tyne NEI 4LP, UK. Tel: 0191 282 4842; e-mail: douglas.turkington{at}ncl.ac.uk
Declaration of interest Funding was provided by Pfizer Ltd.
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ABSTRACT |
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Aims To assess the effectiveness and safety of a brief cognitivebehavioural therapy (CBT) intervention in a representative community sample of patients with schizophrenia in secondary care settings.
Method A pragmatic randomised trial was performed involving 422 patients and carers to compare a brief CBT intervention against treatment as usual.
Results Patients who received CBT (n=257) improved in overall symptomatology (P=0.015; number needed to treat [NNT]=13), insight (P<0.001; NNT=10) and depression (P=0.003; NNT=9) compared with the controlgroup (n=165). Insight was clinically significantly improved (risk ratio=1.15, 95% CI 1.01-1.31). There was no increase in suicidal ideation.
Conclusions Community psychiatric nurses can safely and effectively deliver a brief CBT intervention to patients with schizophrenia and their carers.
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INTRODUCTION |
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METHOD |
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Sampling method
The lists were compiled from in-patient and out-patient case lists, depot
and clozapine clinics, mental health keyworkers and Care Programme Approach
registers. Any patient who was deteriorating and who needed in-patient care or
intensive home treatment was excluded from the study. Similarly, any patient
with a primary diagnosis of drug or alcohol dependence, organic brain disease
or learning disability severe enough to interfere with rating was excluded
from entry. Responsible medical officers and keyworkers were approached to
seek permission for the inclusion of their patients and carers in the study.
Where permission was given, the case notes were fully perused and the patients
were approached by the community psychiatric nurse (CPN) employed at each
site. Patients were randomised only after they had given full consent.
Randomisation was conducted by computer-generated blocks of six random numbers
and stratified by site. The results were placed in sealed envelopes and only
opened at the time of treatment allocation. The ratio of active intervention
to treatment as usual (TAU) was 2:1. This was done to improve recruitment and
allow inter-site comparisons. All TAU patients were told that they would
receive the CBT intervention at the end of the follow-up rating period. A
power calculation based on a pilot study
(Turkington & Kingdon,
2000) predicted that with 90 patients at each site (60 receiving
the intervention and 30 receiving treatment as usual) and assuming a 20%
drop-out rate, there was a 90% chance of detecting a 25% difference in overall
symptomatology at the 0.01% level of significance, should such a difference
exist.
Assessments
Independent raters (psychiatrists, nurses and psychologists) were trained
together at the start of the study to ensure interrater reliability across
sites. The intraclass correlation coefficient on measuring overall symptoms
was acceptable at 0.71. Baseline demographic characteristics recorded at study
entry included age, gender, ethnic group, marital status, employment status
and housing status. All patients were seen initially for consenting by the
centre's therapist and asked not to reveal or even hint at their treatment
allocation to the raters. Raters were informed that some study material would
be left with TAU patients to help to preserve the blindness of the
ratings.
Standardised measures were used to assess the primary outcomes of the study at baseline and at the end of therapy (mean 20 weeks). The primary outcome measures were of overall symptomatology (Comprehensive Psychopathological Rating Scale, Åsberg et al, 1978), insight (Insight Rating Scale; David, 1990) and carer burden (Burden of Care Questionnaire; Mueser et al, 1996). Secondary outcome measures included change in schizophrenic symptoms (Schizophrenia Change Scale; Montgomery et al, 1978) and depression (MontgomeryÅsberg Rating Scale; Montgomery & Åsberg, 1979). Measures of patient and carer satisfaction were devised for the purposes of this study. For the patient, the questions covered issues such as quality of therapy relationship, understanding, coping, mood and overall satisfaction. The carer satisfaction questionnaire contained similar questions to be answered in relation to their role as carer. The questions were answered on a seven-point visual analogue scale. Results were sent from each of the six sites to an independent central database for data entry and independent statistical analysis. Details of medication, converted to chlorpromazine equivalents using the World Health Organization's Anatomical Therapeutic Chemical Classification System (World Health Organization, 1993) in the case of typical neuroleptics, along with the number of atypical neuroleptics and pre-study hospitalisation, were taken from the medical case notes. These were then rechecked at the end of the study period to check for any significant differences between the groups. Further assessments of primary outcome scales and of rehospitalisation will be carried out on all groups 9 months after the end of therapy to ascertain whether the effects of treatment are durable.
Treatment groups
For delivery of the active intervention, CPNs received 10 days of intensive
training in the use of CBT. The manual was developed from an original
description of these strategies (Kingdon
& Turkington, 1994) and abbreviated into a phased approach
designed to be supplemented by specific written material. The CPNs were
trained by experts in CBT (D.T. and D.K.) and were tested on their skills
through demonstration, role play and written examination. Supervision was
provided by a variety of methods during the study, including individual, group
and telephone. Patients in the CBT group saw the nurse for a total of up to
six hour-long sessions over a period of two or three months. If the patient's
carer agreed to take part in the programme, he or she received a total of
three sessions over the same time period. Patients who attended less than
three CBT sessions were classified as drop-outs.
All the phases of CBT were included in the brief approach, including assessment and engaging, developing explanations, case formulation, symptom management, adherence, working with core beliefs and relapse prevention. In conjunction with the phased approach, and integral to each session, were a series of ten specially developed educational booklets five for patients and five for carers. The booklets covered treatment, self-care and lifestyle, leisure time and relationships, drug and alcohol advice, symptom management and sources of help, and were worked through in a flexible manner according to the patient's and carer's individual needs. Appropriate homework was generated. All of the patients were treated in the community or, if appropriate, following attendance at depot clinic, community mental health team or out-patient appointments. Carers were seen most often in the family home.
The patients and carers randomised to receive treatment as usual were left to the care of their own community mental health teams but were aware that CBT would be offered at the end of the study period. All assessments carried out in the intervention group were also completed in this group.
Treatment fidelity
All sessions were audiotaped when patients agreed to this. Independent
evaluation of a stratified sample of tapes was carried out using the cognitive
therapy scale modified for psychosis
(Haddock et al, 2001). A cut-off score of 30 was taken as indicating acceptable quality of therapy
analysis. This revealed that the vast majority of sessions were above this
level (mean=38.84, 95% CI 35.78-41.9).
Statistical analysis
Results were analysed using SPSS version 10 and Stata version 6 on an
intention-to-treat basis. Differences between the two groups were assessed
using analysis of covariance and chi-squared tests, with risk ratios
calculated for categorical variables. Tests of skewness and normality across
clinical variables were within acceptable limits. Primary and secondary
outcome measures were assessed in relation to whether there was a significant
difference using intention-to-treat (n=422) analysis of covariance.
The covariates used were treatment group and baseline measurements for the
corresponding dependent variables. Post therapy, missing data were estimated
by calculating the respective post-therapy group means of those patients who
returned for follow-up. These means were entered for those patients who
dropped out. The level of improvement in the main outcome measures indicating
a good clinical improvement was taken as 25%. This was decided on an a
priori basis in relation to other published work. Analysis of clinically
significant results was then carried out using chi-squared tests.
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RESULTS |
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Statistically significant improvements were seen in the CBT intervention group compared with the TAU group (Table 2) in overall symptoms, insight and depression. Of the primary outcome measures, insight, but not overall symptomatology, was clinically significantly improved by CBT compared with treatment as usual (risk ratio=1.15; 95% CI 1.01-1.31). The number needed to treat (NNT; Laupacis et al, 1988) in relation to a good clinical outcome on insight improvement was 10. The NNT for improvement in overall symptoms was 13.
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Most patients were satisfied with the programme, and nearly 57% rated the overall programme as it has helped me more than anything previously to understand my illness. The median total patient satisfaction score was 44 out of a possible 49, and one-third of the 132 patients who completed the questionnaire gave maximum points. Of the 45 carers who completed the questionnaire, over three-quarters were satisfied with the programme. The median total carer satisfaction score was 47 out of 49.
There were no significant differences by the end of the intervention in symptoms of schizophrenia or burden of care on comparing the two groups (Table 2). Also, there was no significant difference between therapists who delivered an intervention of an acceptably high quality. There was a non-significant 3% improvement in the group of patients who had a carer involved compared with those who had no carer involved, indicating no specific benefit by end of therapy analysis. There was one suicide during the treatment period; this occurred in the TAU group. In general, there was no evidence of increased suicidal ideation with improving insight in either group.
Recruitment and drop-out details are presented in Fig. 1. It is of note that there were significantly more drop-outs in the TAU group (22.4%) than in the CBT intervention group (12.5%; P<0.05). Dropouts were not more likely to be more severely ill, less insightful or more depressed, but there was a statistically significantly increased drop-out rate in those patients who were not White (P<0.0001). This group mostly comprised AfricanCaribbean and Black African patients.
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DISCUSSION |
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Service implications
The benefits as shown here support the further dissemination of
psychosocial interventions among CPNs
(Haddock et al, 1994)
and other mental health care professionals. This study supports the
uncontrolled findings from the evaluation of Thorn nursing initiatives, which
also showed benefit (Lancashire et
al, 1997). Engagement rates were very high with CBT and the
drop-out rate in the TAU group was almost twice that in the CBT intervention
group. The impact of ethnicity on drop-out probably relates to problems in
engaging and developing explanations in patients from different cultural
backgrounds. It may also point to a need for the psychoeducational materials
to be available in a number of different languages. Training in ethnicity
awareness issues should be made more widely available for community mental
health professionals who are attempting to deliver CBT.
Critical appraisal
This study population is not representative of all patients with
schizophrenia but is representative of those patients who are on the
case-loads of community mental health team members. There was no difference
between the groups at baseline in terms of general characteristics, medication
dose or type, or severity of illness as indicated by number of visits or days
in hospital. It is clear, therefore, that medication and illness severity are
ruled out as confounding factors, which might explain the study results.
Similarly, there was no difference in these parameters over the study period.
However, the differential drop-out rate between the groups may have influenced
these results. It is important to remember that the TAU comparison group does
not control for the non-specific effects of the nurse's contact time with the
patient. Although attempts were made to protect blinding, there remains the
possibility of compromised blinding of ratings due to inadvertent patient
disclosure of therapy material.
Implications for carers
Carers were well engaged also and implications for carers displayed high
levels of satisfaction with the CBT intervention. The high levels of
satisfaction expressed by carers highlight the importance of delivering
interventions in which carers feel involved and which do not lead to feelings
of alienation. Those patients treated with their carer did not do
significantly better than those treated alone. Burden of care was not shown to
be improved by the end of therapy, and this mirrors the findings of other
studies using this measure (Haddock et
al, 1994). However, it is encouraging that such a brief
intervention can, in an illness such as schizophrenia, produce a clinically
detectable improvement for the patient linked to high carer satisfaction.
Implications for training
Statistically significant improvements in insight occurred in the CBT
intervention group compared with the TAU group but importantly, this did not
in general lead to an increase in depression or suicidality. However, there
was a trend indicating that sudden increases in insight of greater than 25%
were to be avoided and needed to be contained within a therapeutic
relationship. This issue needs to be stressed further in psychosocial training
and risk assessment. It is of interest that the improvements seen did not
relate primarily to improvement in psychotic symptoms, but it may well be that
follow-up might reveal improvement through the mechanism of improved coping
and adherence due to insight improvement. To be able to deliver this
intervention, CPNs require 10 days of intensive training combined with weekly
supervision. If this was made available, CPNs would be able to deliver brief
viable interventions of proven benefit rather than delivering intensive case
management, which is known to add little to standard case management. The
study supports the general principle contained in the National Service
Framework for Mental Health
(Department of Health, 1999) of
increased training and implementation of high-quality psychosocial
interventions in schizophrenia.
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Clinical Implications and Limitations |
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LIMITATIONS
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ACKNOWLEDGMENTS |
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We also acknowledge the significant contribution of the Insight into Schizophrenia Advisory Board: Paul Farmer, Jimmy Glass, Richard Gray, Lisa Haywood, Professor Julian Leff, Nigel Maguire, Dr Diana Morrison, Professor David Cunningham Owens, Brian Rogers and Marjorie Wallace.
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Received for publication August 13, 2001. Revision received February 22, 2002. Accepted for publication February 25, 2002.
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