Department of Psychological Medicine, Institute of Psychiatry, London, UK and Department of Psychiatry and Neuropsychiatry, Maastricht University, The Netherlands
Parnassia Institute, The Hague and University of Groningen, The Netherlands
Academic Division of Clinical Psychology, School of Psychiatry and Behavioural Sciences, University of Manchester, UK
University of Groningen and Department of Psychotic Disorders, GGZ-Drenthe, Assen, The Netherlands
Correspondence: Lucia R.Valmaggia, Department of Psychological Medicine, PO 67, Institute of Psychiatry, De Crespigny Park, London SE5 SE5 8AF, UK.Tel/fax: +44(0)220 7848 0952; e-mail: L.Valmaggia{at}iop.kcl.ac.uk
Declaration of interest None. Funding detailed in Acknowledgements.
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ABSTRACT |
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Aims To investigate the effects of cognitivebehavioural therapy on in-patients with treatment-refractory psychotic symptoms.
Method Manualised therapy was compared with supportive counselling in a randomised controlled study. Both interventions were delivered by experienced psychologists over 16 sessions oftreatment. Therapy fidelity was assessed by two independent raters. Participants underwent masked assessment at baseline, after treatment and at 6 months follow-up. Main outcome measures were the Positive and Negative Syndrome Scale and the Psychotic Symptoms Rating Scale. The analysis was by intention to treat.
Results Participants receiving cognitive cognitivebehavioural therapy had improved with regard to auditory hallucinations and illness insight at the post-treatment assessment, but these findings were not maintained at follow-up.
Conclusions Cognitivebehavioural therapy showed modest short-term benefits over supportive counselling for treatment-refractory positive symptoms of schizophrenia.
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INTRODUCTION |
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METHOD |
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Sample
The Netherlands has a population of 16 million people, about 100 000 of
whom have schizophrenia. Hospital admission is needed for more than 11 000
patients each year (Schizofrenie Platform,
2000). Depending on the course of the disease, patients can be
discharged to receive home-based care, day care or assertive community
treatment. Patients can also choose a sheltered living facility or, if
severely affected, live in long-stay housing in the hospital grounds.
According to the DSMIV (American
Psychiatric Association, 1994), positive symptoms appear to
reflect an excess or distortion of normal functions and can be divided into
two dimensions: the psychotic dimension, including delusions and
hallucinations, and the disorganisation dimension, including disorganised
speech and behaviour (American Psychiatric
Association, 1994: pp. 274275). In this study we wanted to
focus on the psychotic dimension, and the aim of the study was to test the
efficacy of cognitivebehavioural therapy for an in-patient population.
The sample size of 72 patients (two groups of 36) was determined with an a
priori sample size calculation (=0.05; power 0.80; effect size
0.60). Participants were recruited from the in-patient population of the
participating institutes if they met the following inclusion criteria:
A confirmed resistance to psychopharmacological treatment was established according to the following conventional criteria: symptoms unresponsive to at least two different antipsychotic compounds including an atypical antipsychotic, taken for enough time and in an acceptable dosage, as advised in the prescription guidelines (Kane et al, 1988). To exclude patients experiencing predominantly symptoms from the disorganisation dimension, the following exclusion criteria were also applied:
The authors wanted to ensure that any changes in symptoms were due to the psychological intervention provided and not to a change in medication, therefore anti-psychotic medication remained unchanged during the experimental period. If a considerable change in antipsychotic medication was necessary, the patient was withdrawn from the study.
Interventions
Cognitivebehavioural therapy
A comprehensive treatment manual was written (by the first three authors)
and the participating therapists were trained in using this protocol. The
therapy begins with an engagement phase which stresses the development of a
collaborative relationship between therapist and patient; their mutual goal
becomes reducing the distress that accompanies delusional beliefs, instead of
each trying to convince the other that the belief is or is not true. This
approach reduces reactance and facilitates the challenging of the beliefs in
the next phase of therapy (Kingdon &
Turkington, 1994). In the second phase a shared case formulation
is drawn up, based on a detailed assessment of the problems experienced by the
patient. The aim is to establish a link between thoughts and emotions and
between thoughts and behaviour. Specific techniques are then used aiming at a
reduction of the symptoms and a reduction of the distress that accompanies the
symptoms. With auditory hallucinations the aim is to change the beliefs about
the origin, power and dangerousness of voices
(Chadwick & Birchwood,
1994). In delusions, the focus is on challenging the dysfunctional
beliefs and learning to make more balanced conclusions. In the last phase of
therapy, treatment gains are consolidated and attention is given to relapse
prevention strategies. Some adaptations have to be taken into account when
working with patients with chronic schizophrenia: to cope with the attention
and memory problems the pace of the session is slower, the therapist asks
frequently for feedback on what was just discussed and frequently summarises
relevant information. Many patients cannot concentrate for an hour, so a break
of 510 min is introduced halfway through the session, and relevant
information is written down for the patient to read between sessions.
Supportive counselling
The supportive counselling protocol was a conventional method previously
used in other studies (Tarrier et
al, 1998; Lewis et
al, 2002). The therapist shows non-critical acceptance,
warmth, genuineness and empathy. The following basic skills are applied:
listening (to hear both the content and the feelings behind the
patients message), reflecting, empathising and summarising. Patients
are asked about a subject they would like to talk about during the session.
However, in our study patients had spent long periods in hospital and often
found it hard to find a subject they wanted to discuss. If this was the case
the therapist could ask questions about current living circumstances, illness
and current problems, daily routine, social contacts, family, and personal
history. In addition, the therapist offered the patients psycho-education
about schizophrenia; however, most patients declined this offer on the basis
that they had received it in the past.
Outcome measures
To quantify the primary hypothesis the following main outcome measures of
positive symptoms were selected: the Positive and Negative Syndrome Scale and
the Psychotic Symptoms Rating Scale (PSYRATS;
Haddock et al, 1999).
The PANSS has three sub-scales, measuring positive symptoms, negative symptoms
and general psychopathology. The PSYRATS consists of two scales: the auditory
hallucination scale and the delusion scale. The 11 items of the auditory
hallucination scale assess different dimensions of auditory hallucinations
over the past week and can be clustered in three factors: a physical
characteristics factor (frequency, duration, location and loudness), an
emotional characteristics factor (amount and degree of negative content and of
distress) and a cognitive interpretation factor (disruption, belief about
origin and attribution of control). The delusion scale consists of six items
which can be clustered in two factors: a cognitive interpretation factor
(amount and duration of preoccupation, conviction and disruption) and an
emotional characteristics factor (amount and intensity of distress). The
psychometric properties of the PSYRATS have been researched, and both the
auditory hallucination scale and the delusion scale have excellent interrater
reliability and good validity (Haddock
et al, 1999). Relapse was defined as an increase of more
than 10 in the score on the positive symptom sub-scale of the PANSS with the
deterioration in symptoms lasting longer than 3 days.
Treatment fidelity
To ensure treatment fidelity, all therapists received training in the
standardised protocols that were used in the study. In the first year of the
trial therapists met once a month for supervision; later, the meetings were
held once every 6 weeks. M.v.d.G. was the main supervisor, and N.T. came to
The Netherlands every 6 months for an extra supervision meeting. Both
therapeutic conditions were recorded to control adherence to protocol. Two
audiotapes for each condition for each therapist were selected at random;
these tapes were scored independently by the first author and by another
therapist who was not involved in the research, using an adapted version of
the Cognitive Therapy Scale for Psychosis
(Haddock et al,
2001).
Statistical analysis
Results were analysed using the Statistical Package for the Social Sciences
(SPSS) version 10 (SPSS,
1999). Differences between the two conditions with regard to the
main hypothesis were calculated using analysis of covariance (ANCOVA),
baseline assessment results were used as covariates, and the condition was
used as fixed factor. Levenes test of equality was used to control
sphericity (equality of variances of the differences between the two treatment
conditions). A violation of sphericity means a loss of power and uncertain
test results (Field, 2000).
Analysis was by intention to treat. Post-therapy and follow-up missing data
were calculated using the missing value analysis option of SPSS, which
estimates missing values using multiple linear regression
(Hill, 1997). Effect sizes
were calculated using Cohens formula
(Cohen, 1988). Numbers needed
to treat were calculated regarding the variables used to represent the primary
hypothesis. Pearsons correlation was used to analyse the results of the
scoring of the tapes done to ensure treatment fidelity.
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RESULTS |
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The baseline demographic characteristics of the participants are summarised in Table 1. The participants were predominately adult men, the large majority were single and only one patient was in paid employment. On average patients had been experiencing psychotic symptoms for the previous 11 years and had been admitted to hospital five times in the past 9 years. Depending on the type of variable, independent t-tests or chi-squared tests were carried out to control for differences in demographical variables between the two conditions. No significant difference was found between the two groups. With regard to the baseline assessment, the two randomised groups largely overlapped. Independent t-tests showed that there was a significant difference between the two groups regarding factor 2 of the auditory hallucination scale, emotional characteristics (two-tailed P=0.044). The supportive counselling group reported more emotional distress related to the auditory hallucinations.
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Medication use
Participants had tried five different anti-psychotics on average (if the
same medication was taken twice, it was counted as one medication taken). All
patients had taken at least one atypical antipsychotic and more than
two-thirds of them (n=41) had taken clozapine
(Table 1). All patients were
taking antipsychotic medication during the trial, and the majority were on
atypical antipsychotic regimens. Nine patients were using a typical compound
during the trial because they had been given depot medication. The medication
regimens were kept stable during the study. Three patients experienced a
relapse and their medication had to be changed; these patients were considered
to have withdrawn from the study.
Treatment fidelity
A total of 40 tapes were scored. The mean score of the
cognitivebehavioural therapy tapes scored by the first rater was 48.8
(s.d.=4.3) and the mean score of the supportive counselling tapes was 15.6
(s.d.=2.3). The second raters mean scores were 53.7 (s.d.=3.7) and 15.4
(s.d.=1.5) respectively. A Pearsons correlation calculated between the
two raters was 0.990 (P<0.001), indicating that the therapies were
delivered according to protocol.
Outcome measures
Table 2 shows the baseline,
post-treatment and follow-up scores with regard to the primary hypothesis. At
the post-treatment assessment the score on the positive subscale of the PANSS
showed a non-significant effect of therapeutic condition
(F(1,57)=3.58, P=0.064). Cognitivebehavioural therapy
was more effective than supportive counselling on factor 1, physical
characteristics, of the auditory hallucination scale (F(1,57)=6.43,
P=0.014) and factor 3, cognitive interpretation
(F(1,57)=6.86, P=0.011), but had no significant influence on
factor 2, emotional characteristics. No significant effect of the therapeutic
condition was found regarding the delusion scale factor 1, cognitive
interpretation, and factor 2, emotional characteristics. In the follow-up
results no significant effect of therapeutic condition on the score of any of
the scales used to assess positive symptoms was found.
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At follow-up the results of the analysis of covariance showed no significant effect on any of the variables measured. The effect sizes confirm the findings of the analysis of covariance.
Numbers needed to treat
Using the same criteria as in a previous study
(Tarrier et al,
2000), numbers needed to treat were calculated on a 20% symptom
improvement for the positive sub-scale of the PANSS and for the factors of the
PSYRATS. Table 3 displays the
NNT and 95% confidence intervals at post-treatment and follow-up for the
intention-to-treat analysis. The lack of statistical significance of the
results is reflected in the confidence intervals of the NNTs. If the treatment
effect is not statistically significant at the 5% level, the 95% confidence
intervals include infinity (Altman,
1998).
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DISCUSSION |
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Limitations
The first limitation of the study is that the strict inclusion and
exclusion criteria led to a selective sample of patients. To be included in
the study, participants had to have tried at least two antipsychotic
compounds, including at least one atypical agent. Problems with recruitment
were mainly due to the inefficient application of medication protocols in some
of the institutes that participated in the study, which made it difficult to
find patients who met the strict inclusion criteria with regard to
drug-therapy resistance. A second limitation lies in the small sample size,
which led to a lack of statistical power. Because of this lack of power,
improvements that might have been significant with a large sample size were
not found with the available data (type 2 error). A third limitation could be
the loss of significant results at follow-up. A possible explanation for this
loss could be that the patients included in the study had serious cognitive
disabilities and that 16 sessions might not have been sufficient to produce
stable results. Mueser et al
(1997) identified five
characteristics of successful psychiatric interventions in chronic illness:
they are direct and behavioural; produce specific effects on related outcomes
and do not generalise to other domains; are long-term interventions; are
delivered in the patients environment; and combine skills training and
environmental support. Our intervention might have been too short;
furthermore, it did not involve the environment of the patients.
Psychotic symptoms
The between-group analyses showed that cognitivebehavioural therapy
was more effective than supportive counselling at the post-treatment
assessment in reducing the physical characteristics and cognitive
interpretation of auditory hallucinations. This indicates that the group
receiving cognitivebehavioural therapy experienced a reduction in the
frequency, duration, location and loudness of auditory hallucinations. The
disruption of life associated with auditory hallucinations, belief about the
origin of hallucinations and the attribution of control improved in this
intervention group. No difference was found with regard to the emotional
characteristics of auditory hallucinations. Contrary to previous results (e.g.
Sensky et al, 2000),
in our study the differences post-treatment with regard to auditory
hallucinations were not maintained at follow-up. No between-group difference
was found regarding delusions. A larger percentage of participants in the
cognitivebehavioural condition showed a 20% reduction in symptoms on
the positive sub-scale of the PANSS.
Numbers needed to treat
The research was conducted in a population with long-term illness that had
proved resistant to other treatments including clozapine. To appreciate the
relevance of the NNT found in this research, the reader might be interested in
knowing that clozapine is effective in 32% of cases (NNT=5, 95% CI 47)
in producing a clinical improvement
(Wahlbeck et al,
2002). Patients taking clozapine showed fewer relapses in the
short term (NNT=20, 95% CI 1738); no data are available for relapse
prevention in the long term. Previous randomised controlled trials of the
effect of cognitivebehavioural therapy on symptoms, when compared with
other psychological interventions, show an NNT of 5
(National Institute for Clinical
Excellence, 2003).
Clinical implications
The results of our trial showed that psychological treatment could induce a
change in psychotic symptoms in in-patients with chronic illness. Excluding
patients from psychological help on the grounds that they are too ill to
benefit from therapy is not justified by these findings.
Cognitivebehavioural therapy for psychotic symptoms should therefore be
available in inpatient facilities.
The therapists and assessors who participated in the study were therapists from standard mental health services, not specialised research staff. As a result, cognitivebehavioural therapy for psychosis is now widely used in the participating institutes. Based on the experience accumulated during the course of the trial, a comprehensive teaching tool kit was produced (Gaag et al, 2000). In the subsequent years there has been an increasing demand for training in the use of this tool kit, and some therapists involved in the research have become involved as trainers.
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Clinical Implications and Limitations |
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LIMITATIONS
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ACKNOWLEDGMENTS |
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Received for publication March 23, 2004. Revision received September 14, 2004. Accepted for publication September 30, 2004.