We read with great interest the report on the randomised controlled trial (RCT) comparing cognitive-behavioural therapy (CBT) with supportive counselling for refractory psychotic symptoms of treatment-resistant schizophrenia (Reference Valmaggia, Van Der Gaag and TarrierValmaggia et al, 2005). It has a very convincing design but a few points need further discussion.
The sample size was calculated a priori, but an adequate number of patients could not be recruited. The small sample size led to a lack of statistical power, a limitation mentioned by the authors. However, this applied only to one intervention, supportive counselling, whereas there was an adequate estimated sample in the CBT group. Out of 62 participants randomised, post-treatment assessment was possible for 50 and follow-up was completed by 42. Although sample attrition is understandable in this kind of study the withdrawal rate is relatively high. More people in the CBT group refused assessment post-treatment compared with those who received supportive counselling. The reason for this needs to be explained. Loss of data by the assessor, leading to exclusion from the intention-to-treat analysis was greater for the group who received supportive counselling; this group already had fewer participants and the loss of data might have influenced the result.
The treatment groups were not comparable at the beginning of the study for one illness variable. The supportive counselling group reported significantly more emotional distress related to auditory hallucinations. This is important because there was no difference between the groups post-treatment and at follow-up assessment. In addition, the changes in negative symptoms reportedly favoured supportive counselling.
Valmaggia et al stated that ‘a larger percentage of participants in the cognitive-behavioural condition showed a 20% reduction in symptoms on the positive sub-scale of the PANSS’ (Positive and Negative Syndrome Scale); however, comparative figures for both treatments and statistical significance would have illustrated this better.
Previous RCTs of the effect on symptoms of CBT compared with other psychological interventions showed a number needed to treat (NNT) of 5 (National Institute for Clinical Excellence, 2003). In the index study, the NNT was 3 but the confidence intervals were large in the two areas where a significant difference was measured for CBT.
Valmaggia et al stated that CBT for refractory psychotic symptoms of schizophrenia should be available in in-patient facilities. However, the evidence from their study is not unequivocal. Although the literature suggests benefits from psychological intervention in this group of patients, more robust evidence is still required to confidently recommend one particular type of therapy over others.
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