A Preliminary Controlled Trial of Cognitive Behavioral Therapy in Clozapine-Resistant Schizophrenia

Barretto, Eliza Martha de Paiva; Kayo, Monica; Avrichir, Belquiz Schifnagel; Reis, António; Camargo, Maria das Graças Miquelutti; Napolitano, Isabel Cristina; Nery, Fabiano G.; Pinto, Jony Arrais; Bannwart, Silvia; Scemes, Silvia; Sarno, Elaine Di; Elkis, Hélio

doi:10.1097/nmd.0b013e3181be7422

Cited by 50 publications

(39 citation statements)

References 22 publications

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“…For baseline comparisons between groups, the Mann-Whitney Test was used for the continuous variables, and the Chi-squared test was used for the categorical variables. For cognitive performance comparisons between the experimental and control groups at different moments (baseline and after intervention), a nonparametric analysis of repeated measures [ 49 – 52 ] was used. This method tests the hypotheses of the existence of an effect either between groups (CT and control) or within groups (repetitions-changes over time), as well as the interaction between these factors (groups and changes over time).…”

Section: Methodsmentioning

confidence: 99%

Cognitive Training for Schizophrenia in Developing Countries: A Pilot Trial in Brazil

Pontes

Martins

Napolitano

et al. 2013

Schizophrenia Research and Treatment

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Cognitive deficits in schizophrenia can massively impact functionality and quality of life, furthering the importance of cognitive training. Despite the development of the field in Europe and in the United States, no programmes have been developed and tested in developing countries. Different cultural backgrounds, budget restrictions, and other difficulties may render treatment packages created in high income countries difficult for adoption by developing nations. We performed a pilot double-blind, randomized, controlled trial in order to investigate the efficacy and feasibility of an attention and memory training programme specially created in a developing nation. The intervention used simple, widely available materials, required minimal infrastructure, and was conducted in groups. The sample included seventeen stable Brazilians with schizophrenia. Sessions were conducted weekly during five months. The cognitive training group showed significant improvements in inhibitory control and set-shifting over time. Both groups showed improvements in symptoms, processing speed, selective attention, executive function, and long-term visual memory. Improvements were found in the control group in long-term verbal memory and concentration. Our findings reinforce the idea that cognitive training in schizophrenia can be constructed using simple resources and infrastructure, facilitating its adoption by developing countries, and it may improve cognition.

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Section: Methodsmentioning

confidence: 99%

Cognitive Training for Schizophrenia in Developing Countries: A Pilot Trial in Brazil

Pontes

Martins

Napolitano

et al. 2013

Schizophrenia Research and Treatment

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“…However, an effect was not found for the reduction of positive symptoms. Although the result of the study by Barretto et al 84 is encouraging, there are significant methodological limitations. The sample size was very small, limiting the power of the study to detect an effect of CBT for positive symptoms.…”

Section: Cognitive-behavioural Therapy For Clozapine-resistant Schizomentioning

confidence: 96%

“…To date, only one study has examined the efficacy of CBT for CRS. 84 In this controlled trial, treatment resistance was evaluated using Kane et al's 44 criteria and, to meet trial inclusion criteria, participants were required to have taken clozapine for ≥ 6 months without improvement of symptoms of psychosis. Twenty-two participants who met the inclusion criteria were allocated to either CBT (n = 10) or befriending (n = 12).…”

Section: Cognitive-behavioural Therapy For Clozapine-resistant Schizomentioning

confidence: 99%

Cognitive–behavioural therapy for clozapine-resistant schizophrenia: the FOCUS RCT

Morrison

Pyle

Gumley

et al. 2019

Health Technol Assess

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BackgroundClozapine (clozaril, Mylan Products Ltd) is a first-choice treatment for people with schizophrenia who have a poor response to standard antipsychotic medication. However, a significant number of patients who trial clozapine have an inadequate response and experience persistent symptoms, called clozapine-resistant schizophrenia (CRS). There is little evidence regarding the clinical effectiveness of pharmacological or psychological interventions for this population.ObjectivesTo evaluate the clinical effectiveness and cost-effectiveness of cognitive–behavioural therapy (CBT) for people with CRS and to identify factors predicting outcome.DesignThe Focusing on Clozapine Unresponsive Symptoms (FOCUS) trial was a parallel-group, randomised, outcome-blinded evaluation trial. Randomisation was undertaken using permuted blocks of random size via a web-based platform. Data were analysed on an intention-to-treat (ITT) basis, using random-effects regression adjusted for site, age, sex and baseline symptoms. Cost-effectiveness analyses were carried out to determine whether or not CBT was associated with a greater number of quality-adjusted life-years (QALYs) and higher costs than treatment as usual (TAU).SettingSecondary care mental health services in five cities in the UK.ParticipantsPeople with CRS aged ≥ 16 years, with anInternational Classification of Diseases, Tenth Revision (ICD-10) schizophrenia spectrum diagnoses and who are experiencing psychotic symptoms.InterventionsIndividual CBT included up to 30 hours of therapy delivered over 9 months. The comparator was TAU, which included care co-ordination from secondary care mental health services.Main outcome measuresThe primary outcome was the Positive and Negative Syndrome Scale (PANSS) total score at 21 months and the primary secondary outcome was PANSS total score at the end of treatment (9 months post randomisation). The health benefit measure for the economic evaluation was the QALY, estimated from the EuroQol-5 Dimensions, five-level version (EQ-5D-5L), health status measure. Service use was measured to estimate costs.ResultsParticipants were allocated to CBT (n = 242) or TAU (n = 245). There was no significant difference between groups on the prespecified primary outcome [PANSS total score at 21 months was 0.89 points lower in the CBT arm than in the TAU arm, 95% confidence interval (CI) –3.32 to 1.55 points;p = 0.475], although PANSS total score at the end of treatment (9 months) was significantly lower in the CBT arm (–2.40 points, 95% CI –4.79 to –0.02 points;p = 0.049). CBT was associated with a net cost of £5378 (95% CI –£13,010 to £23,766) and a net QALY gain of 0.052 (95% CI 0.003 to 0.103 QALYs) compared with TAU. The cost-effectiveness acceptability analysis indicated a low likelihood that CBT was cost-effective, in the primary and sensitivity analyses (probability < 50%). In the CBT arm, 107 participants reported at least one adverse event (AE), whereas 104 participants in the TAU arm reported at least one AE (odds ratio 1.09, 95% CI 0.81 to 1.46;p = 0.58).ConclusionsCognitive–behavioural therapy for CRS was not superior to TAU on the primary outcome of total PANSS symptoms at 21 months, but was superior on total PANSS symptoms at 9 months (end of treatment). CBT was not found to be cost-effective in comparison with TAU. There was no suggestion that the addition of CBT to TAU caused adverse effects. Future work could investigate whether or not specific therapeutic techniques of CBT have value for some CRS individuals, how to identify those who may benefit and how to ensure that effects on symptoms can be sustained.Trial registrationCurrent Controlled Trials ISRCTN99672552.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 23, No. 7. See the NIHR Journals Library website for further project information.

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“…Barretto et al compared CBT for psychosis (n = 12) to nonspecific social support also termed “befriending” (BF, n = 9) over 20 individualized therapy sessions over 3 weeks and at 6 months 96. The clozapine dose remained the same for all participants throughout the trial and the rater was blinded for the participants’ intervention.…”

Section: Options For Clozapine-intolerant or Clozapine-resistant Peoplementioning

confidence: 99%

Pharmacotherapy for treatment-resistant schizophrenia

McIlwain¹,

Harrison²,

Wheeler³

et al. 2011

NDT

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Schizophrenia is a disabling mental illness with a lifetime prevalence of 0.7% worldwide and significant, often devastating, consequences on social and occupational functioning. A range of antipsychotic medications are available; however, suboptimal therapeutic response in terms of psychotic symptoms is common and affects up to one-third of people with schizophrenia. Negative symptoms are generally less amenable to treatment. Because of the consequences of inadequate symptom control, effective treatment strategies are required for people with treatment-resistant schizophrenia. Clozapine has been shown to be more effective than other antipsychotics in treatment-resistant populations in several studies; however, the occurrence of adverse effects, some of which are potentially life-threatening, are important limitations. In addition to those who are intolerant to clozapine, only 30% to 50% experience clinically significant symptom improvement. This review describes the recent evidence for treatment strategies for people not responding to nonclozapine antipsychotic agents and people not responding or only partially responding to clozapine.

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A Preliminary Controlled Trial of Cognitive Behavioral Therapy in Clozapine-Resistant Schizophrenia

Cited by 50 publications

References 22 publications

Cognitive Training for Schizophrenia in Developing Countries: A Pilot Trial in Brazil

Cognitive Training for Schizophrenia in Developing Countries: A Pilot Trial in Brazil

Cognitive–behavioural therapy for clozapine-resistant schizophrenia: the FOCUS RCT

Pharmacotherapy for treatment-resistant schizophrenia

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