Adverse Effects of Cognitive Behavioral Therapy and Cognitive Remediation in Schizophrenia: Results of the Treatment of Negative Symptoms Study
The Journal of Nervous and Mental Disease, 07/06/2012
Klingberg S et al. – The severe adverse event rate was comparable between both interventions and was relatively low, given the severity of the psychotic disorder. Therapists should be aware of a subgroup of patients who show symptom increases with large effect sizes and might require more intensive care.Methods
- In a randomized clinical trial, the authors investigated the efficacy of CBT for the reduction of negative symptoms as compared with cognitive remediation (CR) in schizophrenia patients (n = 198).
- Safety was addressed through assessment of severe adverse events (SAEs), which were defined as suicides, suicide attempts, suicidal crises, and severe symptom exacerbations over a period of 12 months after inclusion in the study.
- Monthly assessments with Positive and Negative Syndrome Scale and Scale for the Assessment of Negative Symptoms allowed for the analysis of symptom increases during the treatment.
- There were no suicides in the trial.
- SAEs were observed in 10 CBT and 5 CR patients.
- Increases in negative symptoms occurred in 64 CBT and 58 CR patients.
- These differences were not significant.
- The maximum increase in negative symptoms under treatment, as compared with the baseline, was equal to an effect size of –0.66 in CBT patients and –0.77 in CR patients.