The aim of the present single-blind randomized-controlled therapy study is to assess the efficacy of a new form of Cognitive Behavioral Therapy for delusions with a focus on emotion regulation, improvement of self-esteem and sleep quality (CBTd-E).
Numerous meta-analyses have found Cognitive Behaviour Therapy for psychosis (CBTp) to be effective. The effect sizes that are achieved for positive symptoms in addition to antipsychotic treatment vary between small to medium. However, the effect sizes for changes in delusions are somewhat lower. Thus, it could prove beneficial to tailor CBTp interventions more precisely to the processes that are relevant to delusions. Empirically derived models of the formation and maintenance of delusions postulate an important role of cognitive biases, emotional factors and self-esteem. Additional studies have demonstrated the relevance of impaired sleep to delusions. Nevertheless, CBTp interventions that aim to change delusions tend to focus mainly on reasoning bias. The results of several uncontrolled pilot studies that focused primarily at improving emotional factors, quality of sleep and self-esteem in patients with delusions indicate that changes in these factors have the potential to reduce delusions. However, in these studies the singular interventions were short and were not implemented into a broader therapy rational. It can thus be assumed that a combination of CBT-interventions within a broader therapy rational might have an even greater impact on delusions. The aim of the present single-blind randomized-controlled therapy study is to assess the efficacy of a new form of Cognitive Behavioral Therapy for delusions with a focus on emotion regulation, improvement of self-esteem and sleep quality (CBTd-E) that will be applied in 25 individual sessions. Moreover, the study aims to test whether the efficacy of CBTd-E is mediated by the postulated processes. The main hypotheses are: 1. Baseline differences: in comparison to healthy controls, patients with schizophrenia show more pronounced problems in emotion regulation, a reduced sleep quality and a lower and less stable self-esteem. 2. Efficacy of CBTd-E: patients with acute delusions who receive CBTd-E show a more pronounced reduction of delusions (primary outcome), as well as a more pronounced reduction of positive symptoms, depression and general psychopathology, a stronger improvement in general and social functioning and will receive lower doses of antipsychotic medication (secondary outcomes) at post-treatment. 3. Mediation: the effect of CBTd-E on change in delusions is mediated by a) improved emotional stability and ability to regulate one's own emotions, b) improved sleep quality, c) improved and more stable self-esteem. In addition to questionnaires and interviews, behavioral paradigms, psychophysiological assessments and electronic diaries will be used to test the hypotheses. If we can demonstrate that CBTd-E reduces delusions, this would provide us with a more acceptable and feasible therapy for treating delusions.
Emotion-oriented Cognitive Behavior Therapy with a focus on delusions: Aim of the intervention is to change factors that are involved in the formation and maintenance of delusions: emotional stability and regulation of negative emotions, sleep quality and self-esteem.
University of Marburg, Faculty of Clinical Psychology and Psychotherapy
Marburg, Hesse, Germany
University of Hamburg, Faculty of Clinical Psychology and Psychotherapy
Hamburg, Germany
Change in Psychotic Rating Scale (PSYRATS) delusions scale
Assessment of delusion frequency, delusion distress, conviction and loss of quality of life due to the delusion
Time frame: Change between pre-therapy and post-therapy assessment after six month
Change in Positive and Negative Syndrome Scale (PANSS)
Assessment of positive, negative and general symptoms of schizophrenia
Time frame: Change between pre-therapy and post-therapy assessment after six month
Change in Calgary Depression Rating Scale for Schizophrenia (CDSS(
Assessment of depressive symptoms in patients with schizophrenia
Time frame: Change between pre-therapy and post-therapy assessment after six month
Change in Role Functioning Scale (RFS)
Assessment of social functioning
Time frame: Change between pre-therapy and post-therapy assessment after six month
Change in Peters et al. Delusions Inventory (PDI- R)
Assessment of self-rated delusion frequency, conviction and distress.
Time frame: Change between pre-therapy and post-therapy assessment after six month
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
94