Efficacy and Mechanisms of Change of an Emotion-oriented Version of Cognitive-behavioral Therapy for Psychosis
Condition: Schizophrenia; Psychotic Disorders; Delusions; Emotions; Self-esteem; Sleep
MeSH terms: Schizophrenia; Psychotic Disorders; Delusions
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): emotion-oriented Cognitive Behavior Therapy
Intervention type(s): Behavioral
Intervention description(s): 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.
Other intervention name(s): CBTd-E
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Delusions; Schizophrenia; Cognitive Behavior Therapy; Emotion; Emotion regulation; self-esteem; sleep quality; Efficacy of change