Clinical Trial: Efficacy and Mechanisms of Change of an Emotion-oriented Version of Cognitive-behavioral Therapy for Psychosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy and Mechanisms of Change of an Emotion-oriented Version of Cognitive-behavioral Therapy for Psychosis (CBTp-E) in Reducing Delusions. A Randomized-controlled Trea

Brief 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 Summary:

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
    Sponsor: Philipps University Marburg Medical Center

    Current Primary Outcome: Change in Psychotic Rating Scale (PSYRATS) delusions scale [ Time Frame: Change between pre-therapy and post-therapy assessment after six month ]

    Assessment of delusion frequency, delusion distress, conviction and loss of quality of life due to the delusion


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Change in Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Change between pre-therapy and post-therapy assessment after six month ]
      Assessment of positive, negative and general symptoms of schizophrenia
    • Change in Calgary Depression Rating Scale for Schizophrenia (CDSS( [ Time Frame: Change between pre-therapy and post-therapy assessment after six month ]
      Assessment of depressive symptoms in patients with schizophrenia
    • Change in Role Functioning Scale (RFS) [ Time Frame: Change between pre-therapy and post-therapy assessment after six month ]
      Assessment of social functioning
    • Change in Peters et al. Delusions Inventory (PDI- R) [ Time Frame: Change between pre-therapy and post-therapy assessment after six month ]
      Assessment of self-rated delusion frequency, conviction and distress.


    Original Secondary Outcome: Same as current

    Information By: Philipps University Marburg Medical Center

    Dates:
    Date Received: February 26, 2016
    Date Started: May 2016
    Date Completion: May 2021
    Last Updated: November 24, 2016
    Last Verified: November 2016