Clinical Trial: Pilot-trial of Emotion-focused Cognitive Behavior Therapy for Patients With Schizophrenia

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Comparison of Emotion-focused Cognitive Behavior Therapy for Patients With Schizophrenia With Standard Treatment: Effects on Psychological Parameters and Rehospitalisation

Brief Summary: The present study is a pilot single-blind randomized controlled therapy study. Its aim is to assess the efficacy of an emotion-focussed form of Cognitive behavior Therapy that focusses on emotional processes that are involved in the formation and maintenance of delusions such as emotional stability, emotion regulation and self-esteem.

Detailed Summary:

Cognitive Behavior Therapy for psychosis (CBTp) is an effective treatment for patients with psychosis. Several meta-analyses showed an effect of CBTp in addition to antipsychotic treatment of small to medium effect size with regard to positive symptoms, general psychopathology and depression. Nevertheless, present research suggests that are especially emotional processes are closely related to positive symptoms and delusions, such as negative emotions, low self-esteem, depression and anxiety, whereas present interventions of CBTp focus often especially on cognitive interventions in order to change delusions as well as more cognitive risk factors for delusions such as reasoning biases and a dysfunctional causal attribution style.

Thus, the aim of the present single-blind randomized-controlled pilot therapy study was to assess the efficacy of a new form of emotion-focussed Cognitive behavior therapy for psychosis with regard to change in positive symptoms and delusions in comparison to standard treatment.

The main hypotheses are:

- Efficacy of CBT-E: patients with schizophrenia who receive CBT-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.

Sponsor: Philipps University Marburg Medical Center

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: Philipps University Marburg Medical Center

Dates:
Date Received: March 3, 2016
Date Started: January 2014
Date Completion: September 2019
Last Updated: November 24, 2016
Last Verified: November 2016