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

Not Applicable

Completed

• Conditions: Schizophrenia; Schizophreniform Disorder; Delusional Disorder; Brief Psychotic Disorder; Schizoaffective Disorder
• Interventions: Behavioral: CBT-E; Behavioral: Treatment as Usual

• Registration Number: NCT02787122
• Lead Sponsor: Philipps University Marburg Medical Center

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 Description

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.

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-06-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Diagnosis of schizophrenia, schizoaffective disorder, delusional disorder or brief psychotic disorder
• Positive and Negative Syndrome Scale score in item P1 (delusions) of at least two
• fluent in German language
• agree to participate
• estimated general intelligence of at least 70 (assessed with the German Wortschatztest (MWT-B)
• no present suicidality

Exclusion Criteria

• acute suicidality
• comorbid diagnosis of borderline personality disorder and/or substance use disorder in the last six month
• intake of Benzodiazepines

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT-E	CBT-E	Emotion-focussed Cognitive behavior therapy: Patients receive 25 sessions of individual emotion-focused Cognitive Behavior Therapy. Interventions are behavioral activation, training of emotion regulation strategies, improvement of self-esteem and relapse prevention.
Treatment as Usual	Treatment as Usual	Patients who are randomized and assigned to the Wait list are required to wait for half a year, while they receive standardized care (antipsychotic medication). After half a year, they receive CBT-E, as well.

Primary Outcome Measures

Name	Time	Method
Change in Psychotic Rating Scale (PSYRATS) delusions scale	Change between assessment pre-therapy and assessment after six month of therapy	Assessment of delusion frequency, delusion distress, conviction and loss of quality of life

Secondary Outcome Measures

Name	Time	Method
Change in Calgary Depression Rating Scale for Schizophrenia (CDSS)	Change between assessment pre-therapy and assessment after six month of therapy	Assessment of depressive symptoms in patients with schizophrenia
Change in Paranoia Checklist (PCL)	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	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	Change between assessment pre-therapy and assessment after six month of therapy	Assessment of self-rated delusion frequency, delusional distress and delusional
Change in Positive and Negative Syndrome Scale (PANSS)	Change between assessment pre-therapy and assessment after six month of therapy	Assessment of positive, negative and general symptoms of schizophrenia
Change in Role Functioning Scale (RFS)	Change between assessment pre-therapy and assessment after six month of therapy	Assessment of social functioning

Trial Locations

Locations (2)

University of Hamburg, Faculty of Clinical Psychology and Psychotherapy; 🇩🇪 Hamburg, Germany

University of Marburg, Faculty of Clinical Psychology and Psychotherapy; 🇩🇪 Marburg, Hessen, Germany