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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Schizophrenia, Delusional Disorder, Schizoaffective Disorder, Brief Psychotic Disorder, Schizophreniform Disorder

Intervention / Treatment
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* Behavioral: CBT-E
* Behavioral: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The CBT-E group receives 15-25 sessions of cognitive behavior therapy with a special focus on emotion regulation (CBT-E), the wait list group receives CBT-E after six month waiting time
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT-E<br>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. | Behavioral: CBT-E<br>* Patients receive 25 sessions of individual emotion-focused Cognitive Behavior Therapy based on a manual. Interventions aim on patients' mood by implementing positive activities in their daily routine. Further, patients train to reduce worrying behavior. Social contacts are fostered as well. Later, patients are informed on emotions and train emotion regulation strategies. Finally, the focus of CBT-E is on self-acceptance.Patients receive psychoeducation on self-acceptance and learn strategies in order to reduce negative self-schema and foster positive self-schema.<br>* Other names: Emotion-focused Cognitive Behavior Therapy;|
| Placebo Comparator: Treatment as Usual<br>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. | Behavioral: Treatment as Usual<br>* Patients receive standardized treatment. After a waiting period of six month, patients receive CBT-E<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, psychotic disorders, Cognitive Behavior Therapy, emotion regulation, self-esteem, randomized-controlled trial