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

Study Overview
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Brief Summary
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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
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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: 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. 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. 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.

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

Conditions
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Sleep, Schizophrenia, Psychotic Disorders, Delusions, Emotions, Self-esteem

Intervention / Treatment
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* Behavioral: emotion-oriented Cognitive Behavior Therapy


Participation Criteria
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Eligibility Criteria
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Treatment Group: Inclusion Criteria: Diagnosis of schizophrenia, schizoaffective disorder, delusional disorder (DSM-5 diagnosis) Delusions present in the last three months (score of at least three in three out of six PSYRATS scores) problems in at least two out of three possible mediators: sleep problems (ISI sum score > 7), low self-esteem (score > 3in the BCSS negative self scale) and/or problems in emotion regulation (score in all items < 4) fluent in German language agree to participate estimated general intelligence of at least 70 in the German Mehrfachwahlwortschatztest (MWT-B) no present suicidality Exclusion Criteria: acute suicidal tendency comorbid diagnosis of borderline personality disorder and/or substance use disorder in the last six month taking of Benzodiazepines

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBTd-E<br>Experimental: emotion-oriented Cognitive Behavior Therapy focused on delusions for patients with schizophrenia-spectrum disorders and delusions. The therapeutical intervention follows a treatment-manual consisting of two modules. Patients work on two modules every week for 25 weeks in a row. Module I comprises psychoeducation on emotions, training radical acceptance of emotions and mindfulness, cognitive and behavioral strategies in order to change negative emotions and in order to foster positive emotions and suggestions for life-style changes (positive activities, sports, stress reduction). In the second module, the focus 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. | Behavioral: emotion-oriented Cognitive Behavior Therapy<br>* 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.<br>* Other names: CBTd-E;|
| Placebo Comparator: Treatment as Usual<br>Patients who are randomized and assigned to the Wait-list receive treatment as usual (regular visits to a physicist every third month and antipsychotic medication). After six month the waiting list patients receive the treatment specified above. | Behavioral: emotion-oriented Cognitive Behavior Therapy<br>* 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.<br>* Other names: CBTd-E;|

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 due to the delusion | Change between pre-therapy and post-therapy assessment after six month | 

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 pre-therapy and post-therapy assessment after six month | 
| Change in Calgary Depression Rating Scale for Schizophrenia (CDSS( | Assessment of depressive symptoms in patients with schizophrenia | Change between pre-therapy and post-therapy assessment after six month | 
| Change in Role Functioning Scale (RFS) | Assessment of social functioning | Change between pre-therapy and post-therapy assessment after six month | 
| Change in Peters et al. Delusions Inventory (PDI- R) | Assessment of self-rated delusion frequency, conviction and distress. | Change between pre-therapy and post-therapy assessment after six month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delusions, Schizophrenia, Cognitive Behavior Therapy, Emotion, Emotion regulation, self-esteem, sleep quality, Efficacy of change