Comparison of Emotion-focused Cognitive Behavior Therapy for Patients With Schizophrenia With Standard Treatment: Effects on Psychological Parameters and Rehospitalisation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Philipps University Marburg
- Enrollment
- 64
- Locations
- 4
- Primary Endpoint
- Change in Psychotic Rating Scale (PSYRATS) delusions scale
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Blinded rating of diagnostic interviews
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in Psychotic Rating Scale (PSYRATS) delusions scale
Time Frame: 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 Outcomes
- Change in Calgary Depression Rating Scale for Schizophrenia (CDSS)(Change between assessment pre-therapy and assessment after six month of therapy)
- Change in Paranoia Checklist (PCL)(Change between assessment pre-therapy and assessment after six month of therapy)
- Change in Beck Depression Inventory-II(Change between assessment pre-therapy and assessment after six month of therapy)
- Change in Peters et al. Delusions Inventory(Change between assessment pre-therapy and assessment after six month of therapy)
- Change in Positive and Negative Syndrome Scale (PANSS)(Change between assessment pre-therapy and assessment after six month of therapy)
- Change in Role Functioning Scale (RFS)(Change between assessment pre-therapy and assessment after six month of therapy)
Investigators
Prof. Dr. Stephanie Mehl
Prof. Dr. rer. nat.
Philipps University Marburg