CBT-E: Pilot-trial of Emotion-focused Cognitive Behavior Therapy for Patients With Schizophrenia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Behavioral: CBT-E
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.
Other Names:
|
| Placebo Comparator: 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. |
Behavioral: Treatment as Usual
Patients receive standardized treatment. After a waiting period of six month, patients receive CBT-E
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 Role Functioning Scale (RFS) [Change between assessment pre-therapy and assessment after six month of therapy]
Assessment of social functioning
- 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
Other Outcome Measures
- Change in Reactions to paranoid thoughts Scale (REPT) [Change between assessment pre-therapy and assessment after six month of therapy]
Assessment of cognitive and emotional reactions on paranoid thoughts
- Change in Symptom Checklist 9 (SCL-9) [Change between assessment pre-therapy and assessment after six month of therapy]
Assessment of severity of self-reported symptoms of different mental disorders (depression, anxiety, phobia, obsessive-compulsive symptoms, etc.)
- Change in Satisfaction With Life Scale (SWLS) [Change between assessment pre-therapy and assessment after six month of therapy]
Assessment of life satisfaction
- Change in Pittsburg Sleep Quality Inventory (PSQI) [Change between assessment pre-therapy and assessment after six month of therapy]
Assessment of objective sleep quality and sleep problems
- Change in number of social contacts (SozE) [Change between assessment pre-therapy and assessment after six month of therapy]
Assessment of number of social contacts in the last week
- Change in Perseverative Thinking Questionnaire (PTQ) [Change between assessment pre-therapy and assessment after six month of therapy]
Assessment of self-reported perseverative thinking and worrying
- Change in Scale of Emotion Regulation Competencies (SEK-27) [Change between assessment pre-therapy and assessment after six month of therapy]
Assessment of self-reported habitual use of different emotion regulation strategies
- Change in Self-Compassion Scale (SCS) [Change between assessment pre-therapy and assessment after six month of therapy]
Assessment of self-reported self-compassion
- Change in Brief Core Schema Scale (BCSS) [Change between assessment pre-therapy and assessment after six month of therapy]
Assessment of positive and negative self-schemas and positive and negative schemas of other persons
Eligibility Criteria
Criteria
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
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agree to participate
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Marburg, Faculty of Clinical Psychology and Psychotherapy | Marburg | Hessen | Germany | 35037 |
| 2 | University of Hamburg, Faculty of Clinical Psychology and Psychotherapy | Hamburg | Germany | 20146 |
Sponsors and Collaborators
- Philipps University Marburg Medical Center
- University of Hamburg-Eppendorf
Investigators
- Principal Investigator: Stephanie Mehl, Ph. D., Philipps University Marburg Medical Center
- Principal Investigator: Tania M. Lincoln, University of Hamburg-Eppendorf
- Study Director: Winfried Rief, Philipps University Marburg Medical Center
- Study Director: Tilo Kircher, Philipps University Marburg Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CBT-E_MehlLincoln