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| Name | Class |
|---|---|
| University of Hamburg-Eppendorf | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-E | Active Comparator | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-E | Behavioral | 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. |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Reactions to paranoid thoughts Scale (REPT) | Assessment of cognitive and emotional reactions on paranoid thoughts | Change between assessment pre-therapy and assessment after six month of therapy |
| Change in Symptom Checklist 9 (SCL-9) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Mehl, Ph. D. | Philipps University Marburg | Principal Investigator |
| Tania M. Lincoln | University of Hamburg-Eppendorf | Principal Investigator |
| Winfried Rief | Philipps University Marburg | Study Director |
| Tilo Kircher | Philipps University Marburg | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Marburg, Faculty of Clinical Psychology and Psychotherapy | Marburg | Hesse | 35037 | Germany | ||
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D012563 | Schizophrenia, Paranoid |
| D011618 | Psychotic Disorders |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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
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Blinded rating of diagnostic interviews
|
|
| Treatment as Usual | Behavioral | Patients receive standardized treatment. After a waiting period of six month, patients receive CBT-E |
|
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 |
Assessment of severity of self-reported symptoms of different mental disorders (depression, anxiety, phobia, obsessive-compulsive symptoms, etc.)
| Change between assessment pre-therapy and assessment after six month of therapy |
| Change in Satisfaction With Life Scale (SWLS) | Assessment of life satisfaction | Change between assessment pre-therapy and assessment after six month of therapy |
| Change in Pittsburg Sleep Quality Inventory (PSQI) | Assessment of objective sleep quality and sleep problems | Change between assessment pre-therapy and assessment after six month of therapy |
| Change in number of social contacts (SozE) | Assessment of number of social contacts in the last week | Change between assessment pre-therapy and assessment after six month of therapy |
| Change in Perseverative Thinking Questionnaire (PTQ) | Assessment of self-reported perseverative thinking and worrying | Change between assessment pre-therapy and assessment after six month of therapy |
| Change in Scale of Emotion Regulation Competencies (SEK-27) | Assessment of self-reported habitual use of different emotion regulation strategies | Change between assessment pre-therapy and assessment after six month of therapy |
| Change in Self-Compassion Scale (SCS) | Assessment of self-reported self-compassion | Change between assessment pre-therapy and assessment after six month of therapy |
| Change in Brief Core Schema Scale (BCSS) | Assessment of positive and negative self-schemas and positive and negative schemas of other persons | Change between assessment pre-therapy and assessment after six month of therapy |
| University of Hamburg, Faculty of Clinical Psychology and Psychotherapy |
| Hamburg |
| 20146 |
| Germany |
| D001519 | Behavior |