Clinical trial NCT02787122: Pilot-trial of Emotion-focused Cognitive Behavior Therapy for Patients With Schizophrenia
Official title: Comparison of Emotion-focused Cognitive Behavior Therapy for Patients With Schizophrenia With Standard Treatment: Effects on Psychological Parameters and Rehospitalisation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Delusional Disorder
Schizoaffective Disorder
Brief Psychotic Disorder
Schizophreniform Disorder
Keywords: Schizophrenia
psychotic disorders
Cognitive Behavior Therapy
emotion regulation
self-esteem
randomized-controlled trial
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: University of Hamburg-Eppendorf
First posted: 2016-06-01
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

Eligibility 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
* 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

Primary outcomes:
measure: Change in Psychotic Rating Scale (PSYRATS) delusions scale
timeFrame: Change between assessment pre-therapy and assessment after six month of therapy
Secondary outcomes:
measure: Change in Positive and Negative Syndrome Scale (PANSS)
timeFrame: Change between assessment pre-therapy and assessment after six month of therapy
measure: Change in Calgary Depression Rating Scale for Schizophrenia (CDSS)
timeFrame: Change between assessment pre-therapy and assessment after six month of therapy
measure: Change in Role Functioning Scale (RFS)
timeFrame: Change between assessment pre-therapy and assessment after six month of therapy
measure: Change in Paranoia Checklist (PCL)
timeFrame: Change between assessment pre-therapy and assessment after six month of therapy
measure: Change in Beck Depression Inventory-II
timeFrame: Change between assessment pre-therapy and assessment after six month of therapy
measure: Change in Peters et al. Delusions Inventory
timeFrame: Change between assessment pre-therapy and assessment after six month of therapy
Other outcomes:
measure: Change in Reactions to paranoid thoughts Scale (REPT)
timeFrame: Change between assessment pre-therapy and assessment after six month of therapy
measure: Change in Symptom Checklist 9 (SCL-9)
timeFrame: Change between assessment pre-therapy and assessment after six month of therapy
measure: Change in Satisfaction With Life Scale (SWLS)
timeFrame: Change between assessment pre-therapy and assessment after six month of therapy
measure: Change in Pittsburg Sleep Quality Inventory (PSQI)
timeFrame: Change between assessment pre-therapy and assessment after six month of therapy
measure: Change in number of social contacts (SozE)
timeFrame: Change between assessment pre-therapy and assessment after six month of therapy
measure: Change in Perseverative Thinking Questionnaire (PTQ)
timeFrame: Change between assessment pre-therapy and assessment after six month of therapy
measure: Change in Scale of Emotion Regulation Competencies (SEK-27)
timeFrame: Change between assessment pre-therapy and assessment after six month of therapy
measure: Change in Self-Compassion Scale (SCS)
timeFrame: Change between assessment pre-therapy and assessment after six month of therapy
measure: Change in Brief Core Schema Scale (BCSS)
timeFrame: Change between assessment pre-therapy and assessment after six month of therapy
Locations:
city: Marburg
country: Germany
facility: University of Marburg, Faculty of Clinical Psychology and Psychotherapy
state: Hessen
city: Hamburg
country: Germany
facility: University of Hamburg, Faculty of Clinical Psychology and Psychotherapy
Study officials:
affiliation: Philipps University Marburg
name: Stephanie Mehl, Ph. D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Hamburg-Eppendorf
name: Tania M. Lincoln
role: PRINCIPAL_INVESTIGATOR
affiliation: Philipps University Marburg
name: Winfried Rief
role: STUDY_DIRECTOR
affiliation: Philipps University Marburg
name: Tilo Kircher
role: STUDY_DIRECTOR
References: