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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02787122
Other study ID # CBT-E_MehlLincoln
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2014
Est. completion date December 31, 2017

Study information

Verified date March 2020
Source Philipps University Marburg Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

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.
Treatment as Usual
Patients receive standardized treatment. After a waiting period of six month, patients receive CBT-E

Locations

Country Name City State
Germany University of Hamburg, Faculty of Clinical Psychology and Psychotherapy Hamburg
Germany University of Marburg, Faculty of Clinical Psychology and Psychotherapy Marburg Hessen

Sponsors (2)

Lead Sponsor Collaborator
Philipps University Marburg Medical Center University of Hamburg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other Change in Symptom Checklist 9 (SCL-9) 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
Other Change in Satisfaction With Life Scale (SWLS) Assessment of life satisfaction Change between assessment pre-therapy and assessment after six month of therapy
Other 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
Other 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
Other 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
Other 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
Other Change in Self-Compassion Scale (SCS) Assessment of self-reported self-compassion Change between assessment pre-therapy and assessment after six month of therapy
Other 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
Primary 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
Secondary 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
Secondary Change in Calgary Depression Rating Scale for Schizophrenia (CDSS) Assessment of depressive symptoms in patients with schizophrenia Change between assessment pre-therapy and assessment after six month of therapy
Secondary Change in Role Functioning Scale (RFS) Assessment of social functioning Change between assessment pre-therapy and assessment after six month of therapy
Secondary 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
Secondary Change in Beck Depression Inventory-II Assessment of self-reported depressive symptoms Change between assessment pre-therapy and assessment after six month of therapy
Secondary 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
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