Pilot-trial of Emotion-focused Cognitive Behavior Therapy for Patients With Schizophrenia

NCT ID: NCT02787122

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2017-12-31

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.

Conditions

Schizophrenia; Delusional Disorder; Schizoaffective Disorder; Brief Psychotic Disorder; Schizophreniform Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

CBT-E

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Treatment as Usual

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Emotion-focused Cognitive Behavior Therapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hamburg-Eppendorf

OTHER

Sponsor Role: collaborator

Philipps University Marburg

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Stephanie Mehl

Prof. Dr. rer. nat.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie Mehl, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Philipps University Marburg

Tania M. Lincoln

Role: PRINCIPAL_INVESTIGATOR

University of Hamburg-Eppendorf

Winfried Rief

Role: STUDY_DIRECTOR

Philipps University Marburg

Tilo Kircher

Role: STUDY_DIRECTOR

Philipps University Marburg

Locations

University of Marburg, Faculty of Clinical Psychology and Psychotherapy

Marburg, Hesse, Germany

University of Hamburg, Faculty of Clinical Psychology and Psychotherapy

Hamburg, , Germany

Countries

Germany

Other Identifiers

CBT-E_MehlLincoln

Identifier Type: -

Identifier Source: org_study_id