Pilot-trial of Emotion-focused Cognitive Behavior Therapy for Patients With Schizophrenia (CBT-E)

Comparison of Emotion-focused Cognitive Behavior Therapy for Patients With Schizophrenia With Standard Treatment: Effects on Psychological Parameters and Rehospitalisation

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Delusional Disorder; Brief Psychotic Disorder
• Intervention / Treatment: Behavioral: CBT-E; Behavioral: Treatment as Usual

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20146
    • University of Hamburg, Faculty of Clinical Psychology and Psychotherapy
  • Hessen
    • Marburg, Hessen, Germany, 35037
      • University of Marburg, Faculty of Clinical Psychology and Psychotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: Emotion-focused Cognitive Behavior Therapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: March 3, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): June 1, 2016

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Schizophrenia; self-esteem; Cognitive Behavior Therapy; emotion regulation; psychotic disorders; randomized-controlled trial
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders; Schizophrenia, Paranoid
• Other Study ID Numbers: CBT-E_MehlLincoln

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED