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

Primary Purpose

Schizophrenia, Delusional Disorder, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CBT-E
Treatment as Usual
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, psychotic disorders, Cognitive Behavior Therapy, emotion regulation, self-esteem, randomized-controlled trial

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Marburg, Faculty of Clinical Psychology and Psychotherapy
  • University of Hamburg, Faculty of Clinical Psychology and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CBT-E

Treatment as Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Psychotic Rating Scale (PSYRATS) delusions scale
Assessment of delusion frequency, delusion distress, conviction and loss of quality of life

Secondary Outcome Measures

Change in Positive and Negative Syndrome Scale (PANSS)
Assessment of positive, negative and general symptoms of schizophrenia
Change in Calgary Depression Rating Scale for Schizophrenia (CDSS)
Assessment of depressive symptoms in patients with schizophrenia
Change in Role Functioning Scale (RFS)
Assessment of social functioning
Change in Paranoia Checklist (PCL)
Assessment of self-reported paranoid delusion frequency, distress and conviction
Change in Beck Depression Inventory-II
Assessment of self-reported depressive symptoms
Change in Peters et al. Delusions Inventory
Assessment of self-rated delusion frequency, delusional distress and delusional

Full Information

First Posted
March 3, 2016
Last Updated
March 3, 2020
Sponsor
Philipps University Marburg Medical Center
Collaborators
University of Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT02787122
Brief Title
Pilot-trial of Emotion-focused Cognitive Behavior Therapy for Patients With Schizophrenia
Acronym
CBT-E
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center
Collaborators
University of Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Delusional Disorder, Schizoaffective Disorder, Brief Psychotic Disorder, Schizophreniform Disorder
Keywords
Schizophrenia, psychotic disorders, Cognitive Behavior Therapy, emotion regulation, self-esteem, randomized-controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Participant
Masking Description
Blinded rating of diagnostic interviews
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-E
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT-E
Other Intervention Name(s)
Emotion-focused Cognitive Behavior Therapy
Intervention Description
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
Intervention Name(s)
Treatment as Usual
Intervention Description
Patients receive standardized treatment. After a waiting period of six month, patients receive CBT-E
Primary Outcome Measure Information:
Title
Change in Psychotic Rating Scale (PSYRATS) delusions scale
Description
Assessment of delusion frequency, delusion distress, conviction and loss of quality of life
Time Frame
Change between assessment pre-therapy and assessment after six month of therapy
Secondary Outcome Measure Information:
Title
Change in Positive and Negative Syndrome Scale (PANSS)
Description
Assessment of positive, negative and general symptoms of schizophrenia
Time Frame
Change between assessment pre-therapy and assessment after six month of therapy
Title
Change in Calgary Depression Rating Scale for Schizophrenia (CDSS)
Description
Assessment of depressive symptoms in patients with schizophrenia
Time Frame
Change between assessment pre-therapy and assessment after six month of therapy
Title
Change in Role Functioning Scale (RFS)
Description
Assessment of social functioning
Time Frame
Change between assessment pre-therapy and assessment after six month of therapy
Title
Change in Paranoia Checklist (PCL)
Description
Assessment of self-reported paranoid delusion frequency, distress and conviction
Time Frame
Change between assessment pre-therapy and assessment after six month of therapy
Title
Change in Beck Depression Inventory-II
Description
Assessment of self-reported depressive symptoms
Time Frame
Change between assessment pre-therapy and assessment after six month of therapy
Title
Change in Peters et al. Delusions Inventory
Description
Assessment of self-rated delusion frequency, delusional distress and delusional
Time Frame
Change between assessment pre-therapy and assessment after six month of therapy
Other Pre-specified Outcome Measures:
Title
Change in Reactions to paranoid thoughts Scale (REPT)
Description
Assessment of cognitive and emotional reactions on paranoid thoughts
Time Frame
Change between assessment pre-therapy and assessment after six month of therapy
Title
Change in Symptom Checklist 9 (SCL-9)
Description
Assessment of severity of self-reported symptoms of different mental disorders (depression, anxiety, phobia, obsessive-compulsive symptoms, etc.)
Time Frame
Change between assessment pre-therapy and assessment after six month of therapy
Title
Change in Satisfaction With Life Scale (SWLS)
Description
Assessment of life satisfaction
Time Frame
Change between assessment pre-therapy and assessment after six month of therapy
Title
Change in Pittsburg Sleep Quality Inventory (PSQI)
Description
Assessment of objective sleep quality and sleep problems
Time Frame
Change between assessment pre-therapy and assessment after six month of therapy
Title
Change in number of social contacts (SozE)
Description
Assessment of number of social contacts in the last week
Time Frame
Change between assessment pre-therapy and assessment after six month of therapy
Title
Change in Perseverative Thinking Questionnaire (PTQ)
Description
Assessment of self-reported perseverative thinking and worrying
Time Frame
Change between assessment pre-therapy and assessment after six month of therapy
Title
Change in Scale of Emotion Regulation Competencies (SEK-27)
Description
Assessment of self-reported habitual use of different emotion regulation strategies
Time Frame
Change between assessment pre-therapy and assessment after six month of therapy
Title
Change in Self-Compassion Scale (SCS)
Description
Assessment of self-reported self-compassion
Time Frame
Change between assessment pre-therapy and assessment after six month of therapy
Title
Change in Brief Core Schema Scale (BCSS)
Description
Assessment of positive and negative self-schemas and positive and negative schemas of other persons
Time Frame
Change between assessment pre-therapy and assessment after six month of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Mehl, Ph. D.
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tania M. Lincoln
Organizational Affiliation
University of Hamburg-Eppendorf
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Winfried Rief
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tilo Kircher
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
University of Marburg, Faculty of Clinical Psychology and Psychotherapy
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35037
Country
Germany
Facility Name
University of Hamburg, Faculty of Clinical Psychology and Psychotherapy
City
Hamburg
ZIP/Postal Code
20146
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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