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

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ClinicalTrials.gov Identifier: NCT02787122
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : March 4, 2020
Sponsor:
Collaborator:
University of Hamburg
Information provided by (Responsible Party):
Prof. Dr. Stephanie Mehl, Philipps University Marburg Medical Center

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Delusional Disorder Schizoaffective Disorder Brief Psychotic Disorder Schizophreniform Disorder Behavioral: CBT-E Behavioral: Treatment as Usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (Participant)
Masking Description: Blinded rating of diagnostic interviews
Primary Purpose: Treatment
Official Title: Comparison of Emotion-focused Cognitive Behavior Therapy for Patients With Schizophrenia With Standard Treatment: Effects on Psychological Parameters and Rehospitalisation
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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 Name: 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




Primary Outcome Measures :
  1. Change in Psychotic Rating Scale (PSYRATS) delusions scale [ Time Frame: Change between assessment pre-therapy and assessment after six month of therapy ]
    Assessment of delusion frequency, delusion distress, conviction and loss of quality of life


Secondary Outcome Measures :
  1. Change in Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Change between assessment pre-therapy and assessment after six month of therapy ]
    Assessment of positive, negative and general symptoms of schizophrenia

  2. Change in Calgary Depression Rating Scale for Schizophrenia (CDSS) [ Time Frame: Change between assessment pre-therapy and assessment after six month of therapy ]
    Assessment of depressive symptoms in patients with schizophrenia

  3. Change in Role Functioning Scale (RFS) [ Time Frame: Change between assessment pre-therapy and assessment after six month of therapy ]
    Assessment of social functioning

  4. Change in Paranoia Checklist (PCL) [ Time Frame: Change between assessment pre-therapy and assessment after six month of therapy ]
    Assessment of self-reported paranoid delusion frequency, distress and conviction

  5. Change in Beck Depression Inventory-II [ Time Frame: Change between assessment pre-therapy and assessment after six month of therapy ]
    Assessment of self-reported depressive symptoms

  6. Change in Peters et al. Delusions Inventory [ Time Frame: Change between assessment pre-therapy and assessment after six month of therapy ]
    Assessment of self-rated delusion frequency, delusional distress and delusional


Other Outcome Measures:
  1. Change in Reactions to paranoid thoughts Scale (REPT) [ Time Frame: Change between assessment pre-therapy and assessment after six month of therapy ]
    Assessment of cognitive and emotional reactions on paranoid thoughts

  2. Change in Symptom Checklist 9 (SCL-9) [ Time Frame: Change between assessment pre-therapy and assessment after six month of therapy ]
    Assessment of severity of self-reported symptoms of different mental disorders (depression, anxiety, phobia, obsessive-compulsive symptoms, etc.)

  3. Change in Satisfaction With Life Scale (SWLS) [ Time Frame: Change between assessment pre-therapy and assessment after six month of therapy ]
    Assessment of life satisfaction

  4. Change in Pittsburg Sleep Quality Inventory (PSQI) [ Time Frame: Change between assessment pre-therapy and assessment after six month of therapy ]
    Assessment of objective sleep quality and sleep problems

  5. Change in number of social contacts (SozE) [ Time Frame: Change between assessment pre-therapy and assessment after six month of therapy ]
    Assessment of number of social contacts in the last week

  6. Change in Perseverative Thinking Questionnaire (PTQ) [ Time Frame: Change between assessment pre-therapy and assessment after six month of therapy ]
    Assessment of self-reported perseverative thinking and worrying

  7. Change in Scale of Emotion Regulation Competencies (SEK-27) [ Time Frame: Change between assessment pre-therapy and assessment after six month of therapy ]
    Assessment of self-reported habitual use of different emotion regulation strategies

  8. Change in Self-Compassion Scale (SCS) [ Time Frame: Change between assessment pre-therapy and assessment after six month of therapy ]
    Assessment of self-reported self-compassion

  9. Change in Brief Core Schema Scale (BCSS) [ Time Frame: Change between assessment pre-therapy and assessment after six month of therapy ]
    Assessment of positive and negative self-schemas and positive and negative schemas of other persons



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787122


Locations
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Germany
University of Marburg, Faculty of Clinical Psychology and Psychotherapy
Marburg, Hessen, Germany, 35037
University of Hamburg, Faculty of Clinical Psychology and Psychotherapy
Hamburg, Germany, 20146
Sponsors and Collaborators
Philipps University Marburg Medical Center
University of Hamburg
Investigators
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Principal Investigator: Stephanie Mehl, Ph. D. Philipps University Marburg Medical Center
Principal Investigator: Tania M. Lincoln University of Hamburg
Study Director: Winfried Rief Philipps University Marburg Medical Center
Study Director: Tilo Kircher Philipps University Marburg Medical Center
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Responsible Party: Prof. Dr. Stephanie Mehl, Prof. Dr. rer. nat., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT02787122    
Other Study ID Numbers: CBT-E_MehlLincoln
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Prof. Dr. Stephanie Mehl, Philipps University Marburg Medical Center:
Schizophrenia
psychotic disorders
Cognitive Behavior Therapy
emotion regulation
self-esteem
randomized-controlled trial
Additional relevant MeSH terms:
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Disease
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia, Paranoid
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders