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NCT Number: NCT02787122

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

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.

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Key information

Conditions

Schizophrenia Behavior Brief Psychotic Disorder Delusional Disorder Emotional Regulation Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Paranoid Schizophreniform Disorder Self-Control Social Behavior

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Marburg, Faculty of Clinical Psychology and Psychotherapy, Marburg, Hesse, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT-E

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.

Other names: Emotion-focused Cognitive Behavior Therapy

Treatment as Usual

Behavioral

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Collaborators

  • University of Hamburg-Eppendorf

Registry information

Official study title

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

Acronym: CBT-E

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 1, 2016
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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