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

NCT02787122 | Completed

• 1 other identifier: CBT-E_MehlLincoln
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Schizophrenia; psychotic disorders; Cognitive Behavior Therapy; emotion regulation; self-esteem; randomized-controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Positive and Negative Syndrome Scale (PANSS)

  Change between assessment pre-therapy and assessment after six month of therapy

• Change in Calgary Depression Rating Scale for Schizophrenia (CDSS)

  Change between assessment pre-therapy and assessment after six month of therapy

• Change in Role Functioning Scale (RFS)

  Change between assessment pre-therapy and assessment after six month of therapy

• Change in Paranoia Checklist (PCL)

  Change between assessment pre-therapy and assessment after six month of therapy

• Change in Beck Depression Inventory-II

  Change between assessment pre-therapy and assessment after six month of therapy

Other Outcomes (9)

• Change in Reactions to paranoid thoughts Scale (REPT)

  Change between assessment pre-therapy and assessment after six month of therapy

• Change in Symptom Checklist 9 (SCL-9)

  Change between assessment pre-therapy and assessment after six month of therapy

• Change in Satisfaction With Life Scale (SWLS)

  Change between assessment pre-therapy and assessment after six month of therapy

Study Arms (2)

CBT-E

ACTIVE COMPARATOR

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

Treatment as Usual

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Emotion-focused Cognitive Behavior Therapy

CBT-E

Treatment as Usual BEHAVIORAL

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

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• acute suicidality
• comorbid diagnosis of borderline personality disorder and/or substance use disorder in the last six month
• intake of Benzodiazepines

Sponsors & Collaborators

• Philipps University Marburg: lead
• University of Hamburg-Eppendorf: collaborator

Study Sites (2)

University of Marburg, Faculty of Clinical Psychology and Psychotherapy

Marburg, Hesse, 35037, Germany

Location

University of Hamburg, Faculty of Clinical Psychology and Psychotherapy

Hamburg, 20146, Germany

Location

MeSH Terms

Conditions

Schizophrenia; Schizophrenia, Paranoid; Psychotic Disorders; Emotional Regulation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Stephanie Mehl, Ph. D.

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

• Tania M. Lincoln

  University of Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Winfried Rief

  Philipps University Marburg

  STUDY DIRECTOR

• Tilo Kircher

  Philipps University Marburg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blinded rating of diagnostic interviews
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. rer. nat.

Model Details: 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

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: June 1, 2016
• Study Start: January 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

DE (2)