Efficacy and Mechanisms of Change of an Emotion-oriented Version of Cognitive-behavioral Therapy for Psychosis

NCT02787135 | Completed

• 1 other identifier: CBTd-E_MehlLincoln2016
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the present single-blind randomized-controlled therapy study is to assess the efficacy of a new form of Cognitive Behavioral Therapy for delusions with a focus on emotion regulation, improvement of self-esteem and sleep quality (CBTd-E).

Conditions

Schizophrenia; Psychotic Disorders; Delusions; Emotions; Self-esteem; Sleep

Keywords

Delusions; Schizophrenia; Cognitive Behavior Therapy; Emotion; Emotion regulation; self-esteem; sleep quality; Efficacy of change

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 due to the delusion

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

Secondary Outcomes (4)

• Change in Positive and Negative Syndrome Scale (PANSS)

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

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

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

• Change in Role Functioning Scale (RFS)

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

• Change in Peters et al. Delusions Inventory (PDI- R)

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

Other Outcomes (10)

• Change in Emotion-regulation Questionnaire (ERQ)

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

• Change in Emotion regulation inventory

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

• Change in Paranoia assessed with Electronical mobile assessment

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

Study Arms (2)

CBTd-E

ACTIVE COMPARATOR

Experimental: emotion-oriented Cognitive Behavior Therapy focused on delusions for patients with schizophrenia-spectrum disorders and delusions. The therapeutical intervention follows a treatment-manual consisting of two modules. Patients work on two modules every week for 25 weeks in a row. Module I comprises psychoeducation on emotions, training radical acceptance of emotions and mindfulness, cognitive and behavioral strategies in order to change negative emotions and in order to foster positive emotions and suggestions for life-style changes (positive activities, sports, stress reduction). In the second module, the focus 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.

Behavioral: emotion-oriented Cognitive Behavior Therapy

Treatment as Usual

PLACEBO COMPARATOR

Patients who are randomized and assigned to the Wait-list receive treatment as usual (regular visits to a physicist every third month and antipsychotic medication). After six month the waiting list patients receive the treatment specified above.

Behavioral: emotion-oriented Cognitive Behavior Therapy

Interventions

emotion-oriented Cognitive Behavior Therapy BEHAVIORAL

Emotion-oriented Cognitive Behavior Therapy with a focus on delusions: Aim of the intervention is to change factors that are involved in the formation and maintenance of delusions: emotional stability and regulation of negative emotions, sleep quality and self-esteem.

Also known as: CBTd-E

CBTd-E; Treatment as Usual

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of schizophrenia, schizoaffective disorder, delusional disorder (DSM-5 diagnosis)
• Delusions present in the last three months (score of at least three in three out of six PSYRATS scores)
• problems in at least two out of three possible mediators: sleep problems (ISI sum score \> 7), low self-esteem (score \> 3in the BCSS negative self scale) and/or problems in emotion regulation (score in all items \< 4)
• fluent in German language
• agree to participate
• estimated general intelligence of at least 70 in the German Mehrfachwahlwortschatztest (MWT-B)
• no present suicidality

You may not qualify if:

• acute suicidal tendency
• comorbid diagnosis of borderline personality disorder and/or substance use disorder in the last six month
• taking of Benzodiazepines

Sponsors & Collaborators

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

Related Publications (2)

• Kammerer MK, Mehl S, Ludwig L, Lincoln TM. Sleep and circadian rhythm disruption predict persecutory symptom severity in day-to-day life: A combined actigraphy and experience sampling study. J Abnorm Psychol. 2021 Jan;130(1):78-88. doi: 10.1037/abn0000645. Epub 2020 Nov 19.

  PMID: 33211503 DERIVED

• Ludwig L, Mehl S, Krkovic K, Lincoln TM. Effectiveness of emotion regulation in daily life in individuals with psychosis and nonclinical controls-An experience-sampling study. J Abnorm Psychol. 2020 May;129(4):408-421. doi: 10.1037/abn0000505. Epub 2020 Feb 27.

  PMID: 32105124 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Delusions; Emotional Regulation; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Self-Control; Social Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Stephanie Mehl, Ph. D.

  Philipps University Marburg

  STUDY CHAIR

• Tania M Lincoln, Ph. D.

  University of Hamburg-Eppendorf

  STUDY CHAIR

• Tobias Teismann, Ph. D.

  Ruhr University of Bochum

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: June 1, 2016
• Study Start: May 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 5, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)