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Efficacy and Mechanisms of Change of an Emotion-oriented Version of Cognitive-behavioral Therapy for Psychosis (CBTd-E)

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ClinicalTrials.gov Identifier: NCT02787135
Recruitment Status : Recruiting
First Posted : June 1, 2016
Last Update Posted : November 28, 2016
Sponsor:
Collaborators:
University of Hamburg
Ruhr University of Bochum
Information provided by (Responsible Party):
Prof. Dr. Stephanie Mehl, Philipps University Marburg Medical Center

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).

Condition or disease Intervention/treatment Phase
Schizophrenia Psychotic Disorders Delusions Emotions Self-esteem Sleep Behavioral: emotion-oriented Cognitive Behavior Therapy Phase 2

Detailed Description:

Numerous meta-analyses have found Cognitive Behaviour Therapy for psychosis (CBTp) to be effective. The effect sizes that are achieved for positive symptoms in addition to antipsychotic treatment vary between small to medium. However, the effect sizes for changes in delusions are somewhat lower. Thus, it could prove beneficial to tailor CBTp interventions more precisely to the processes that are relevant to delusions. Empirically derived models of the formation and maintenance of delusions postulate an important role of cognitive biases, emotional factors and self-esteem. Additional studies have demonstrated the relevance of impaired sleep to delusions. Nevertheless, CBTp interventions that aim to change delusions tend to focus mainly on reasoning bias.

The results of several uncontrolled pilot studies that focused primarily at improving emotional factors, quality of sleep and self-esteem in patients with delusions indicate that changes in these factors have the potential to reduce delusions. However, in these studies the singular interventions were short and were not implemented into a broader therapy rational. It can thus be assumed that a combination of CBT-interventions within a broader therapy rational might have an even greater impact on delusions.

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) that will be applied in 25 individual sessions. Moreover, the study aims to test whether the efficacy of CBTd-E is mediated by the postulated processes. The main hypotheses are:

  1. Baseline differences: in comparison to healthy controls, patients with schizophrenia show more pronounced problems in emotion regulation, a reduced sleep quality and a lower and less stable self-esteem.
  2. Efficacy of CBTd-E: patients with acute delusions who receive CBTd-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.
  3. Mediation: the effect of CBTd-E on change in delusions is mediated by a) improved emotional stability and ability to regulate one's own emotions, b) improved sleep quality, c) improved and more stable self-esteem.

In addition to questionnaires and interviews, behavioral paradigms, psychophysiological assessments and electronic diaries will be used to test the hypotheses. If we can demonstrate that CBTd-E reduces delusions, this would provide us with a more acceptable and feasible therapy for treating delusions.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy and Mechanisms of Change of an Emotion-oriented Version of Cognitive-behavioral Therapy for Psychosis (CBTp-E) in Reducing Delusions. A Randomized-controlled Treatment Study (CBTd-E)
Study Start Date : May 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CBTd-E
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
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.
Other Name: CBTd-E

Placebo Comparator: Treatment as Usual
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
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.
Other Name: CBTd-E




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


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

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

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

  4. Change in Peters et al. Delusions Inventory (PDI- R) [ Time Frame: Change between pre-therapy and post-therapy assessment after six month ]
    Assessment of self-rated delusion frequency, conviction and distress.


Other Outcome Measures:
  1. Change in Emotion-regulation Questionnaire (ERQ) [ Time Frame: Change between pre-therapy and post-therapy assessment after six month ]
    Questionnaire assesses the regular use of emotion regulation strategies

  2. Change in Emotion regulation inventory [ Time Frame: Change between pre-therapy and post-therapy assessment after six month ]
    Questionnaire assesses the regular use of emotion regulation strategies

  3. Change in Paranoia assessed with Electronical mobile assessment [ Time Frame: Change between pre-therapy and post-therapy assessment after six month ]
    Assessment of present emotions, emotion regulation strategies, present symptoms of psychosis, present delusions, self-esteem for six consecutive days (10 assessments per day) in daily life

  4. Change in Sleep quality as assessed with an Actiwatch [ Time Frame: Change between pre-therapy and post-therapy assessment after six month ]
    Assessment of sleep-quality using an electronic bracelet for six consecutive days, sleep quality is assessed with movement detectors and light sensors

  5. Change in Emotion regulation quality as assessed experimental using International Affect Picture System Paradigm for the Assessment of emotion regulation (IAPS) [ Time Frame: Change between pre-therapy and post-therapy assessment after six month ]
    Assessment of effectiveness of use of emotion regulation strategies after experimental induction of fear, assessment of heart rate and skin conduction

  6. Change in heart rate variability [ Time Frame: Change between pre-therapy and post-therapy assessment after six month ]
    Assessment of heart rate variability with sensors during stress induction (reaction experiment) and during rest

  7. Change in Brief Core Schema Scale (BCSS) [ Time Frame: Change between pre-therapy and post-therapy assessment after six month ]
    Assessment of positive and negative self-schemata and schemata on others

  8. Change in Insomnia Severity Index (ISI) [ Time Frame: Change between pre-therapy and post-therapy assessment after six month ]
    The ISI assesses present sleep problems

  9. Change in Self-Compassion Scale (SCS) [ Time Frame: Change between pre-therapy and post-therapy assessment after six month ]
    SCS assesses self-compassion and self-esteem

  10. Change in Self-perception of emotional competencies (SEK-27) [ Time Frame: Change between pre-therapy and post-therapy assessment after six month ]
    Questionnaire assesses the regular use of emotion regulation strategies



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Treatment Group:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • acute suicidal tendency
  • comorbid diagnosis of borderline personality disorder and/or substance use disorder in the last six month
  • taking 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): NCT02787135


Contacts
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Contact: Stephanie Mehl, Ph. D. +491631879762 stephanie.mehl@staff.uni-marburg.de
Contact: Winfried Rief, Ph. D. +4964212823657 rief@staff.uni-marburg.de

Locations
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Germany
University of Marburg, Faculty of Clinical Psychology and Psychotherapy Recruiting
Marburg, Hessen, Germany, 35037
Contact: Laura Wendt, M. Sc.    004964212823838    laura.wendt@staff.uni-marburg.de   
Contact: Clara Nittel, M. Sc.    004964212823735    clara.nittel@staff.uni-marburg.de   
University of Hamburg, Faculty of Clinical Psychology and Psychotherapy Recruiting
Hamburg, Germany, 20146
Contact: Valeska Hug, M. Sc.    004940428385614    valeska.hug@uni-hamburg.de   
Contact: Julia Schulz, M. Sc.    004940428385584    julia.schulz-2@uni-hamburg.de   
Sponsors and Collaborators
Philipps University Marburg Medical Center
University of Hamburg
Ruhr University of Bochum
Investigators
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Study Chair: Stephanie Mehl, Ph. D. Philipps University Marburg Medical Center
Study Chair: Tania M Lincoln, Ph. D. University of Hamburg
Principal Investigator: Tobias Teismann, Ph. D. Ruhr University of Bochum

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Responsible Party: Prof. Dr. Stephanie Mehl, Prof. Dr. rer. nat., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT02787135     History of Changes
Other Study ID Numbers: CBTd-E_MehlLincoln2016
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Prof. Dr. Stephanie Mehl, Philipps University Marburg Medical Center:
Delusions
Schizophrenia
Cognitive Behavior Therapy
Emotion
Emotion regulation
self-esteem
sleep quality
Efficacy of change

Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Mental Disorders
Delusions
Schizophrenia Spectrum and Other Psychotic Disorders
Behavioral Symptoms