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Efficacy of Metacognitive Training Single Modules: Jumping to Conclusions and To Empathize...

Primary Purpose

Schizophrenia, Psychotic Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Metacognitive Training Jumping to Conclusion
Group discussion
Metacognitive Training To Empathize
Sponsored by
University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, randomized controlled trial, metacognitive training, single sessions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of psychotic disorders
  • informed consent

Exclusion Criteria:

  • neurological disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Sham Comparator

    Arm Label

    Jumping To Conculsions

    Theory of Mind

    Control

    Arm Description

    Metacognitive Training Jumping to conclusions module

    Metacognitive Training To empathize... module

    group discussion of current events

    Outcomes

    Primary Outcome Measures

    Fish Task
    variation of Beads Task used for measurement of jumping to conclusion
    Reading the Mind in the Eyes Test
    used for measurement of Theory of Mind aspects
    Cognitive Biases Questionnaire for Psychosis
    used for measurement of cognitive biases characteristic for psychotic patients

    Secondary Outcome Measures

    Symptom Checklist 27 plus
    screening tool for psychopathology symptoms
    Paranoia Checklist
    questionnaire used for assessment of paranoid ideation

    Full Information

    First Posted
    April 15, 2016
    Last Updated
    April 19, 2016
    Sponsor
    University of Warsaw
    Collaborators
    Medical University of Warsaw, Institute of Psychiatry and Neurology, Warsaw
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02748486
    Brief Title
    Efficacy of Metacognitive Training Single Modules: Jumping to Conclusions and To Empathize...
    Official Title
    Efficacy of Metacognitive Training Single Modules: Jumping to Conclusions and To Empathize... Among Patients of Psychiatric Rehabilitation Ward With Diagnosis of Schizophrenia.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Warsaw
    Collaborators
    Medical University of Warsaw, Institute of Psychiatry and Neurology, Warsaw

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether modules of Metacognitive Training: Jumping to Conclusions and To empathize... are effective in the treatment of patients with schizophrenia. Also it was investigated whether these modules have specific impact on cognitive biases severity.
    Detailed Description
    Investigators employ randomized controlled trial design. Patients in ward were recruited for the study in three waves. In each wave patients were assessed pre-intervention, then randomly allocated in one of three groups: with modules of Metacognitive Training or control group. Then patients were assessed post-intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia, Psychotic Disorders
    Keywords
    schizophrenia, randomized controlled trial, metacognitive training, single sessions

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Jumping To Conculsions
    Arm Type
    Experimental
    Arm Description
    Metacognitive Training Jumping to conclusions module
    Arm Title
    Theory of Mind
    Arm Type
    Experimental
    Arm Description
    Metacognitive Training To empathize... module
    Arm Title
    Control
    Arm Type
    Sham Comparator
    Arm Description
    group discussion of current events
    Intervention Type
    Behavioral
    Intervention Name(s)
    Metacognitive Training Jumping to Conclusion
    Intervention Description
    Therapeutical intervention based on cognitive-behavioural therapy paradigm. Addresses cognitive bias of schizophrenia patients - jumping to conclusion.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Group discussion
    Intervention Description
    Group discussion of current events
    Intervention Type
    Behavioral
    Intervention Name(s)
    Metacognitive Training To Empathize
    Intervention Description
    Therapeutical intervention based on cognitive-behavioural therapy paradigm. Addresses cognitive bias of schizophrenia patients - Theory of Mind deficits.
    Primary Outcome Measure Information:
    Title
    Fish Task
    Description
    variation of Beads Task used for measurement of jumping to conclusion
    Time Frame
    up to 3h after intervention
    Title
    Reading the Mind in the Eyes Test
    Description
    used for measurement of Theory of Mind aspects
    Time Frame
    up to 3h after intervention
    Title
    Cognitive Biases Questionnaire for Psychosis
    Description
    used for measurement of cognitive biases characteristic for psychotic patients
    Time Frame
    up to 3h after intervention
    Secondary Outcome Measure Information:
    Title
    Symptom Checklist 27 plus
    Description
    screening tool for psychopathology symptoms
    Time Frame
    up to 3h after intervention
    Title
    Paranoia Checklist
    Description
    questionnaire used for assessment of paranoid ideation
    Time Frame
    up to 3h after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosis of psychotic disorders informed consent Exclusion Criteria: neurological disorders
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Łukasz Gawęda, MD
    Organizational Affiliation
    Medical University of Warsaw
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25016771
    Citation
    Kuncewicz D, Dragan M, Hardt J. [Validation of the Polish version of the symptom checklist-27-plus questionnaire]. Psychiatr Pol. 2014 Mar-Apr;48(2):345-58. Polish.
    Results Reference
    background
    PubMed Identifier
    11280420
    Citation
    Baron-Cohen S, Wheelwright S, Hill J, Raste Y, Plumb I. The "Reading the Mind in the Eyes" Test revised version: a study with normal adults, and adults with Asperger syndrome or high-functioning autism. J Child Psychol Psychiatry. 2001 Feb;42(2):241-51.
    Results Reference
    background
    PubMed Identifier
    16004654
    Citation
    Moritz S, Woodward TS. Jumping to conclusions in delusional and non-delusional schizophrenic patients. Br J Clin Psychol. 2005 Jun;44(Pt 2):193-207. doi: 10.1348/014466505X35678.
    Results Reference
    background
    PubMed Identifier
    15863749
    Citation
    Freeman D, Garety PA, Bebbington PE, Smith B, Rollinson R, Fowler D, Kuipers E, Ray K, Dunn G. Psychological investigation of the structure of paranoia in a non-clinical population. Br J Psychiatry. 2005 May;186:427-35. doi: 10.1192/bjp.186.5.427.
    Results Reference
    background

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    Efficacy of Metacognitive Training Single Modules: Jumping to Conclusions and To Empathize...

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