NCT02748486

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable schizophrenia

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
Last Updated

April 22, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

April 15, 2016

Last Update Submit

April 19, 2016

Conditions

SchizophreniaPsychotic Disorders

Keywords

schizophreniarandomized controlled trialmetacognitive trainingsingle sessions

Outcome Measures

Primary Outcomes (3)

  • Fish Task

    variation of Beads Task used for measurement of jumping to conclusion

    up to 3h after intervention

  • Reading the Mind in the Eyes Test

    used for measurement of Theory of Mind aspects

    up to 3h after intervention

  • Cognitive Biases Questionnaire for Psychosis

    used for measurement of cognitive biases characteristic for psychotic patients

    up to 3h after intervention

Secondary Outcomes (2)

  • Symptom Checklist 27 plus

    up to 3h after intervention

  • Paranoia Checklist

    up to 3h after intervention

Study Arms (3)

Jumping To Conculsions

EXPERIMENTAL

Metacognitive Training Jumping to conclusions module

Behavioral: Metacognitive Training Jumping to Conclusion

Theory of Mind

EXPERIMENTAL

Metacognitive Training To empathize... module

Behavioral: Metacognitive Training To Empathize

Control

SHAM COMPARATOR

group discussion of current events

Behavioral: Group discussion

Interventions

Metacognitive Training Jumping to ConclusionBEHAVIORAL

Therapeutical intervention based on cognitive-behavioural therapy paradigm. Addresses cognitive bias of schizophrenia patients - jumping to conclusion.

Jumping To Conculsions
Group discussionBEHAVIORAL

Group discussion of current events

Control
Metacognitive Training To EmpathizeBEHAVIORAL

Therapeutical intervention based on cognitive-behavioural therapy paradigm. Addresses cognitive bias of schizophrenia patients - Theory of Mind deficits.

Theory of Mind

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of psychotic disorders
  • informed consent

You may not qualify if:

  • neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 25016771BACKGROUND

  • 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.

    PMID: 11280420BACKGROUND

  • 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.

    PMID: 16004654BACKGROUND

  • 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.

    PMID: 15863749BACKGROUND

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Łukasz Gawęda, MD

    Medical University of Warsaw

    STUDY CHAIR

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
MSSc

Study Record Dates

First Submitted

April 15, 2016

First Posted

April 22, 2016

Study Start

May 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

April 22, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share