- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02748486
Efficacy of Metacognitive Training Single Modules: Jumping to Conclusions and To Empathize...
April 19, 2016 updated by: Joachim Kowalski, University of Warsaw
Efficacy of Metacognitive Training Single Modules: Jumping to Conclusions and To Empathize... Among Patients of Psychiatric Rehabilitation Ward With Diagnosis of Schizophrenia.
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosis of psychotic disorders
- informed consent
Exclusion Criteria:
- neurological disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Jumping To Conculsions
Metacognitive Training Jumping to conclusions module
|
Therapeutical intervention based on cognitive-behavioural therapy paradigm.
Addresses cognitive bias of schizophrenia patients - jumping to conclusion.
|
|
Experimental: Theory of Mind
Metacognitive Training To empathize... module
|
Therapeutical intervention based on cognitive-behavioural therapy paradigm.
Addresses cognitive bias of schizophrenia patients - Theory of Mind deficits.
|
|
Sham Comparator: Control
group discussion of current events
|
Group discussion of current events
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fish Task
Time Frame: up to 3h after intervention
|
variation of Beads Task used for measurement of jumping to conclusion
|
up to 3h after intervention
|
|
Reading the Mind in the Eyes Test
Time Frame: up to 3h after intervention
|
used for measurement of Theory of Mind aspects
|
up to 3h after intervention
|
|
Cognitive Biases Questionnaire for Psychosis
Time Frame: up to 3h after intervention
|
used for measurement of cognitive biases characteristic for psychotic patients
|
up to 3h after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptom Checklist 27 plus
Time Frame: up to 3h after intervention
|
screening tool for psychopathology symptoms
|
up to 3h after intervention
|
|
Paranoia Checklist
Time Frame: up to 3h after intervention
|
questionnaire used for assessment of paranoid ideation
|
up to 3h after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Łukasz Gawęda, MD, Medical University of Warsaw
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
April 15, 2016
First Submitted That Met QC Criteria
April 19, 2016
First Posted (Estimate)
April 22, 2016
Study Record Updates
Last Update Posted (Estimate)
April 22, 2016
Last Update Submitted That Met QC Criteria
April 19, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BadaniaWłasne0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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