SchizophreniaNCT02748486
Efficacy of Metacognitive Training Single Modules: Jumping to Conclusions and To Empathize...
A study testing Metacognitive Training Jumping to Conclusion, Group discussion and Metacognitive Training To Empathize in people with Schizophrenia and Psychotic Disorders, run by University of Warsaw.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Psychotic Disorders
- What is being tested?
- Metacognitive Training Jumping to Conclusion, Group discussion and Metacognitive Training To Empathize
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of psychotic disorders
- informed consent
Who cannot join
- neurological disorders
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia, Psychotic Disorders
- Being tested
- Metacognitive Training Jumping to Conclusion, Group discussion, Metacognitive Training To Empathize
- Keywords
- schizophrenia, randomized controlled trial, metacognitive training, single sessions
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive Training Jumping to ConclusionBehavioural
Therapeutical intervention based on cognitive-behavioural therapy paradigm. Addresses cognitive bias of schizophrenia patients - jumping to conclusion.
Group discussionBehavioural
Group discussion of current events
Metacognitive Training To EmpathizeBehavioural
Therapeutical intervention based on cognitive-behavioural therapy paradigm. Addresses cognitive bias of schizophrenia patients - Theory of Mind deficits.
| Study group | Role | What they receive |
|---|---|---|
| Jumping To Conculsions | Experimental | Metacognitive Training Jumping to conclusions module Receives: Behavioral: Metacognitive Training Jumping to Conclusion |
| Theory of Mind | Experimental | Metacognitive Training To empathize... module Receives: Behavioral: Metacognitive Training To Empathize |
| Control | Sham comparator | group discussion of current events Receives: Behavioral: Group discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fish Task
variation of Beads Task used for measurement of jumping to conclusion
Measured: up to 3h after intervention
Reading the Mind in the Eyes Test
used for measurement of Theory of Mind aspects
Measured: up to 3h after intervention
Cognitive Biases Questionnaire for Psychosis
used for measurement of cognitive biases characteristic for psychotic patients
Measured: up to 3h after intervention
Secondary outcomes (2)
Symptom Checklist 27 plus
screening tool for psychopathology symptoms
Measured: up to 3h after intervention
Paranoia Checklist
questionnaire used for assessment of paranoid ideation
Measured: up to 3h after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startMay 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Warsaw, Institute of Psychiatry and Neurology, Warsaw
- Responsible party
- Principal investigator, Joachim Kowalski, University of Warsaw
- Investigators
- Łukasz Gawęda, MD, Study chair, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748486
- Sponsor's protocol ID
- BadaniaWłasne0001
- Status last verified
- Apr 2016
- First submitted
- 15 Apr 2016
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25016771Baron-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.
PubMed 11280420Moritz 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.
PubMed 16004654Freeman 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.
PubMed 15863749
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Metacognitive Training Single Modules: Jumping to Conclusions and To Empathize... Among Patients of Psychiatric Rehabilitation Ward With Diagnosis of Schizophrenia.
- ClinicalTrials.gov ID
- NCT02748486
- Acronym / sponsor ID
- BadaniaWłasne0001
- Conditions
- Schizophrenia, Psychotic Disorders
- Keywords
- schizophrenia, randomized controlled trial, metacognitive training, single sessions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of WarsawUniversity, hospital or other
- Collaborators
- Medical University of Warsaw, Institute of Psychiatry and Neurology, Warsaw
- Study start
- May 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Jumping To Conculsions | Experimental | Behavioral: Metacognitive Training Jumping to ConclusionMetacognitive Training Jumping to conclusions module |
| Theory of Mind | Experimental | Behavioral: Metacognitive Training To EmpathizeMetacognitive Training To empathize... module |
| Control | Sham comparator | Behavioral: Group discussiongroup discussion of current events |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of psychotic disorders
- informed consent
Key exclusion criteria (1 listed)
- neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive Training Jumping to ConclusionTherapeutical intervention based on cognitive-behavioural therapy paradigm. Addresses cognitive bias of schizophrenia patients - jumping to conclusion. | Behavioural | Jumping To Conculsions |
| Group discussionGroup discussion of current events | Behavioural | Control |
| Metacognitive Training To EmpathizeTherapeutical intervention based on cognitive-behavioural therapy paradigm. Addresses cognitive bias of schizophrenia patients - Theory of Mind deficits. | Behavioural | Theory of Mind |
Primary outcome
Fish Task
Time frame: up to 3h after intervention
variation of Beads Task used for measurement of jumping to conclusion
Reading the Mind in the Eyes Test
Time frame: up to 3h after intervention
used for measurement of Theory of Mind aspects
Cognitive Biases Questionnaire for Psychosis
Time frame: up to 3h after intervention
used for measurement of cognitive biases characteristic for psychotic patients
2 secondary outcomes
Symptom Checklist 27 plus
Time frame: up to 3h after intervention
Paranoia Checklist
Time frame: up to 3h after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- Background: PubMed 25016771Kuncewicz 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.
- Background: PubMed 11280420Baron-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.
- Background: PubMed 16004654Moritz 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.
- Background: PubMed 15863749Freeman 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.
- Polish version of Metacognitive TrainingLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Łukasz Gawęda, MD study chair
Medical University of Warsaw
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Training Jumping to Conclusion, Group discussion and Metacognitive Training To Empathize in people with Schizophrenia and Psychotic Disorders, run by University of Warsaw.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fish Task (time frame: up to 3h after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02748486, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2016.