SchizophreniaNCT05556941
Metacognitive Intervention for Individuals With Severe Mental Disorders
A study testing Metacognitive Group Intervention in people with Schizophrenia, run by University of Haifa.
Trial summary
The overall aim of this study was to develop a meta-cognitive group intervention in order to apply it and to understand and distinguish the components that influence participation among people with schizophrenia Read more about this study
- Who is it for?
- Ages 23 to 68 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Metacognitive Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 30 Apr 2016
- 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 23 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of schizophrenia by a licensed psychiatrist
- Fluency in Hebrew
- t-score of at least 65 on the Behavior Rating Inventory of Executive Function-Adult version
Who cannot join
- Severe psychiatric hospitalization of over 24 hours during the month prior to the beginning of the study
- Used drugs or alcohol
About this study
Official title: Development and Efficacy of Metacognitive Intervention for Individuals With Severe Mental Disorders
The overall aim of this study was to develop a meta-cognitive group intervention in order to apply it and to understand and distinguish the components that influence participation among people with schizophrenia
Read the detailed description
The overall aim of this study was to develop a Meta cognitive group intervention in order to apply it and to understand and distinguish the components that influence participation among people with schizophrenia. The specific objectives were to:
- Improve participation by increasing the effectiveness of cognitive strategy use and teaching clients to independently review performance and to examine the strategy's effectiveness.
- Compare the use of cognitive strategies between participants with schizophrenia and their matched controls following the Meta cognitive group intervention and to correlate the cognitive strategies use and participation following the Meta cognitive group.
- Examine whether symptoms moderate the association between metacognitive outcomes and participation among people with schizophrenia following the Meta cognitive group.
- Conditions
- Schizophrenia
- Being tested
- Metacognitive Group Intervention, Occupational therapy standard care
- Keywords
- Executive function, Meta-cognition, Schizophrenia, Meta-cognitive intervention
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive Group InterventionBehavioural
The investigators developed an initial Meta cognitive group intervention protocol based on the dynamic interactional model of cognition (Toglia, 2005), and specifically tailored it to individuals with schizophrenia.
Occupational therapy standard careBehavioural
Occupational therapy standard care
| Study group | Role | What they receive |
|---|---|---|
| Metacognitive Group Intervention | Experimental | Meta cognitive intervention protocol based on the dynamic interactional model of cognition (Toglia, 2005), and specifically tailored to individuals with schizophrenia. Receives: Behavioral: Metacognitive Group Intervention |
| Occupational therapy standard care | Active comparator | Standard care of occupational therapy in mental health, focused on work occupations. Receives: Behavioral: Occupational therapy standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale
The Positive and Negative Syndrome Scale is a 30-item scale with seven positive and seven negative symptoms items and 16 psychopathological items. The severity of each item is rated on a scale from 1 (none) to 7 (most severe). A general Positive and Negative Syndrome Scale score is between 30 (lack of symptoms) and 210 (very severe state of the disease). Potential ranges are 7 to 49 for the positive and negative symptom scales and from 16 to 12 for the general psychopathology scale.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Oct 2015
- Primary completion30 Apr 2016
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Before and after intervention
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naomi Josman, University of Haifa
- Investigators
- Naomi Josman, PhD, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556941
- Sponsor's protocol ID
- Kaizerman-Dinerman2022
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In accordance with the Helsinki Declaration and University ethical committee principles, the data used in this study cannot be made available because it was not anonymous.
Publications
Kaizerman-Dinerman A, Roe D, Josman N. An efficacy study of a metacognitive group intervention for people with schizophrenia. Psychiatry Res. 2018 Dec;270:1150-1156. doi: 10.1016/j.psychres.2018.10.037. Epub 2018 Oct 13.
PubMed 30482631Kaizerman-Dinerman A, Josman, Roe D. The use of cognitive strategies among people with schizophrenia: a randomized comparative study. The Open Journal of Occupational Therapy. 2019; 7(3): 1-12.
Kaizerman-Dinerman A, Roe D, Demeter N, Josman N. Do symptoms moderate the association between participation and executive functions outcomes among people with schizophrenia? BMC Psychiatry. 2023 Jan 17;23(1):42. doi: 10.1186/s12888-022-04510-0.
PubMed 36650458
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Efficacy of Metacognitive Intervention for Individuals With Severe Mental Disorders
- ClinicalTrials.gov ID
- NCT05556941
- Acronym / sponsor ID
- Kaizerman-Dinerman2022
- Conditions
- Schizophrenia
- Keywords
- Executive function, Meta-cognition, Schizophrenia, Meta-cognitive intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 27 Sep 2022 (actual)
- 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 overall aim of this study was to develop a meta-cognitive group intervention in order to apply it and to understand and distinguish the components that influence participation among people with schizophrenia
Detailed description
The overall aim of this study was to develop a Meta cognitive group intervention in order to apply it and to understand and distinguish the components that influence participation among people with schizophrenia. The specific objectives were to:
- Improve participation by increasing the effectiveness of cognitive strategy use and teaching clients to independently review performance and to examine the strategy's effectiveness.
- Compare the use of cognitive strategies between participants with schizophrenia and their matched controls following the Meta cognitive group intervention and to correlate the cognitive strategies use and participation following the Meta cognitive group.
- Examine whether symptoms moderate the association between metacognitive outcomes and participation among people with schizophrenia following the Meta cognitive group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Before and after intervention
| Arm | Type | Receives |
|---|---|---|
| Metacognitive Group Intervention | Experimental | Behavioral: Metacognitive Group InterventionMeta cognitive intervention protocol based on the dynamic interactional model of cognition (Toglia, 2005), and specifically tailored to individuals with schizophrenia. |
| Occupational therapy standard care | Active comparator | Behavioral: Occupational therapy standard careStandard care of occupational therapy in mental health, focused on work occupations. |
Who may qualify
- Ages
- 23 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of schizophrenia by a licensed psychiatrist
- Fluency in Hebrew
- t-score of at least 65 on the Behavior Rating Inventory of Executive Function-Adult version
Key exclusion criteria (2 listed)
- Severe psychiatric hospitalization of over 24 hours during the month prior to the beginning of the study
- Used drugs or alcohol
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 Group InterventionThe investigators developed an initial Meta cognitive group intervention protocol based on the dynamic interactional model of cognition (Toglia, 2005), and specifically tailored it to individuals with schizophrenia. | Behavioural | Metacognitive Group Intervention |
| Occupational therapy standard careOccupational therapy standard care | Behavioural | Occupational therapy standard care |
Primary outcome
Positive and Negative Syndrome Scale
Time frame: 15 minutes
The Positive and Negative Syndrome Scale is a 30-item scale with seven positive and seven negative symptoms items and 16 psychopathological items. The severity of each item is rated on a scale from 1 (none) to 7 (most severe). A general Positive and Negative Syndrome Scale score is between 30 (lack of symptoms) and 210 (very severe state of the disease). Potential ranges are 7 to 49 for the positive and negative symptom scales and from 16 to 12 for the general psychopathology scale.
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 3 Oct 2022.
- Results publication: PubMed 30482631Kaizerman-Dinerman A, Roe D, Josman N. An efficacy study of a metacognitive group intervention for people with schizophrenia. Psychiatry Res. 2018 Dec;270:1150-1156. doi: 10.1016/j.psychres.2018.10.037. Epub 2018 Oct 13.
- Results publicationKaizerman-Dinerman A, Josman, Roe D. The use of cognitive strategies among people with schizophrenia: a randomized comparative study. The Open Journal of Occupational Therapy. 2019; 7(3): 1-12.
- Derived from this study: PubMed 36650458Kaizerman-Dinerman A, Roe D, Demeter N, Josman N. Do symptoms moderate the association between participation and executive functions outcomes among people with schizophrenia? BMC Psychiatry. 2023 Jan 17;23(1):42. doi: 10.1186/s12888-022-04510-0.
- Individual participant dataSharing planned: No. In accordance with the Helsinki Declaration and University ethical committee principles, the data used in this study cannot be made available because it was not anonymous.
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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.
Naomi Josman, PhD principal investigator
University of Haifa
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Group Intervention in people with Schizophrenia, run by University of Haifa.
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 3 inclusion and 2 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 3 Oct 2022. 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. 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?
Positive and Negative Syndrome Scale (time frame: 15 minutes). 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 NCT05556941, which also lists 3 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 3 Oct 2022.