Ultra-high Risk for PsychosisNCT05827900
Metacognitive Training in Ultra-high Risk
A study testing Metacognitive Training in people with Ultra-high Risk for Psychosis and Clinical High Risk for Psychosis, run by Medical University of Vienna at 2 sites in Austria.
Trial summary
The aim of this pilot study is to examine whether metacognitive training can improve symptoms, wellbeing and functioning in individuals with attenuated psychotic symptoms. Metacognitive group training is an intervention designed to raise awareness on and change cognitive biases that may foster the development of… Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Ultra-high Risk for Psychosis, Clinical High Risk for Psychosis, At-risk Mental State
- What is being tested?
- Metacognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesAustria
- Study dates
- 21 Oct 2023to May 2026
- 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 16-40 years; (ii) individuals belonging to either one of the following two groups:
- attenuated psychotic symptoms (APS): Experience of subthreshold, attenuated forms of positive psychotic symptoms including ideas of reference, odd beliefs or magical thinking, perceptual disturbance, paranoid ideation, odd thinking and speech, odd behavior and appearance, at least several times per week within the last year, present for at least one week and no longer than five years, according to the criteria operationalized in the Comprehensive Assessment of At Risk Mental State (CAARMS) interview (Yung et al., 2003);
- brief limited intermittent psychotic symptoms (BLIPS): Episodes of frank psychotic symptoms that have not lasted longer than a week and have spontaneously abated, according to the criteria operationalized in the CAARMS interview (Yung et al., 2003); (iii) ability to give informed consent and to follow study procedures
Who cannot join
- Past history of a treated or untreated manifest psychotic episode of one week's duration or longer (ii) Increases of dosages of antipsychotic medications - if any is given at all - within the last two weeks and/or clinical necessity for dosage increases at time of inclusion; (iii) Past neuroleptic exposure exceeding a total lifetime haloperidol dose of 50 mg (equivalent doses as referred to in Gardner, Murphy, O'Donnell, Centorrino, and Baldessarini (2010)); (iv) Acute suicidality or acute aggressive behavior; (v) Current attenuated symptoms that are entirely explained by acute intoxication (e.g., current attenuated symptoms entirely explained by LSD use) (vi) Organic brain disease (e.g. epilepsy, inflammatory brain disease etc.); (vii) Any other physical illness with psychotropic effect, if not stabilized; (viii) Diagnosis of a serious developmental disorder, e.g. Asperger ́s syndrome; (ix) Premorbid IQ lower than 70; (x) Inadequate knowledge of German language
Trial locations and contacts
2 sites in 1 country.
Austria2 sites, 2 recruiting
- Recruiting
Department of Child and Adolescent Psychiatry
Vienna
Christian Scharinger
- Recruiting
Department of Psychiatry and Psychotherapy
Vienna
Nilufar Mossaheb, MD, +4314040036030
About this study
Official title: Metacognitive Training in Individuals at Risk for Psychosis - a Pilot Study
The aim of this pilot study is to examine whether metacognitive training can improve symptoms, wellbeing and functioning in individuals with attenuated psychotic symptoms. Metacognitive group training is an intervention designed to raise awareness on and change cognitive biases that may foster the development of psychotic symptoms such as delusions. It has been shown to be helpful in people with manifest psychosis. The main goal is to assess whether this training is prone to reducing symptoms in individuals at risk for psychosis. Participants will be randomized either to treatment as usual or to treatment as usual plus metacognitive training. Follow-ups will be performed over the period of one year.
Read the detailed description
Background: Different metacognitive distortions similar to those of patients with schizophrenia could be shown in individuals with attenuated psychotic symptoms at ultra-high risk for psychosis (UHR) including more dysfunctional metacognitive beliefs, overconfidence in judgements, a jumping-to- conclusion reasoning style associated with impaired working memory, a metamemory bias and intolerance of uncertainty. Recent research points towards a positive effect of metacognitive training (MCT) on positive symptoms, data gathering and delusions in patients with schizophrenia by raising awareness for cognitive biases.
Aims: The aim of this study is to examine whether metacognitive training can improve psychopathology in individuals with attenuated psychotic symptoms via changes in metacognitive biases and beliefs. Study design: The study is randomized-controlled, prospective.
Methods: 15 individuals fulfilling UHR criteria will be randomly assigned to a group receiving MCT+treatment as usual (TAU) at an early psychosis clinic for a duration of approximately 8-12 weeks and 15 individuals fulfilling UHR criteria will receive TAU only. Both groups will undergo psychiatric assessments to exclude current or past psychiatric disorders as well as psychosis threshold and current psychopathology. Also, an assessment of IQ, psychosocial functioning and metacognitive biases and beliefs will be done. Assessments will be done at baseline, after 12, 26 and 52 weeks.
Study sample: The study sample will consist of 30 individuals at UHR between 16 and 40 years of age.
Main outcome variable: Changes in the positive subscale score as a measure of positive symptoms of the Positive and Negative Syndrome Scale (PANSS) Secondary outcome variables: (i) Changes in SOFAS score; (ii) Changes in metacognitive biases and beliefs; (iii) Changes in PANSS total score Power analysis: The aim of this pilot study is to better understand the magnitude of the treatment effect and its variability, such that future studies can be properly powered. A sample size of 15 in each group was decided upon, with an asymptotic, two-sided 95% confidence interval.
- Being tested
- Metacognitive Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive TrainingBehavioural
Minimum of 6 sessions; but planned 10-12 sessions of metacognitive group training
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Metacognitive Group Training Receives: Behavioral: Metacognitive Training |
| Treatment as usual | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Positive and Negativ Syndrome Scale (PANSS) positive subscale
The positive subscale of the PANSS is a scale rating the positive psychotic symptoms of an individual, where higher scores mean more symptoms. It consists of 7 items, where each item is rated from 1-7. So the minimum score is 7 and the maximum score is 49.
Measured: 12, 26, 52 weeks
Secondary outcomes (3)
Change in the Social and Occupational Functioning Assessment Scale (SOFAS) scores
The SOFAS is a scale used to rate current social and occupational functioning of an individual.To be rated a reduction in functioning must be directly related to mental or physical health issues. The scale is rated between 0-100, where higher scores mean higher functioning.
Measured: 12, 26, 52 weeks
Change in metacognitive biases: Metacognitions-Questionnaire-30 (MCQ-30), Beck Cognitive Insight Scale (BCIS), Fish Task, Davos Assessment of Cognitive Biases Scale (DACOBS), Reading the Mind in the Eyes (RMET) Test.
MCQ-30 is a 65-item scale to assess metacognition. Each item is rated on a 4-point scale.
BCIS is a 15-items self administered scale assessing cognitive insight. It has a rating from 1-4 (do not agree to agree completely). Fish task is used to assess jumping to conclusion; the patient has the task to decide whether a fish comes from pond A or B according to subjective probabilities. RMET is a 36-item test to assess Theory of Mind; one has to guess the correct adjective best describing a set of eyes among 4 adjectives presented; each correct answer is rated with 1 point; a higher score meaning better Theory of mind. DACOBS is a 42 items scale used to assess cognitive biases specific to positive symptoms; each item is rated from 1-7, 7 subscales are calculated from the items, higher scores meaning more cognitive biases.
Measured: 12, 26, 52 weeks
Change in Positive and Negative Syndrome Scale (PANSS) total scores
The PANSS is a scale to rate positive, negative an global symptoms in schizophrenia. The positive subscale consists of 7 items, as well as the negative subscale, the global subscale consists of 16 items. Each item is rated from 1-7, where higher scores mean more severe symptoms. The minimum PANSS total score is 30, the maximum is 210.
Measured: 12, 26, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start21 Oct 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultra-high Risk for PsychosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Model description
- Randomized prospective
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilufar Mossaheb, Medical University of Vienna
- Investigators
- Nilufar Mossaheb, MD, Principal investigator, Medical Univ. Vienna, Clinical Division of Social Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827900
- Sponsor's protocol ID
- MCT in UHR 130323
- Status last verified
- Mar 2024
- First submitted
- 11 Apr 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognitive Training in Individuals at Risk for Psychosis - a Pilot Study
- ClinicalTrials.gov ID
- NCT05827900
- Acronym / sponsor ID
- MCT in UHR 130323
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 21 Oct 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 25 Apr 2023 (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 aim of this pilot study is to examine whether metacognitive training can improve symptoms, wellbeing and functioning in individuals with attenuated psychotic symptoms. Metacognitive group training is an intervention designed to raise awareness on and change cognitive biases that may foster the development of psychotic symptoms such as delusions. It has been shown to be helpful in people with manifest psychosis. The main goal is to assess whether this training is prone to reducing symptoms in individuals at risk for psychosis. Participants will be randomized either to treatment as usual or to treatment as usual plus metacognitive training. Follow-ups will be performed over the period of one year.
Detailed description
Background: Different metacognitive distortions similar to those of patients with schizophrenia could be shown in individuals with attenuated psychotic symptoms at ultra-high risk for psychosis (UHR) including more dysfunctional metacognitive beliefs, overconfidence in judgements, a jumping-to- conclusion reasoning style associated with impaired working memory, a metamemory bias and intolerance of uncertainty. Recent research points towards a positive effect of metacognitive training (MCT) on positive symptoms, data gathering and delusions in patients with schizophrenia by raising awareness for cognitive biases.
Aims: The aim of this study is to examine whether metacognitive training can improve psychopathology in individuals with attenuated psychotic symptoms via changes in metacognitive biases and beliefs. Study design: The study is randomized-controlled, prospective.
Methods: 15 individuals fulfilling UHR criteria will be randomly assigned to a group receiving MCT+treatment as usual (TAU) at an early psychosis clinic for a duration of approximately 8-12 weeks and 15 individuals fulfilling UHR criteria will receive TAU only. Both groups will undergo psychiatric assessments to exclude current or past psychiatric disorders as well as psychosis threshold and current psychopathology. Also, an assessment of IQ, psychosocial functioning and metacognitive biases and beliefs will be done. Assessments will be done at baseline, after 12, 26 and 52 weeks.
Study sample: The study sample will consist of 30 individuals at UHR between 16 and 40 years of age.
Main outcome variable: Changes in the positive subscale score as a measure of positive symptoms of the Positive and Negative Syndrome Scale (PANSS) Secondary outcome variables: (i) Changes in SOFAS score; (ii) Changes in metacognitive biases and beliefs; (iii) Changes in PANSS total score Power analysis: The aim of this pilot study is to better understand the magnitude of the treatment effect and its variability, such that future studies can be properly powered. A sample size of 15 in each group was decided upon, with an asymptotic, two-sided 95% confidence interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized prospective
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Metacognitive TrainingMetacognitive Group Training |
| Treatment as usual | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 16-40 years; (ii) individuals belonging to either one of the following two groups:
- attenuated psychotic symptoms (APS): Experience of subthreshold, attenuated forms of positive psychotic symptoms including ideas of reference, odd beliefs or magical thinking, perceptual disturbance, paranoid ideation, odd thinking and speech, odd behavior and appearance, at least several times per week within the last year, present for at least one week and no longer than five years, according to the criteria operationalized in the Comprehensive Assessment of At Risk Mental State (CAARMS) interview (Yung et al., 2003);
- brief limited intermittent psychotic symptoms (BLIPS): Episodes of frank psychotic symptoms that have not lasted longer than a week and have spontaneously abated, according to the criteria operationalized in the CAARMS interview (Yung et al., 2003); (iii) ability to give informed consent and to follow study procedures
Key exclusion criteria (1 listed)
- Past history of a treated or untreated manifest psychotic episode of one week's duration or longer (ii) Increases of dosages of antipsychotic medications - if any is given at all - within the last two weeks and/or clinical necessity for dosage increases at time of inclusion; (iii) Past neuroleptic exposure exceeding a total lifetime haloperidol dose of 50 mg (equivalent doses as referred to in Gardner, Murphy, O'Donnell, Centorrino, and Baldessarini (2010)); (iv) Acute suicidality or acute aggressive behavior; (v) Current attenuated symptoms that are entirely explained by acute intoxication (e.g., current attenuated symptoms entirely explained by LSD use) (vi) Organic brain disease (e.g. epilepsy, inflammatory brain disease etc.); (vii) Any other physical illness with psychotropic effect, if not stabilized; (viii) Diagnosis of a serious developmental disorder, e.g. Asperger ́s syndrome; (ix) Premorbid IQ lower than 70; (x) Inadequate knowledge of German language
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 TrainingMinimum of 6 sessions; but planned 10-12 sessions of metacognitive group training | Behavioural | Intervention |
Primary outcome
Change Positive and Negativ Syndrome Scale (PANSS) positive subscale
Time frame: 12, 26, 52 weeks
The positive subscale of the PANSS is a scale rating the positive psychotic symptoms of an individual, where higher scores mean more symptoms. It consists of 7 items, where each item is rated from 1-7. So the minimum score is 7 and the maximum score is 49.
3 secondary outcomes
Change in the Social and Occupational Functioning Assessment Scale (SOFAS) scores
Time frame: 12, 26, 52 weeks
Change in metacognitive biases: Metacognitions-Questionnaire-30 (MCQ-30), Beck Cognitive Insight Scale (BCIS), Fish Task, Davos Assessment of Cognitive Biases Scale (DACOBS), Reading the Mind in the Eyes (RMET) Test.
Time frame: 12, 26, 52 weeks
Change in Positive and Negative Syndrome Scale (PANSS) total scores
Time frame: 12, 26, 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- 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.
Nilufar Mossaheb, MD principal investigator
Medical Univ. Vienna, Clinical Division of Social Psychiatry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Training in people with Ultra-high Risk for Psychosis and Clinical High Risk for Psychosis, run by Medical University of Vienna at 2 sites in Austria.
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 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nilufar Mossaheb, MD (+4340400 ext. 351490, nilufar.mossaheb@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Positive and Negativ Syndrome Scale (PANSS) positive subscale (time frame: 12, 26, 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2024.