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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05827900
Other study ID # MCT in UHR 130323
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 21, 2023
Est. completion date May 2026

Study information

Verified date March 2024
Source Medical University of Vienna
Contact Nilufar Mossaheb, MD
Phone +4340400
Email nilufar.mossaheb@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Description:

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Study Design


Intervention

Behavioral:
Metacognitive Training
Minimum of 6 sessions; but planned 10-12 sessions of metacognitive group training

Locations

Country Name City State
Austria Department of Child and Adolescent Psychiatry Vienna
Austria Department of Psychiatry and Psychotherapy Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12, 26, 52 weeks
Secondary 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. 12, 26, 52 weeks
Secondary 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.
12, 26, 52 weeks
Secondary 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. 12, 26, 52 weeks
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