Metacognitive Training in Ultra-high Risk

NCT05827900 | Recruiting

• 1 other identifier: MCT in UHR 130323
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Ultra-high Risk for Psychosis; Clinical High Risk for Psychosis; At-risk Mental State

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in the Social and Occupational Functioning Assessment Scale (SOFAS) scores

  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.

  12, 26, 52 weeks

• Change in Positive and Negative Syndrome Scale (PANSS) total scores

  12, 26, 52 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Metacognitive Group Training

Behavioral: Metacognitive Training

Treatment as usual

NO INTERVENTION

Treatment as usual

Interventions

Metacognitive Training BEHAVIORAL

Minimum of 6 sessions; but planned 10-12 sessions of metacognitive group training

Intervention

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• (i) 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (2)

Department of Child and Adolescent Psychiatry

Vienna, Austria

RECRUITING

Department of Psychiatry and Psychotherapy

Vienna, Austria

RECRUITING

Study Officials

• Nilufar Mossaheb, MD

  Medical Univ. Vienna, Clinical Division of Social Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nilufar Mossaheb, MD

CONTACT

+4340400; nilufar.mossaheb@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof Dr

Model Details: Randomized prospective

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 25, 2023
• Study Start: October 21, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)