Metacognitive training for individuals at ultra-high risk for psychosis

Metacognitive Training in Individuals at Risk for Psychosis - a Pilot Study

This study is testing if adding metacognitive training to regular treatment can help people at high risk for psychosis feel better and improve their daily functioning.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 16 Years to 40 Years
• Sex: All
• Sponsor: Medical University of Vienna (Academic / other)
• Locations: 2 sites (Vienna and 1 other locations)
• Trial ID: NCT05827900 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the effectiveness of metacognitive training in improving symptoms, wellbeing, and functioning in individuals experiencing attenuated psychotic symptoms. Participants will be randomly assigned to receive either standard treatment or standard treatment plus metacognitive training over a period of 8-12 weeks. The study will assess changes in metacognitive biases and beliefs, as well as overall psychopathology, through psychiatric evaluations at multiple follow-up points over one year. The goal is to determine if this training can help reduce the risk of developing full-blown psychosis.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 16-40 who exhibit attenuated psychotic symptoms or brief limited intermittent psychotic symptoms.

Not a fit: Patients with a history of full-blown psychosis or other severe psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the risk of developing psychosis in at-risk individuals.

How similar studies have performed: Previous studies have shown positive effects of metacognitive training in individuals with manifest psychosis, suggesting potential for success in this at-risk population.

Eligibility criteria

Inclusion Criteria:

(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

Exclusion Criteria:

(i) 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

Where this trial is running

Vienna and 1 other locations

• Department of Child and Adolescent Psychiatry — Vienna, Austria (Recruiting)
• Department of Psychiatry and Psychotherapy — Vienna, Austria (Recruiting)

Study contacts

• Principal investigator: Nilufar Mossaheb, MD — Medical Univ. Vienna, Clinical Division of Social Psychiatry
• Study coordinator: Nilufar Mossaheb, MD

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