NCT05827900

Metacognitive Training in Ultra-high Risk

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 16 Years – 40 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Metacognitive Training	Minimum of 6 sessions; but planned 10-12 sessions of metacognitive group training

Timeline

• Start date: 2023-10-21
• Primary completion: 2025-05-01
• Completion: 2026-05-01
• First posted: 2023-04-25
• Last updated: 2024-03-15

Locations

2 sites across 1 country: Austria