The Efficacy of Metacognitive Skills Training in the Context of Forensic Psychiatric Care

NCT06005766 | Recruiting

• 1 other identifier: VVSJYUMCT01
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Deficiencies in social cognition are part of the core symptomatology of psychotic disorders. And deficiencies in social cognition, the closely related concept of metacognition, and, for example, paranoid attitudes are all associated with violence. The link between social cognition and violence is also observed through rehabilitation, as both group-based Social Cognition Interaction Training (SCIT) and group-based Metacognitive Skills Training (MCT) have reduced violent behavior in patients with psychotic disorders. Thus, a better knowledge of social cognition and its rehabilitation in psychotic disorders can help to reduce risky behavior and to rehabilitate the significant social difficulties often found in psychotic disorders. This research study aims to examine factors underlying the efficacy of group-based MCT. The goal of the metacognitive skills training group developed by Moritz and partners is to strengthen the social and metacognitive skills of the patients participating in the group. The group consists of 10 sessions during which exercises and discussion are emphasized. The themes of the group sessions are, for example, jumping to conclusions -bias, empathy, and memory. Detailed information is available from the MCT website (https://clinical-neuropsychology.de/metacognitive\_training-psychosis/). Overall there is meta-analysis-level evidence for the moderate effectiveness of MCT on positive symptoms of psychotic illnesses, such as delusions. Prior studies have argued that the unique factor underpinning MCT's efficacy is its impact on various cognitive biases, and that participating in the group especially reduces patients' tendency to jump to conclusions, which is a cognitive style associated with delusions and deficits in social perception and reasoning. As delusionality is related to the risk of violence, these results form a logical link between jumping to conclusions, delusionality, and violence. But the results regarding the effectiveness of MCT are still somewhat conflicting, and studies seem to be of varying quality. Additional longitudinal research and research related to the jumping to conclusion bias are also needed. The hypothesis regarding this study is that the MCT group reduces patients' tendency to jump to conclusions. These reductions are presumed to be associated in one-year follow-up with fewer mood symptoms, delusions, paranoia, and more psychological flexibility.

Conditions

Schizophrenia; Schizoaffective Disorder; Psychotic Disorders; Delusional Disorder; Psychotic Depression

Keywords

Social Cognition; Metacognitive Skills Training; Forensic Psychology; Forensic Psychiatry; Violence

Outcome Measures

Primary Outcomes (1)

• Jumping to conclusions bias

  The bias is measured using a revised version of the beads task. This is a test of optimal performance, meaning that both low and high scores can be problematic.

  For the intervention group, the measurement is done before the group and nine months after completion. For the control groups, the time interval is one year.

Secondary Outcomes (3)

• Paranoia and psychotic experiences

  For the intervention group, the measurement is done before the group and nine months after completion. For the control groups, the time interval is one year.

• Mood symptoms

  For the intervention group, the measurement is done before the group and nine months after completion. For the control groups, the time interval is one year.

• Psychological flexibility

  For the intervention group, the measurement is done before the group and nine months after completion. For the control groups, the time interval is one year.

Study Arms (3)

Intervention group

EXPERIMENTAL

Patients with a psychosis spectrum disorder participating in the group-based metacognitive skills training and receiving treatment as usual

Behavioral: Metacognitive Skills Training (MCT); Other: Treatment as usual

Patient controls

ACTIVE COMPARATOR

Patients with a psychosis spectrum disorder receiving standard long-term care in the hospital

Other: Treatment as usual

Non-patient controls

NO INTERVENTION

Control group consisting of test subjects without a diagnosis of psychosis spectrum disorder

Interventions

Metacognitive Skills Training (MCT) BEHAVIORAL

The goal of the metacognitive skills training group developed by Moritz and co. is to strengthen the social and metacognitive skills of the patients participating in the group. The group consists of 10 sessions during which exercises and discussion are emphasized. The themes of the group sessions are, for example, jumping to conclusions -bias, empathy, and memory. Detailed information is available from the MCT website (https://clinical-neuropsychology.de/metacognitive\_training-psychosis/). Overall there is meta-analysis-level evidence for the moderate effectiveness of MCT on positive symptoms of psychotic illnesses, such as delusions. Prior studies have argued that the unique factor underpinning MCT's efficacy is its impact on various cognitive biases, and that participating in the group especially reduces patients' tendency to jump to conclusions, which is a cognitive style associated with delusions and deficits in social perception and reasoning.

Intervention group

Treatment as usual OTHER

Medicinal treatment deemed appropriate by the attending physician, psychiatric ward treatment, and others forms of treatment recommended to the patients based on their treatment plans (e.g., work therapy, dialectical behavior therapy, talk therapy)

Intervention group; Patient controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to participate in a scientific study
• Diagnosis of a psychosis spectrum disorder
• Finnish language skills due to questionnaires and psychological tests being in Finnish

You may not qualify if:

• Psychosis that severely deteriorates the ability to function
• Cognitive problems that severely deteriorate the ability to function
• Guardianship established for personal matters
• Willingness to participate in a scientific study
• Self-assessed sufficient Finnish language skills due to questionnaires and psychological tests being in Finnish
• Diagnosis of a psychosis spectrum disorder
• Cognitive problems that severely interferes with functioning

Sponsors & Collaborators

• University of Jyvaskyla: lead
• Vanha Vaasa Hospital: collaborator

Study Sites (1)

Vanha Vaasa Hospital

Vaasa, Finland

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Schizophrenia, Paranoid

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Raimo Lappalainen, PhD

  University of Jyvaskyla

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leo Kuutti, MA

CONTACT

029 524 3058; leo.kuutti@vvs.fi

Alice Keski-Valkama, PhD

CONTACT

029 524 3055; Alice.keski-valkama@vvs.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There are three groups in the study. One is the intervention group (n=20-25), one consists of patient controls (n=30), and the last one consists of non-patient controls (n=30).

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 22, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

FI (1)