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Completed

NCT Number: NCT05556941

Metacognitive Intervention for Individuals With Severe Mental Disorders

The overall aim of this study was to develop a meta-cognitive group intervention in order to apply it and to understand and distinguish the components that influence participation among people with schizophrenia

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Key information

Age range

23 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The overall aim of this study was to develop a Meta cognitive group intervention in order to apply it and to understand and distinguish the components that influence participation among people with schizophrenia. The specific objectives were to:

  • Improve participation by increasing the effectiveness of cognitive strategy use and teaching clients to independently review performance and to examine the strategy's effectiveness.
  • Compare the use of cognitive strategies between participants with schizophrenia and their matched controls following the Meta cognitive group intervention and to correlate the cognitive strategies use and participation following the Meta cognitive group.
  • Examine whether symptoms moderate the association between metacognitive outcomes and participation among people with schizophrenia following the Meta cognitive group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of schizophrenia by a licensed psychiatrist
  • Fluency in Hebrew
  • t-score of at least 65 on the Behavior Rating Inventory of Executive Function-Adult version

Exclusion criteria

  • Severe psychiatric hospitalization of over 24 hours during the month prior to the beginning of the study
  • Used drugs or alcohol

Treatment and study plan

Metacognitive Group Intervention

Behavioral

The investigators developed an initial Meta cognitive group intervention protocol based on the dynamic interactional model of cognition (Toglia, 2005), and specifically tailored it to individuals with schizophrenia.

Occupational therapy standard care

Behavioral

Occupational therapy standard care

Primary outcomes

  1. Positive and Negative Syndrome Scale

    Time frame: 15 minutes

    The Positive and Negative Syndrome Scale is a 30-item scale with seven positive and seven negative symptoms items and 16 psychopathological items. The severity of each item is rated on a scale from 1 (none) to 7 (most severe). A general Positive and Negative Syndrome Scale score is between 30 (lack of symptoms) and 210 (very severe state of the disease). Potential ranges are 7 to 49 for the positive and negative symptom scales and from 16 to 12 for the general psychopathology scale.

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Registry information

Official study title

Development and Efficacy of Metacognitive Intervention for Individuals With Severe Mental Disorders

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 27, 2022
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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