Metacognitive training: a randomized controlled trial to evaluate efficacy and cost-effectiveness of a training that aims to change cognitive biases that perpetuate psychosis in people with paranoid schizophrenia

Metacognitive training: a randomized controlled trial to evaluate efficacy and cost-effectiveness of a training that aims to change cognitive biases that perpetuate psychosis in people with paranoid schizophrenia - Metacognitive training: a randomized controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35242

Enrollment

180

Registered

2010-04-06

Start date

2010-04-07

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

delusions psychosis

Interventions

MCT is a group intervention intended for 3-10 patients. Sessions are typically conducted either by a clinical psychologist, psychiatrist, occupational therapist or psychiatric nurse. Each of the eig

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -patients with schizophrenia and/or another psychotic disorder (established with SCAN) -With delusional symptoms (established with PANNS, PSYRATS and GPTS) -age between 18-65

Exclusion criteria

Exclusion criteria: -primairy addiction -insufficient understanding of the dutch language -IQ

Design outcomes

Primary

Measure	Time frame
Primary outcomes: The GPTS was chosen as primary outcome. The GPTS is a questionnaire that measures paranoid ideas and ideas of social reference with 32 items on a 5-point Likert-scale. The internal consistency is good, with a Crohnbach alpha > 0.70 and the test is consider valid.	—

Secondary

Measure	Time frame
Secondary outcomes: The EQ-5D is a standardized measure of health status developed by the EuroQoL Group in order to provide a simple, generic measure of health for clinical and economic appraisal. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys [25]. The Davos Assessment of Cognitive Bias Scale (DACOBS) [26] is a questionnaire thath measures the subjective experience of cognitive bias using 42 items on a 7-point Likert-scale. The following cognitive biases are measured: the jumping-to-conclusions bias, dogmatism bias, slective attention bias and the self-as-target bias. In addition, there are questions regarding cognitive limitations and safety behaviors. The psychometric qualities of this questionnaire are currently being investigated. The Beck Cognitive Insight Scale (BCIS) [18] is a 15-item self-report scale measuring 2 constructs: the ability to acknowledge fallibility, labeled self-reflectiveness and certainty about belief and judgments, labeled self-certainty. A composite score reflecting cognitive insight is calculated by subtracting the self-certainty scale from the self-reflectiveness scale. The BCIS has demonstrated good convergent, discriminant, and construct validity with inpatients. The PSYRATS DRS [23] is a semi-structured interview whichs measures qualitative and quantitative aspects of delusions. The Metacognitions Questionnaire 30 (MCQ30) [27] is a questionnaire that measures metacognitions via 30 items on a 4-point Likert-scale. The manual distinguishes between cognitive self-confidence, positive views, cognitive self-awareness, uncontrollability and danger and need-for-control. The Beads Task [28] is used to measure the tendency to jump to conclusions. In the beads task, participants are shown two jars of coloured	—

Measure

Time frame

Secondary outcomes: The EQ-5D is a standardized measure of health status developed by the EuroQoL Group in order to provide a simple, generic measure of health for clinical and economic appraisal. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys [25]. The Davos Assessment of Cognitive Bias Scale (DACOBS) [26] is a questionnaire thath measures the subjective experience of cognitive bias using 42 items on a 7-point Likert-scale. The following cognitive biases are measured: the jumping-to-conclusions bias, dogmatism bias, slective attention bias and the self-as-target bias. In addition, there are questions regarding cognitive limitations and safety behaviors. The psychometric qualities of this questionnaire are currently being investigated. The Beck Cognitive Insight Scale (BCIS) [18] is a 15-item self-report scale measuring 2 constructs: the ability to acknowledge fallibility, labeled self-reflectiveness and certainty about belief and judgments, labeled self-certainty. A composite score reflecting cognitive insight is calculated by subtracting the self-certainty scale from the self-reflectiveness scale. The BCIS has demonstrated good convergent, discriminant, and construct validity with inpatients. The PSYRATS DRS [23] is a semi-structured interview whichs measures qualitative and quantitative aspects of delusions. The Metacognitions Questionnaire 30 (MCQ30) [27] is a questionnaire that measures metacognitions via 30 items on a 4-point Likert-scale. The manual distinguishes between cognitive self-confidence, positive views, cognitive self-awareness, uncontrollability and danger and need-for-control. The Beads Task [28] is used to measure the tendency to jump to conclusions. In the beads task, participants are shown two jars of coloured

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)