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Completed

NCT Number: NCT03449394

Effect of 4-session Metacognitive Training in Chinese Adult Outpatients With Schizophrenia Spectrum Disorders and Major Depressive Disorder

Psychological studies have shown that individuals tend to attribute causes of positive and negative events differently. Specifically, individuals hold an internalising or externalising bias of attribution which, in the case of particular patient groups, was found to polarize to the extreme. Such extreme attributional styles have found to have a direct impact on emotions, leading to a waning course of psychiatric disorders. This project aims to further examine the theoretical links between attributions and emotions using a transdiagnostic approach, and the effect of a 4-session process-based intervention on attributional biases.

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Key information

Conditions

Delusions Behavior Behavioral Symptoms Depression Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese University of Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18-65 years
  • Clinical diagnosis of non-organic psychosis or major depressive disorder
  • Presentation of delusions/a moderate level of depression

Exclusion criteria

  • Clinical diagnosis of psychotic depression or depression with psychotic features
  • Primary diagnosis of substance misuse or learning disability
  • Participation of any cognitive/reasoning training program

Treatment and study plan

Metacognitive Training

Other

4 sessions of Metacognitive Training using 4 treatment modules each targeting different cognitive biases

Primary outcomes

  1. Attributional style as measured by the Internal, Personal and Situational Attributions Questionnaire (IPSAQ)

    Time frame: 6 months

    IPSAQ consists of hypothetical scenarios. Participants are required to think of a single, most likely causal explanation to each of the hypothesized situations, and then to categorize this cause as being internal, external-personal or external-situational.

  2. Psychotic symptomatology as measured by Positive and Negative Syndrome Scale (PANSS)

    Time frame: 6 months

    Positive and Negative Syndrome Scale (PANSS) is an interview-based assessment of the severity of symptoms associated with schizophrenia, including positive, negative, and general psychopathology.

  3. Depressive symptomatology as measured by Beck Depression Inventory - II (BDI-II) and Calgary Depression Scale (CDS)

    Time frame: 6 months

    Beck Depression Inventory - II (BDI-II) is a 21-item self-report inventory that assesses symptoms of depression. Scores can range from 0 to 63, with higher scores reflecting greater symptom severity. Calgary Depression Scale (CDS) is a nine-item structured interview scale that assesses depressive symptoms in patients with schizophrenia.

  4. Conviction of beliefs as measured by the Psychotic Symptom Rating Scale (PSYRATS)

    Time frame: 6 months

    The Psychotic Symptom Rating Scale (PSYRATS) is a 17-item semi-structured interview measuring the severity of multiple dimensions of auditory hallucinations and delusions, including conviction and duration.

  5. Belief flexibility as measured by Maudsley Assessment of Delusions Schedule (MADS) and the BADE task

    Time frame: 6 months

    Maudsley Assessment of Delusions Schedule (MADS) is a standardised interview assessment that records whether participants could consider possibility of being mistaken (PM) about their delusional experience, any possible alternative explanations for the experience (EoE), and their reaction to hypothetical contradiction (RTHC). BADE task is an experimental design for measuring participants' bias against disconfirmatory evidence.

  6. State-trait personality as measured by the State-Trait Personality Inventory (STPI)

    Time frame: 6 months

    State-Trait Personality Inventory (STPI) consists of 8 self-report scales, each containing 10 items covering state and trait anger, anxiety, curiosity and depression.

Secondary outcomes

  1. Cognitive capacity as measured by the Chinese version of the Wechsler Adult Intelligence Scale - III (WAIS-III)

    Time frame: Baseline

    Three subtest short form - vocabulary, matrix reasoning and information - will be administered at baseline to assess the participants' cognitive capacity.

  2. Severity of generalized anxiety disorder as measured by Generalised Anxiety Disorder 7 (GAD-7)

    Time frame: 6 months

    Generalised Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for screening and assessing severity of generalised anxiety disorder (GAD). This scale consists of seven items that measure severity of various signs of GAD according to reported response categories.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2018
Registry last updated
Jan 23, 2020

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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