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CompletedNCT03449394Updated Jan 23, 2020

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

An interventional study of Metacognitive Training in Delusions and Depression, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-01-23.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
113
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Delusions
  • Depression

Keywords

  • Psychosis
  • Depression
  • Metacognition
  • Attribution
  • Emotions
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
113 participants (actual)

Study arms

  • Active comparator
    Delusions (Tx)

    Other: Metacognitive Training

  • No intervention
    Delusions (TAU)
  • Active comparator
    Depression (Tx)

    Other: Metacognitive Training

  • No intervention
    Depression (TAU)

Interventions

  • OtherMetacognitive Training

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

05

What researchers measure

Primary outcomes

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

    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.

    Time frame: 6 months

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

    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.

    Time frame: 6 months

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

    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.

    Time frame: 6 months

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

    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.

    Time frame: 6 months

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

    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.

    Time frame: 6 months

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

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

    Time frame: 6 months

Secondary outcomes

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

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

    Time frame: Baseline

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

    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.

    Time frame: 6 months

06

Study locations

1 site
  • Chinese University of Hong Kong
    Hong Kong, Hong Kong
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03449394
Lead sponsor
Chinese University of Hong Kong
Responsible party
Suzanne Ho-wai So (Assistant Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Feb 28, 2018
Start date
Apr 2015
Primary completion
Nov 2019
Completion
Nov 2019
Last update
Jan 23, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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