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

Primary Purpose

Delusions, Depression

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Metacognitive Training
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delusions focused on measuring Psychosis, Depression, Metacognition, Attribution, Emotions

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Active Comparator

No Intervention

Arm Label

Delusions (Tx)

Delusions (TAU)

Depression (Tx)

Depression (TAU)

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 23, 2018
Last Updated
January 22, 2020
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03449394
Brief Title
Effect of 4-session Metacognitive Training in Chinese Adult Outpatients With Schizophrenia Spectrum Disorders and Major Depressive Disorder
Official Title
Effect of 4-session Metacognitive Training in Chinese Adult Outpatients With Schizophrenia Spectrum Disorders and Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delusions, Depression
Keywords
Psychosis, Depression, Metacognition, Attribution, Emotions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Delusions (Tx)
Arm Type
Active Comparator
Arm Title
Delusions (TAU)
Arm Type
No Intervention
Arm Title
Depression (Tx)
Arm Type
Active Comparator
Arm Title
Depression (TAU)
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Metacognitive Training
Intervention Description
4 sessions of Metacognitive Training using 4 treatment modules each targeting different cognitive biases
Primary Outcome Measure Information:
Title
Attributional style as measured by the Internal, Personal and Situational Attributions Questionnaire (IPSAQ)
Description
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
Title
Psychotic symptomatology as measured by Positive and Negative Syndrome Scale (PANSS)
Description
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
Title
Depressive symptomatology as measured by Beck Depression Inventory - II (BDI-II) and Calgary Depression Scale (CDS)
Description
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
Title
Conviction of beliefs as measured by the Psychotic Symptom Rating Scale (PSYRATS)
Description
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
Title
Belief flexibility as measured by Maudsley Assessment of Delusions Schedule (MADS) and the BADE task
Description
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
Title
State-trait personality as measured by the State-Trait Personality Inventory (STPI)
Description
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 Outcome Measure Information:
Title
Cognitive capacity as measured by the Chinese version of the Wechsler Adult Intelligence Scale - III (WAIS-III)
Description
Three subtest short form - vocabulary, matrix reasoning and information - will be administered at baseline to assess the participants' cognitive capacity.
Time Frame
Baseline
Title
Severity of generalized anxiety disorder as measured by Generalised Anxiety Disorder 7 (GAD-7)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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