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.

Study Overview

• Status: Completed
• Conditions: Depression; Delusions
• Intervention / Treatment: Other: Metacognitive Training

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Delusions (Tx)	Other: Metacognitive Training; 4 sessions of Metacognitive Training using 4 treatment modules each targeting different cognitive biases
No Intervention: Delusions (TAU)
Active Comparator: Depression (Tx)	Other: Metacognitive Training; 4 sessions of Metacognitive Training using 4 treatment modules each targeting different cognitive biases
No Intervention: Depression (TAU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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.	6 months
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.	6 months
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.	6 months
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.	6 months
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	6 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Depression; Psychosis; Emotions; Metacognition; Attribution
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Depression; Depressive Disorder; Schizophrenia; Depressive Disorder, Major; Delusions
• Other Study ID Numbers: MCT2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No