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

NCT03449394 | Completed

• 1 other identifier: MCT2.0
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Delusions; Depression

Keywords

Psychosis; Depression; Metacognition; Attribution; Emotions

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

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

  Baseline

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

  6 months

Study Arms (4)

Delusions (Tx)

ACTIVE COMPARATOR

Other: Metacognitive Training

Delusions (TAU)

NO INTERVENTION

Depression (Tx)

ACTIVE COMPARATOR

Other: Metacognitive Training

Depression (TAU)

NO INTERVENTION

Interventions

Metacognitive Training OTHER

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

Delusions (Tx); Depression (Tx)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Delusions; Depression; Psychotic Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 28, 2018
• Study Start: April 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)