DelusionsNCT03449394
Effect of 4-session Metacognitive Training in Chinese Adult Outpatients With Schizophrenia Spectrum Disorders and Major Depressive Disorder
A study testing Metacognitive Training in people with Delusions and Depression, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Delusions, Depression
- What is being tested?
- Metacognitive Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteHong Kong
- Study dates
- Apr 2015to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- Clinical diagnosis of non-organic psychosis or major depressive disorder
- Presentation of delusions/a moderate level of depression
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Metacognitive Training
- Keywords
- Psychosis, Depression, Metacognition, Attribution, Emotions
- Medical subject headings
- Delusions, Depression, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive TrainingOther
4 sessions of Metacognitive Training using 4 treatment modules each targeting different cognitive biases
| Study group | Role | What they receive |
|---|---|---|
| Delusions (Tx) | Active comparator | Not described Receives: Other: Metacognitive Training |
| Delusions (TAU) | No intervention | Not described |
| Depression (Tx) | Active comparator | Not described Receives: Other: Metacognitive Training |
| Depression (TAU) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study startApr 2015
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DelusionsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne Ho-wai So, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449394
- Sponsor's protocol ID
- MCT2.0
- Status last verified
- Jan 2020
- First submitted
- 23 Jan 2018
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 4-session Metacognitive Training in Chinese Adult Outpatients With Schizophrenia Spectrum Disorders and Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03449394
- Acronym / sponsor ID
- MCT2.0
- Conditions
- Delusions, Depression
- Keywords
- Psychosis, Depression, Metacognition, Attribution, Emotions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Delusions (Tx) | Active comparator | Other: Metacognitive Training |
| Delusions (TAU) | No intervention | – |
| Depression (Tx) | Active comparator | Other: Metacognitive Training |
| Depression (TAU) | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-65 years
- Clinical diagnosis of non-organic psychosis or major depressive disorder
- Presentation of delusions/a moderate level of depression
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive Training4 sessions of Metacognitive Training using 4 treatment modules each targeting different cognitive biases | Other | Delusions (Tx), Depression (Tx) |
Primary outcome
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Cognitive capacity as measured by the Chinese version of the Wechsler Adult Intelligence Scale - III (WAIS-III)
Time frame: Baseline
Severity of generalized anxiety disorder as measured by Generalised Anxiety Disorder 7 (GAD-7)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Training in people with Delusions and Depression, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attributional style as measured by the Internal, Personal and Situational Attributions Questionnaire (IPSAQ) (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.