Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ChiCTR |
Last refreshed on:
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18 April 2017 |
Main ID: |
ChiCTR-IOR-15007166 |
Date of registration:
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2015-09-30 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Attributions andemotions – investigation of the transdiagnostic relationship anda randomized controlled trial on the effect of 4-session metacognitive training in Chinese adult outpatients with schizophrenia spectrum disorders andmajor depressive disorder
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Scientific title:
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Attributions andemotions – investigation of the transdiagnostic relationship anda randomized controlled trial on the effect of 4-session metacognitive training in Chinese adult outpatients with schizophrenia spectrum disorders andmajor depressive disorder |
Date of first enrolment:
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2015-10-06 |
Target sample size:
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Two groups:180;Description of the treatment:0;(to be continued):0;(to be continued):0;(to be continued):0;(to be continued):0; |
Recruitment status: |
Pending |
URL:
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http://www.chictr.org.cn/showproj.aspx?proj=12059 |
Study type:
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Interventional study |
Study design:
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Randomized parallel controlled trial
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Phase:
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Other
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Countries of recruitment
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China
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Contacts
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Name:
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Wong Hau Lam
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Address:
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Room 320, 3/F, Department of Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong
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Telephone:
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+852 39436472 |
Email:
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hlwong@psy.cuhk.edu.hk |
Affiliation:
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Department of Psychology, The Chinese University of Hong Kong |
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Name:
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Prof. So Ho-wai Suzanne
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Address:
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Room 321, Department of Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong
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Telephone:
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+852 39436211 |
Email:
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shwso@psy.cuhk.edu.hk |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Delusion group: non-organic psychosis with active delusions.
Depression group: major depressive disorder, received treatment for at least 1 month, with active depressive symptoms (moderate depression, with BDI-II score around 20 or above).
Exclusion criteria: Psychotic depression;
Depression with psychotic features;
Bipolar disorder;
Primary diagnosis of substance misuse;
Learning disability;
Participation in any cognitive/ reasoning training program.
Age minimum:
18
Age maximum:
65
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Psychosis, Depression
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Intervention(s)
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Two groups:4-session Metacognitive training (MCT) once a week for four weeks versus Treatment as usual (TAU);Description of the treatment:1. Treatment condition - 4 weeks of Metacognitive training (MCT) in groups of 6-8 members, with training targetting at reasoning bias relevant to those observed in depression andpsychosis. The attribution training will consist of 4 sessions from the Chinese MCT protocol: module 1 (“Attributions”), module 3 (“Changing beliefs”), module 4 (“To empathise”) andmodule 8 (“Self-esteem andmood”). ;(to be continued):Module 1 specifically targets internal andexternal attributions in both positive andnegative events, andexplicitly links these to both depression anddelusions. Modules 3 and4 challenge ‘first impressions’ andfocus on the importance of considering evidence that does not support one’s original beliefs. ;(to be continued):Module 8 educates patients about depressive cognition – including internalising bias andselective attention, etc. – andtheir link to low mood andself-esteem. Therapeutic exercises in this module draw from the positive psychology approaches, namely optimism, positive attention andmemory, andthanksgiving.;(to be continued):2. Treatment as usual (TAU) condition - 4 weeks of standard care (psychiatric follow-up andpharmacological intervention) from their psychiatric clinics. Patients on the TAU condition will not be receiving any psychological treatment concurrently. ;(to be continued):Assessments will take place before TAU, after 4 weeks of TAU, with follow-ups after 1 and6 months.;
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Primary Outcome(s)
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Attributional style, measured by 1. Internal, Personal andSituational Attributions Questionnaire; 2. Attributional Style Questionnaire; 3. Daily diary method for 7 days; 4. Personal significance scale (PSS);Symptomatology for psychotic group measured by 1. Positive andNegative Syndrome Scale; 2. The Psychotic Symptom Rating Scale; 3. Calgary Depression Scale; 4. Generalised Anxiety Disorder 7;Symptomatology for depression group, measured by 1. Beck Depression Inventory – II; 2. Generalised Anxiety Disorder 7;Belief Flexibility, measured by 1. Maudsley Assessment of Delusions Schedule; 2. Explanation of Experience; 3. BADE task.;Emotional states (Depression, Anger, Anxiety), measured by State-Trait Personality Inventory;
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Secondary Outcome(s)
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Executive functioning measured by Trail making test (TMT);Intellectual functioning measured by Wechsler Adult Intelligence Scale (WAIS)-III Chinese version;Psychiatric diagnosis measured by Structured Clinical Interview for DSM.;
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Secondary ID(s)
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CUHK_CCRB00480
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Source(s) of Monetary Support
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Non-commerical funding source: Croucher Foundation
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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