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Trial History Detail on 2015-09-30

CUHK_CCRB00480

2015-09-30

Prospective

CREC-2014.031

Non-commerical funding source: Croucher Foundation

Department of Psychology, The Chinese University of Hong Kong

Not Applicable

Not Applicable

Wong Hau Lam

Room 320, 3/F, Department of Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong

39436472

hlwong@psy.cuhk.edu.hk

Department of Psychology, The Chinese University of Hong Kong

Hong Kong

Prof. So Ho-wai Suzanne

Room 321, Department of Psychology, The Chinese University of Hong Kong, Shatin, Hong Kong

39436211

shwso@psy.cuhk.edu.hk

Department of Psychology, The Chinese University of Hong Kong

Hong Kong

Attributions and emotions – investigation of the transdiagnostic relationship and a randomized controlled trial on the effect of 4-session metacognitive training in Chinese adult outpatients with schizophrenia spectrum disorders and major depressive disorder

Attributions and emotions – investigation of the transdiagnostic relationship and a randomized controlled trial on the effect of 4-session metacognitive training in Chinese adult outpatients with schizophrenia spectrum disorders and major depressive disorder

思考模式與情感的關係研究

Attributions and emotions

Hong Kong

Yes

2014-03-31

Joint CUHK-NTEC Clinical Research Ethics Committee

CREC-2014.031

Psychosis

Depression

Behavior

4-session Metacognitive training (MCT) for Chinese outpatients with schizophrenia spectrum disorders and major depressive disorder

Group sessions

4

4 weeks

once a week

Participants will be randomly assigned to either:

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 and psychosis. The attribution training will consist of 4 sessions from the Chinese MCT protocol: module 1 (“Attributions”), module 3 (“Changing beliefs”), module 4 (“To empathise”) and module 8 (“Self-esteem and mood”). Module 1 specifically targets internal and external attributions in both positive and negative events, and explicitly links these to both depression and delusions. Modules 3 and 4 challenge ‘first impressions’ and focus on the importance of considering evidence that does not support one’s original beliefs. Module 8 educates patients about depressive cognition – including internalising bias and selective attention, etc. – and their link to low mood and self-esteem. Therapeutic exercises in this module draw from the positive psychology approaches, namely optimism, positive attention and memory, and thanksgiving.

2. Treatment as usual (TAU) condition - 4 weeks of standard care (psychiatric follow-up and pharmacological intervention) from their psychiatric clinics. Patients on the TAU condition will not be receiving any psychological treatment concurrently.

Assessments will take place before TAU, after 4 weeks of TAU, with follow-ups after 1 and 6 months.

Treatment as usual (TAU)

N/A

4 weeks

4 weeks

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)

Psychotic depression

Depression with psychotic features

Bipolar disorder

Primary diagnosis of substance misuse

Learning disability

Participation in any cognitive/ reasoning training program

18

65

Both Male and Female

Interventional

Randomized

Randomised controlled trial (RCT)

Not Applicable

Open label

Parallel

0

This study aims to provide an alternative to the traditional disorder-based approach of aetiological studies, and examine the use of a process-based model to understand commonalities across disorders.

2015-10-06

180

Not Yet Recruiting

Attributional style

1. Internal, Personal and Situational Attributions Questionnaire (IPSAQ; Kinderman & Bentall, 1996); 2. Attributional Style Questionnaire (ASQ; Peterson et al, 1982); 3. Daily diary method for 7 days; 4. Personal significance scale (PSS)

Pre, Post- assessment, 1-month and 6-month follow ups (Apart from ASQ & PSS, which will only be measured at pre assessment)

Symptomatology for psychotic group

1. Positive and Negative Syndrome Scale (PANSS; Kay et al. 1987); 2. The Psychotic Symptom Rating Scale (PSYRATS; Haddock et al., 1999); 3. Calgary Depression Scale (CDS; Addington et al, 1992); 4. Generalised Anxiety Disorder 7 (GAD-7; Spitzer et al, 2006)

Pre, Post- assessment,1-month and 6-month follow ups

Symptomatology for depression group

1. Beck Depression Inventory – II (BDI-II; Beck et al., 1996), 2. Generalised Anxiety Disorder 7 (GAD-7; Spitzer et al, 2006)

Pre, Post- assessment,1-month and 6-month follow ups

Belief Flexibility

1. Maudsley Assessment of Delusions Schedule (MADS; Wessely et al., 1993); 2. Explanation of Experience (EoE; Freeman et al, 2004); 3. BADE task (Woodward et al., 2006)

Pre, Post- assessment,1-month and 6-month follow ups

Emotional states (Depression, Anger, Anxiety)

State-Trait Personality Inventory (STPI; Spielberger & Krasner, 1988)

Pre, Post- assessment,1-month and 6-month follow ups

Executive functioning

Trail making test (TMT)

Pre assessment

Intellectual functioning

Wechsler Adult Intelligence Scale (WAIS)-III Chinese version

Pre assessment

Psychiatric diagnosis

Structured Clinical Interview for DSM (CB-SCID-I/P; So et al, 2003)

Pre assessment

No

2016-04-05

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