Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00480

2 Trial Registration Date

2015-09-30

i Registration Status

Prospective

3 Secondary IDs

CREC-2014.031

4 Source(s) of Funding

Non-commerical funding source: Croucher Foundation

5 Primary Sponsor

Department of Psychology, The Chinese University of Hong Kong

6 Secondary Sponsor

Not Applicable

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Wong Hau Lam

ii Address

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

iii Phone

39436472

iv Email

hlwong@psy.cuhk.edu.hk

v Affiliation

Department of Psychology, The Chinese University of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. So Ho-wai Suzanne

ii Address

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

iii Phone

39436211

iv Email

shwso@psy.cuhk.edu.hk

v Affiliation

Department of Psychology, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

思考模式與情感的關係研究

11 Short Title (Optional)

Attributions and emotions

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-03-31

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC-2014.031

14 Medical Condition Being Studied

Psychosis

Depression

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

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

iii Dosage form of the intervention

Group sessions

iv Dosage of the intervention

4

v Duration of the intervention

4 weeks

vi Frequency of the intervention

once a week

16 Comparative Treatments

i Description/ name of comparative treatments

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.

ii Dosage form of the comparative treatments

Treatment as usual (TAU)

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

4 weeks

v Frequency of the comparative treatments

4 weeks

17 Key Inclusion and Exclusion Criteria

i 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)

ii Exclusion Criteria

Psychotic depression

Depression with psychotic features

Bipolar disorder

Primary diagnosis of substance misuse

Learning disability

Participation in any cognitive/ reasoning training program

iii Age Minimum

18

iv Age Maximum

65

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Randomised controlled trial (RCT)

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

0

Please specify

vi Study Objectives (Optional)

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.

20 Anticipated trial start date

2015-10-06

21 Target Sample Size

180

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Attributional style

ii The metric or method of measurement used

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)

iii The timepoint(s) of primary interest

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

Primary Outcome

i The Name of the outcome

Symptomatology for psychotic group

ii The metric or method of measurement used

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)

iii The timepoint(s) of primary interest

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

Primary Outcome

i The Name of the outcome

Symptomatology for depression group

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

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

Primary Outcome

i The Name of the outcome

Belief Flexibility

ii The metric or method of measurement used

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)

iii The timepoint(s) of primary interest

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

Primary Outcome

i The Name of the outcome

Emotional states (Depression, Anger, Anxiety)

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

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

24 Secondary Outcome

i The Name of the outcome

Executive functioning

ii The metric or method of measurement used

Trail making test (TMT)

iii The timepoint(s) of primary interest

Pre assessment

Secondary Outcome

i The Name of the outcome

Intellectual functioning

ii The metric or method of measurement used

Wechsler Adult Intelligence Scale (WAIS)-III Chinese version

iii The timepoint(s) of primary interest

Pre assessment

Secondary Outcome

i The Name of the outcome

Psychiatric diagnosis

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

Pre assessment

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-04-05

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-15007166

28 Date of Registration in Primary Registry

2015-09-30

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