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Trial registered on ANZCTR
Registration number
ACTRN12612001059853
Ethics application status
Approved
Date submitted
30/09/2012
Date registered
4/10/2012
Date last updated
5/10/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effectiveness of Brief-Alcohol, Smoking, Substance Involvement Screening Test (Brief-ASSIST) – Linked Brief Intervention (BI) for substance abuse among schizophrenic patients
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Scientific title
The effectiveness of a Brief-ASSIST Linked Brief Intervention (BI) for the treatment of substance abuse among schizophrenic patients
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Secondary ID [1]
281323
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Nil
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Universal Trial Number (UTN)
U1111-1135-2705
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Schizophrenia
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Substance abuse
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Condition category
Condition code
Mental Health
287863
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0
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Schizophrenia
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Mental Health
287864
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0
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Addiction
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arm 1: Brief Intervention = 1 session (1 hour/session) of motivational interview + Goal setting + Relapse prevention
(The intervention is one-on-one therapy with a psychiatric nurse).
Arm 2: Brief Intervention + Family Session = Brief Intervention plus 1 session (30 minutes/session) of family psychoeducation (The intervention is one-on-one therapy with a psychiatric nurse).
More explaination about Brief ASSIST linked Brief Intervention:
The brief-ASSIST scores can divide the clients into three categories including low, moderate and high risk categories and the brief-ASSIST has its specific brief intervention for the clients in moderate risk category (no intervention for low risk category and more intensive intervention for high risk category).
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Intervention code [1]
285787
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Treatment: Other
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Intervention code [2]
285806
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Behaviour
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Comparator / control treatment
Standard treatment:
The participants will receive all of standard psychiatric care from the hospital such as psychiatric drug and psychoeducation about schizophrenic symptoms and medication side effect. Then, they will be treated with brief advice about the bad effect of such substance and give the general advice to stop using substance such as do more exercise, play the music, and eat good food.
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Control group
Active
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Outcomes
Primary outcome [1]
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mean Brief ASSIST score
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Assessment method [1]
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Timepoint [1]
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Baseline, and at 3 and 6 months after intervention commencement
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Primary outcome [2]
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The days of substance use and the amounts of substance use in each day in past three month as assessed using a Timeline Followback (a calendar style evaluation form)
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Assessment method [2]
288086
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Timepoint [2]
288086
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Baseline, and at 3 and 6 months after intervention commencement
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Primary outcome [3]
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The process of change and readiness to change substance using behavior as assessed using a Stages of Change Readiness and Treatment Eagerness Scale (SOCRATE)
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Assessment method [3]
288087
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Timepoint [3]
288087
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Baseline, and at 3 and 6 months after intervention commencement
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Secondary outcome [1]
299397
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Substance related problems as assessed using an Addiction Severity Index (ASI)
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Assessment method [1]
299397
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Timepoint [1]
299397
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Baseline, and at 3 and 6 months after intervention commencement
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Secondary outcome [2]
299398
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Emotional and behavioral symptoms as assessed using a Brief Psychiatric Rating Scale (BPRS)
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Assessment method [2]
299398
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Timepoint [2]
299398
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Baseline, and at 3 and 6 months after intervention commencement
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Secondary outcome [3]
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Functional status as assessed using a Global Assessment of Functioning scale (GAF)
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Assessment method [3]
299399
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Timepoint [3]
299399
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Baseline, and at 3 and 6 months after intervention commencement
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Secondary outcome [4]
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Family functional status as assessed using a Global Assessment of Relational Functioning scale (GARF)
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Assessment method [4]
299400
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Timepoint [4]
299400
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Baseline, and at 3 and 6 months after intervention commencement
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Eligibility
Key inclusion criteria
1.Patients met the ICD-10 criteria of schizophrenia (F20), Acute & transient psychotic disorders (F23) & Unspecified nonorganic psychosis (F29) diagnosed by psychiatrists
2.Those whose score at the moderate-risk Brief-ASSIST level 3.Understand and can speak Thai
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1.Communication difficulties or cognitive impairment
2.Severe behavioral disturbances
3.Comorbid organic disorder and/or mental retardation
4.Drug and alcohol intoxication or severe withdrawal
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
2/07/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
4577
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Thailand
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State/province [1]
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Songkhla
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Integrated Management for Alcohol Intervention Program (I-MAP)
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Address [1]
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Floor 2, Rehabilitation Building, Suanprung Hospital
131 Changlor Rd.
Haiya Sub-District
Muang District
Chiangmai Province
50100
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Country [1]
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Thailand
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Primary sponsor type
University
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Name
Prince of Songkhla University
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Address
Epidemiology Unit, Faculty of Medicine
Prince of Songkla University
15 Kanjanawanich Rd.
Hadyai District
Songkhla Province
90110
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Country
Thailand
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Songkhla Rajanagarind Psychiatric Hospital
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Address [1]
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472 Zhaiburi Rd.
Boyang Sub-District
Muang District
Songkhla Province
90000
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Country [1]
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Thailand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288140
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Faculty of Medicine, Prince of songkla University
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Ethics committee address [1]
288140
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15 Kanjanawanich Rd.
Hadyai District
Songkhla Province
90110
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Ethics committee country [1]
288140
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Thailand
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Date submitted for ethics approval [1]
288140
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Approval date [1]
288140
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18/05/2012
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Ethics approval number [1]
288140
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55-222-18-5-2
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Ethics committee name [2]
288141
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The Ethical Review Committee for Research in Human Subjects. Songkhla Rajanagarind Psychiatric Hospital
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Ethics committee address [2]
288141
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472 Zhaiburi Rd.
Boyang Sub-District
Muang District
Songkhla Province
90000
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Ethics committee country [2]
288141
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Thailand
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Date submitted for ethics approval [2]
288141
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Approval date [2]
288141
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25/04/2012
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Ethics approval number [2]
288141
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15/2554
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Summary
Brief summary
Study objective:
To study the effectiveness of the Brief-Alcohol, Smoking, Substance Involvement Screening Test (Brief-ASSIST) – Linked Brief Intervention for substance abuse among schizophrenic patients.
Study hypothesis:
This early intervention is expected to help decrease disease burden related with schizophrenia and substance use disorder
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Nopporn Tantirangsee
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Address
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Songkhla Rajanagarind Psychiatric Hospital
472 Zhaiburi Rd.
Boyang Sub-District
Muang District
Songkhla Province
90000
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Country
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Thailand
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Phone
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+66849990662
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Fax
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+6674323202
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Email
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[email protected]
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Contact person for scientific queries
Name
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Nopporn Tantirangsee
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Address
8951
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Songkhla Rajanagarind Psychiatric Hospital
472 Zhaiburi Rd.
Boyang Sub-District
Muang District
Songkhla Province
90000
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Country
8951
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Thailand
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Phone
8951
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+66849990662
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Fax
8951
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+6674323202
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Email
8951
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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