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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
Scientific title
The effectiveness of a Brief-ASSIST Linked Brief Intervention (BI) for the treatment of substance abuse among schizophrenic patients
Secondary ID [1] 281323 0
Nil
Universal Trial Number (UTN)
U1111-1135-2705
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 287538 0
Substance abuse 287539 0
Condition category
Condition code
Mental Health 287863 287863 0 0
Schizophrenia
Mental Health 287864 287864 0 0
Addiction

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 285787 0
Treatment: Other
Intervention code [2] 285806 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 288085 0
mean Brief ASSIST score
Timepoint [1] 288085 0
Baseline, and at 3 and 6 months after intervention commencement
Primary outcome [2] 288086 0
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)
Timepoint [2] 288086 0
Baseline, and at 3 and 6 months after intervention commencement
Primary outcome [3] 288087 0
The process of change and readiness to change substance using behavior as assessed using a Stages of Change Readiness and Treatment Eagerness Scale (SOCRATE)
Timepoint [3] 288087 0
Baseline, and at 3 and 6 months after intervention commencement
Secondary outcome [1] 299397 0
Substance related problems as assessed using an Addiction Severity Index (ASI)
Timepoint [1] 299397 0
Baseline, and at 3 and 6 months after intervention commencement
Secondary outcome [2] 299398 0
Emotional and behavioral symptoms as assessed using a Brief Psychiatric Rating Scale (BPRS)
Timepoint [2] 299398 0
Baseline, and at 3 and 6 months after intervention commencement
Secondary outcome [3] 299399 0
Functional status as assessed using a Global Assessment of Functioning scale (GAF)
Timepoint [3] 299399 0
Baseline, and at 3 and 6 months after intervention commencement
Secondary outcome [4] 299400 0
Family functional status as assessed using a Global Assessment of Relational Functioning scale (GARF)
Timepoint [4] 299400 0
Baseline, and at 3 and 6 months after intervention commencement

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 4577 0
Thailand
State/province [1] 4577 0
Songkhla

Funding & Sponsors
Funding source category [1] 286087 0
Government body
Name [1] 286087 0
Integrated Management for Alcohol Intervention Program (I-MAP)
Country [1] 286087 0
Thailand
Primary sponsor type
University
Name
Prince of Songkhla University
Address
Epidemiology Unit, Faculty of Medicine
Prince of Songkla University
15 Kanjanawanich Rd.
Hadyai District
Songkhla Province
90110
Country
Thailand
Secondary sponsor category [1] 284901 0
Hospital
Name [1] 284901 0
Songkhla Rajanagarind Psychiatric Hospital
Address [1] 284901 0
472 Zhaiburi Rd.
Boyang Sub-District
Muang District
Songkhla Province
90000
Country [1] 284901 0
Thailand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288140 0
Faculty of Medicine, Prince of songkla University
Ethics committee address [1] 288140 0
Ethics committee country [1] 288140 0
Thailand
Date submitted for ethics approval [1] 288140 0
Approval date [1] 288140 0
18/05/2012
Ethics approval number [1] 288140 0
55-222-18-5-2
Ethics committee name [2] 288141 0
The Ethical Review Committee for Research in Human Subjects. Songkhla Rajanagarind Psychiatric Hospital
Ethics committee address [2] 288141 0
Ethics committee country [2] 288141 0
Thailand
Date submitted for ethics approval [2] 288141 0
Approval date [2] 288141 0
25/04/2012
Ethics approval number [2] 288141 0
15/2554

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34776 0
Address 34776 0
Country 34776 0
Phone 34776 0
Fax 34776 0
Email 34776 0
Contact person for public queries
Name 18023 0
Nopporn Tantirangsee
Address 18023 0
Songkhla Rajanagarind Psychiatric Hospital
472 Zhaiburi Rd.
Boyang Sub-District
Muang District
Songkhla Province
90000
Country 18023 0
Thailand
Phone 18023 0
+66849990662
Fax 18023 0
+6674323202
Email 18023 0
nopporntan@hotmail.com
Contact person for scientific queries
Name 8951 0
Nopporn Tantirangsee
Address 8951 0
Songkhla Rajanagarind Psychiatric Hospital
472 Zhaiburi Rd.
Boyang Sub-District
Muang District
Songkhla Province
90000
Country 8951 0
Thailand
Phone 8951 0
+66849990662
Fax 8951 0
+6674323202
Email 8951 0
nopporntan@hotmail.com

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.