Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000618954
Ethics application status
Approved
Date submitted
27/05/2011
Date registered
16/06/2011
Date last updated
23/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Enhancing residential substance abuse treatment with computer interventions
Scientific title
A randomised trial of a computer-based depression intervention for individuals attending a residential substance abuse program.
Secondary ID [1] 259965 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol and substance abuse 267969 0
Depression 267970 0
Condition category
Condition code
Mental Health 268100 268100 0 0
Addiction
Mental Health 268239 268239 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Computer delivered motivational interviewing and cognitive behavioural therapy (SHADE therapy: Self-Help for Alcohol and other drug use and Depression). Individuals in this condition will complete 2 x 50 minute sessions of the SHADE program each week, over a period of 5 weeks.
Intervention code [1] 266657 0
Rehabilitation
Intervention code [2] 266779 0
Treatment: Other
Intervention code [3] 266780 0
Behaviour
Comparator / control treatment
A computer delivered touch typing skills program (Type Master Pro). Individuals in this condition will complete 2 x 50 minute sessions of the Type Master Pro each week, over a period of 5 weeks.
Control group
Active

Outcomes
Primary outcome [1] 266848 0
Opiate Treatment Index (OTI)
Timepoint [1] 266848 0
3 months
Primary outcome [2] 266849 0
Beck Depression Inventory (BDI-II)
Timepoint [2] 266849 0
5 weeks and 3 months
Secondary outcome [1] 276496 0
Dysfunctional Attitudes Questionnaire
Timepoint [1] 276496 0
5 weeks and 3 months
Secondary outcome [2] 276497 0
Drug Taking Confidence Questionnaire (DTCQ)
Timepoint [2] 276497 0
5 weeks and 3 months
Secondary outcome [3] 276498 0
Drug Risk Response Test (DRRT)
Timepoint [3] 276498 0
5 week and 3 months
Secondary outcome [4] 276499 0
Ways of Responding (WOR)
Timepoint [4] 276499 0
5 weeks and 3 months
Secondary outcome [5] 276500 0
PENN Alcohol Cravings Questionnaire
Timepoint [5] 276500 0
5 weeks and 3 months

Eligibility
Key inclusion criteria
All participants attending The Salvation Army William Booth Program will be asked to participate. All participants will have an alcohol or other substance abuse disorder. Previous surveys of The Salvation Army program indicates that approximately 50% of participants report a previous mental health diagnosis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant acquired brain injury

People who's primary language is other than english

People who are acutely suicidal

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)
Participants will be in the first 3-weeks of the William Booth Program. They will complete a structured interview with a research assistant. At the completion of the interview they will be randomly allocated to one of the conditions (1) Treatment (SHADE) or (2) Active Control (Type Master Pro). .
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants upon entry to the study will be given a unique numerical code. This unique code will have previously been randomly assigned a treatment allocation using a random numbers table. The treatment assignment will be written on a piece of paper, and inserted into a blank envelope with the unique participant code written on the front of the envelope. Upon completion of the
initial assessment, the participant will be asked to open the relevant envelope (the one with their unique code entered on the front) to reveal their treatment allocation. The randomisation procedure will stratify for both gender and whether the person is currently taking antidepressant
medication to ensure the proportion of males & females, and individuals with a history of depression is consistent across the two groups. Randomisation will be blocked so that the distribution of participants across treatment conditions will be maintained regardless of the final sample size.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/04/2011
Actual
4/03/2011
Date of last participant enrolment
Anticipated
Actual
3/12/2012
Date of last data collection
Anticipated
Actual
3/12/2012
Sample size
Target
200
Accrual to date
Final
189
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 23504 0
2000 - Sydney
Recruitment postcode(s) [2] 23505 0
4059 - Red Hill

Funding & Sponsors
Funding source category [1] 267147 0
Charities/Societies/Foundations
Name [1] 267147 0
Australian Rotary Health
Country [1] 267147 0
Australia
Primary sponsor type
University
Name
The University of Wollongong
Address
Wollongong Campus
Wollongong, NSW
2522
Country
Australia
Secondary sponsor category [1] 266219 0
University
Name [1] 266219 0
University of New South Wales
Address [1] 266219 0
UNSW KENSINGTON CAMPUS
SYDNEY, NSW
2052
Country [1] 266219 0
Australia
Secondary sponsor category [2] 266220 0
University
Name [2] 266220 0
University of Newcastle
Address [2] 266220 0
Callaghan Campus
Callaghan, NSW
2308
Country [2] 266220 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269138 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 269138 0
Ethics committee country [1] 269138 0
Australia
Date submitted for ethics approval [1] 269138 0
Approval date [1] 269138 0
24/03/2011
Ethics approval number [1] 269138 0
HE09/091

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

Contacts
Principal investigator
Name 32465 0
Dr Peter Kelly
Address 32465 0
Northfields Avenue,
School of Psychology,
University of Wollongong
NSW, Australia 2500
Country 32465 0
Australia
Phone 32465 0
+61 2 42 39 23 82
Fax 32465 0
Email 32465 0
[email protected]
Contact person for public queries
Name 15712 0
Peter Kelly
Address 15712 0
School of Psychology
Wollongong Campus
University of Wollongong
NSW, 2522
Country 15712 0
Australia
Phone 15712 0
+61 2 42 39 2382
Fax 15712 0
Email 15712 0
[email protected]
Contact person for scientific queries
Name 6640 0
Peter Kelly
Address 6640 0
School of Psychology
Wollongong Campus
University of Wollongong
NSW, 2522
Country 6640 0
Australia
Phone 6640 0
+61 2 42 39 2382
Fax 6640 0
Email 6640 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseStudy protocol: a randomized controlled trial of a computer-based depression and substance abuse intervention for people attending residential substance abuse treatment.2012https://dx.doi.org/10.1186/1471-2458-12-113
N.B. These documents automatically identified may not have been verified by the study sponsor.