Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000437460
Ethics application status
Approved
Date submitted
21/08/2007
Date registered
29/08/2007
Date last updated
30/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Computer-based psychological treatment for co-occurring depression and substance use problems
Scientific title
In patients with comorbid depression and problematic use of alcohol, cannabis and/or amphetamines, is computer-based cognitive behaviour therapy as efficacious as an equivalent therapist-delivered cognitive behaviour therapy program and/or superior to a brief intervention control group in reducing symptoms of depression and levels of substance use?
Universal Trial Number (UTN)
Trial acronym
The SHADE project (Self-Help for Alcohol/other drug use and DEpression)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 2283 0
Alcohol/other drug use 2284 0
Condition category
Condition code
Mental Health 2377 2377 0 0
Depression
Mental Health 2378 2378 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group 1: computer-delivered cognitive behaviour therapy (10 once weekly sessions of 60 mins duration, delivered via a computer program, with once weekly 10-15 min check-in sessions delivered by a therapist)
Intervention group 2: therapist-delivered cognitive behaviour therapy (10 once weekly sessions of 60 mins duration delivered by a therapist)
Intervention code [1] 1996 0
Behaviour
Intervention code [2] 1997 0
Treatment: Other
Intervention code [3] 2018 0
Lifestyle
Comparator / control treatment
Intervention group 3: brief (control) motivational therapy (a one-off 60-minute session delivered by a therapist). Please note that all participants in the trial, regardless of treatment allocation, received this session as their initial treatment session. Randomisation to further intervention groups occurred at the conclusion of this brief intervention session. Those allocated to the control condition, received no further treatment after this one-session brief intervention.
Control group
Active

Outcomes
Primary outcome [1] 3274 0
Reduction in depression scores as measured by the Beck Depression Inventory II
Timepoint [1] 3274 0
baseline, post-treatment (15 weeks post-initial), 6-month follow-up (6-months post-initial), 12-month follow-up (12-months post-initial)
Primary outcome [2] 3275 0
Reduction in alcohol use as measured by the Optiate Treatment Index
Timepoint [2] 3275 0
baseline, post-treatment (15 weeks post-initial), 6-month follow-up (6-months post-initial), 12-month follow-up (12-months post-initial)
Primary outcome [3] 3276 0
Reduction in cannabis use as measured by the Optiate Treatment Index
Timepoint [3] 3276 0
baseline, post-treatment (15 weeks post-initial), 6-month follow-up (6-months post-initial), 12-month follow-up (12-months post-initial)
Secondary outcome [1] 5458 0
Improvement in general functioning as measured by the Global Assessment of functioning
Timepoint [1] 5458 0
baseline, post-treatment (15 weeks post-initial), 6-month follow-up (6-months post-initial), 12-month follow-up (12-months post-initial)

Eligibility
Key inclusion criteria
a.Current depressive symptomatology, as indicated by a score of 17 or greater on the Beck Depression Inventory II;
b. Lifetime diagnosis of major depressive disorder, as confirmed by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disroders, 4th Edition (DSM-IV), Research Version;
c. Current problematic use of at least one of the following: alcohol (i.e. consumption above recommended drinking levels in Australia; equates to 4 standard drinks per day for men or 2 standard drinks per day for women with fewer than 2 alcohol free days per week); cannabis (at least weekly use); or amphetamines (at least weekly use);
d. 16 years or over
e. Absence of a brain injury, organic brain disease and/or significant cognitive impairment; and
f. Ability to understand English.
Minimum age
16 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Current psychotic disorder
b. Brain injury, organic disease and/or significant cognitive impairment
c. Inability to understand English

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)
Following provision of formal consent, all eligible participants completed an initial assessment. Each participant then commenced the treatment phase of the study, which started with a brief (one-session) intervention. Participants were randomly assigned to receive one of three treatment allocations at the conclusion of the brief intervention: no further treatment (treatment as usual/control condition), nine further sessions of cognitive behaviour therapy delivered by a psychologist, or nine further sessions of cognitive behaviour therapy delivered by a computer (with brief 10-15 minute weekly input from a psychologist). The research clinicians were blind to treatment allocation until the conclusion of the initial brief intervention session. Allocation involved contacting a centrally-located administrative assistant who was not involved in the assessment or treatment phases of the study, nor the research project in general. Treatment allocations were transferred from an externally generated randomisation list by the Administrative Assistant and concealed in individual opaque envelopes labelled with the relevant participant code. Prior to the brief intervention session for each participant, the research clinicians were issued with a new randomisation envelope by the Administrative Assistant, which displayed the participant number on the outside of the envelope, and with the treatment allocation sealed inside. The envelope was opened by the participant at the conclusion of the brief intervention session.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation list was generated by the Research Manager of the Centre at which the study was conducted, and was linked to a unique participant identification code (i.e. 1-120). The Research Manager was not involved with the assessment or treatment phases of the study. A permuted block randomisation approach was used so that the distribution of participants across treatment conditions could be maintained regardless of the final sample size.
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
Completed
Date of first participant enrolment
Anticipated
31/03/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 381 0
2300

Funding & Sponsors
Funding source category [1] 2535 0
Charities/Societies/Foundations
Name [1] 2535 0
Australian Brewer's Foundation
Country [1] 2535 0
Australia
Funding source category [2] 2536 0
Charities/Societies/Foundations
Name [2] 2536 0
Phillip Emlyn Thomas Scholarship/Award
Country [2] 2536 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan 2308
Country
Australia
Secondary sponsor category [1] 2294 0
Government body
Name [1] 2294 0
Hunter New England Mental Health
Address [1] 2294 0
Area Headquarters
Locked Bag 1
New Lambton 2305
Country [1] 2294 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4450 0
Hunter New England Health Human Research Ethics Committee
Ethics committee address [1] 4450 0
Ethics committee country [1] 4450 0
Australia
Date submitted for ethics approval [1] 4450 0
Approval date [1] 4450 0
18/07/2002
Ethics approval number [1] 4450 0
02/03/13/3.16
Ethics committee name [2] 4451 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 4451 0
Ethics committee country [2] 4451 0
Australia
Date submitted for ethics approval [2] 4451 0
Approval date [2] 4451 0
15/05/2002
Ethics approval number [2] 4451 0
H 307 0502

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

Contacts
Principal investigator
Name 27997 0
Address 27997 0
Country 27997 0
Phone 27997 0
Fax 27997 0
Email 27997 0
Contact person for public queries
Name 11154 0
Frances Kay-Lambkin
Address 11154 0
Centre for Brain and Mental Health Research
University of Newcastle
James Fletcher Hospital
PO Box 833
Newcastle NSW 2300
Country 11154 0
Australia
Phone 11154 0
+61 2 4924 6667
Fax 11154 0
+61 2 4924 6608
Email 11154 0
Frances.KayLambkin@newcastle.edu.au
Contact person for scientific queries
Name 2082 0
Frances Kay-Lambkin
Address 2082 0
Centre for Brain and Mental Health Research
University of Newcastle
James Fletcher Hospital
PO Box 833
Newcastle NSW 2300
Country 2082 0
Australia
Phone 2082 0
+61 2 4924 6667
Fax 2082 0
+61 2 4924 6608
Email 2082 0
Frances.KayLambkin@newcastle.edu.au

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
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Documents added automatically
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