Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000456752
Ethics application status
Approved
Date submitted
19/04/2013
Date registered
19/04/2013
Date last updated
19/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A computerised psychological treatment for problematic cannabis use and depression in an early psychosis treatment service
Scientific title
The impact of a computerised treatment for cannabis use and depression on mood and substance use outcomes in young people attending early psychosis treatment clinics in NSW
Secondary ID [1] 282367 0
Nil
Universal Trial Number (UTN)
U1111-1138-1700
Trial acronym
The SHADE in early psychosis project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cannabis use 288939 0
Depression 288940 0
Cardiovascular Risk 288941 0
Condition category
Condition code
Mental Health 289279 289279 0 0
Depression
Mental Health 289280 289280 0 0
Addiction
Public Health 289281 289281 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The computerised psychological treatment program, SHADE, comprises 10 sessions of combination cognitive behaviour therapy and motivational interviewing focussed on reducing depression and reducing/ceasing alcohol/other drug use problems (including cannabis). It is delivered either in DVD or Internet-delivered format. All participants will complete the SHADE treatment over the Internet, excepting those who do not have reliable Internet access but have access to a computer in their homes. In these cases, participants will be offered the SHADE treatment program delivered via DVD. Participants are asked to complete each of the 10 session one week apart, with each session taking around 45 minutes to complete. Each computerised session is supported by a therapist (by telephone) who provides a compliance check of sessions completed, encouragement to continue engagement with the program, troubleshooting barriers to completing homework tasks, and a risk assessment (approximately 15 minutes duration). Telephone-based therapist support sessions occur once weekly over the 10-week intervention period.
Intervention code [1] 286995 0
Treatment: Other
Intervention code [2] 286996 0
Lifestyle
Intervention code [3] 286997 0
Behaviour
Comparator / control treatment
Wait-list control group (15 weeks post-baseline) who continue to attend regular scheduled appointments with their early psychosis clinic (no intervention for cannabis use or depression specifically provided).
Control group
Active

Outcomes
Primary outcome [1] 289381 0
Depressive Symptoms (as measured by the Depression, Anxiety Stress Scale - 21 item)
Timepoint [1] 289381 0
Baseline, 15 weeks post-baseline and 30-weeks post-baseline
Primary outcome [2] 289382 0
Cannabis use (as measured by the Opiate Treatment Index - Cannabis scale)
Timepoint [2] 289382 0
Baseline, 15-weeks post-baseline and 6-months post-baseline
Secondary outcome [1] 302384 0
Cardiovascular risk behaviours as measured by items that record Fruit and Vegetable intake (Food Frequency Questionnaire), Tobacco Use (Opiate Treatment Index - Tobacco), Physical Activity (International Physical Activity Questionnaire) and Sedentary Activity (Marshal et al., 2006)
Timepoint [1] 302384 0
Baseline, 15-weeks post-baseline and 6-month post-baseline
Secondary outcome [2] 302385 0
Computer Anxiety (Computer Anxiety Rating Scale)
Timepoint [2] 302385 0
Baseline, 15-weeks post-baseline and 6-months post-baseline

Eligibility
Key inclusion criteria
Participants will be currently engaged with the Bondi Junction Community Mental Health Service or the Campbelltown Community Mental Health Service for management of psychotic symptoms, be 18-30 years, and have used cannabis in the month prior to baseline.
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who cannot understand English sufficiently to complete the SHADE computerised program.

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)
Research Team members liaise with clinicians working in early psychosis clinics in the target area to identify potential participants for the study. Potential participants are provided with a "consent to release contact details" form by their treating clinician for consideration. Participants signing this form agree to have their contact details passed onto Research Team members, and are provided with the Participant Information Sheet and Consent Form by their treating clinician at the time of signing. One week following provision of these study documents, the Research Team will contact the potential participant via their preferred contact method to discuss the content of the Information Statement, answer any questions, to determine study eligibility and to discuss consent. Written consent will be obtained from each participant. Consenting, eligible participants will be enrolled in the study, and complete the baseline assessment with the Research Team via the telephone. At the conclusion of the baseline assessment, participants will receive their random allocation to SHADE or wait-list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated via a computerised table of random numbers, with the randomisation outcome (treatment/wait-list) being concealed in a sealed envelope by Dr Frances Kay-Lambkin. The outside of the envelopes will be labelled with study enrolment numbers, and participants will receive the relevant envelope (matching their study enrolment number) at the conclusion of the initial assessment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data coding and analysis will be carried out by the research team using available software packages (eg. SPSS). Variables hypothesised to change over time according to treatment allocation will be examined using repeated measures analysis of covariance (e.g. cannabis use). Chi-square analyses or logistic regression will be performed on categorical outcome variables (abstinence vs. not). Outcome measures will be analysed in two ways (1) intention to treat (with study dropouts regarded as continuing users and/or with unchanged scores relative to baseline); (2) performed with the sub-sample of participants who actually attended treatment and completed all follow-up phases. The sample size was determined based on feasibility of recruitment within the funding-body specified timeframe, with a file audit conducted within the Bondi Clinic in 2010 indicating that approximately 15-20 participants engaged with the service would meet eligibility criteria.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2013
Actual
Date of last participant enrolment
Anticipated
31/07/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 6769 0
2022 - Bondi Junction
Recruitment postcode(s) [2] 6770 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 287138 0
Government body
Name [1] 287138 0
New South Wales Drug and Alcohol Research Grants Program
Country [1] 287138 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
22-32 King Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 285905 0
Hospital
Name [1] 285905 0
Early Psychosis Program
Bondi Centre
Eastern Suburbs Mental Health Service
Address [1] 285905 0
26 Llandaff St.
Bondi Junction, NSW 2022
Country [1] 285905 0
Australia
Secondary sponsor category [2] 285906 0
Hospital
Name [2] 285906 0
Campbelltown Mental Health Service
Liverpool Hospital
Address [2] 285906 0
Mental Health Centre
Level 1, Liverpool Hospital
Locked Bag 7103
Liverpool NSW 1871
Country [2] 285906 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289137 0
South Eastern Sydney Human Research Ethics Committee
Ethics committee address [1] 289137 0
Ethics committee country [1] 289137 0
Australia
Date submitted for ethics approval [1] 289137 0
Approval date [1] 289137 0
10/04/2013
Ethics approval number [1] 289137 0
09/191

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

Contacts
Principal investigator
Name 39430 0
Dr Frances Kay-Lambkin
Address 39430 0
National Drug and Alcohol Research Centre
University of New South Wales
22-32 King Street
Randwick, NSW 2031
Country 39430 0
Australia
Phone 39430 0
+61293850333
Fax 39430 0
Email 39430 0
[email protected]
Contact person for public queries
Name 39431 0
Frances Kay-Lambkin
Address 39431 0
National Drug and Alcohol Research Centre
University of New South Wales
22-32 King Street
Randwick, NSW 2031
Country 39431 0
Australia
Phone 39431 0
+61293850333
Fax 39431 0
Email 39431 0
[email protected]
Contact person for scientific queries
Name 39432 0
Frances Kay-Lambkin
Address 39432 0
National Drug and Alcohol Research Centre
University of New South Wales
22-32 King Street
Randwick, NSW 2031
Country 39432 0
Australia
Phone 39432 0
+61293850333
Fax 39432 0
Email 39432 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
No additional documents have been identified.