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Trial registered on ANZCTR


Registration number
ACTRN12611000382976
Ethics application status
Approved
Date submitted
12/04/2011
Date registered
13/04/2011
Date last updated
13/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A dissemination trial of computerized psychological treatment for depression and alcohol/other drug use comorbidity in an Australian Clinical Service.
Scientific title
A dissemination trial of a computerized psychological treatment for depression and substance use comorbidity (SHADE) among current clients and clinicians associated with the Northern Sydney Central Coast Drug and Alcohol Clinical Service, New South Wales, Australia
Secondary ID [1] 259989 0
Nil
Universal Trial Number (UTN)
U1111-1120-7020
Trial acronym
SHADE Dissemination Trial - Central Coast DACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol use 265615 0
Cannabis use 265616 0
Depression 265617 0
Anxiety 265618 0
Condition category
Condition code
Mental Health 265765 265765 0 0
Addiction
Mental Health 265766 265766 0 0
Depression
Mental Health 265767 265767 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The SHADE treatment program incorporates cognitive behaviour therapy and motivational enhancement strategies to encourage reductions in depression and alcohol/other drug use. The program is available in two formats: (i) a 10-session program designed to be completed in a linear fashion, once weekly for 10 weeks, with content pre-programmed for each session; and (ii) a skill module program, where a series of shorter modules are presented based on themes related to depression and AOD use problems (e.g. coping with cravings, taking charge of my thoughts, staying well) arising from the 10-week program. Clients and/or clinicians may choose to focus on just one skill module during a session, without having to complete the other skills and strategies contained in the resource. Both versions of the SHADE program appear on the one DVD-Rom from which the program operates. Text is pitched at a reading age of 14 years, with a voiceover available to read out all text contained in the resource. Video case scenarios guide clients through a range of skills and strategies, and a range of handouts and worksheets are also available for clients/clinicians to print out and use during a session or as a homework activity.

This study is an intervention study, however the way in which the SHADE program is used is not prescribed or mandated by the research team. Clinicians have received training in the use of the 10-session linear SHADE program (10 weekly sessions of approximately 60mins duration) and the SHADE SKill Modules (8 smaller modules of approximately 30 minutes duration) and asked to use either the linear or skill module program as per their clinical judgement. This includes decisions based on whether to implement the full 10-session linear program or any of the skill modules, whether to complete the program during a session with a client at the Clinic, or to provide SHADE to the client to take home and complete as homework or in between sessions.
Intervention code [1] 264403 0
Treatment: Other
Intervention code [2] 264404 0
Behaviour
Comparator / control treatment
Usual treatment within the Central Coast Drug and Alcohol Clinical Service (DACS), New South Wales, Australia. The DACS forms part of a general health service, and provides a range of clinical interventions to residents within the catchment area with AOD use problems. Services include counselling, detoxification (hospital-based and outreach), needle and syringe programs, pharmacotherapy services, a diversion program for people with AOD use problems and legal issues (Magistrates Early Referral Into Treatment, MERIT), and a specialist service targeting clients with a primary drug of concern of marijuana. A central intake service acts as the point of initial contact for access to DACS, with subsequent referrals made to relevant services as appropriate. Client and Clinician participants will be recruited from the counselling services associated with the Central Coast DACS. There are three counselling teams within this service, AOD Counselling, Marijuana Clinic and MERIT.
Control group
Active

Outcomes
Primary outcome [1] 266519 0
Reduction in alcohol use as measured by the Opiate Treatment Index (OTI, Darke et al., 1992).
Timepoint [1] 266519 0
Baseline and 3-month post-baseline
Primary outcome [2] 266520 0
Reduction in cannabis use, as measured by the Opiate Treatment Index (OTI, 1992)
Timepoint [2] 266520 0
Baseline and 3-month post-baseline
Primary outcome [3] 266521 0
Reductions in Depression, Anxiety, Stress, as measured by the Depression, Anxiety, Stress Scale (DASS, Lovibond et al., 1987)
Timepoint [3] 266521 0
Baseline and 3-month post-baseline
Secondary outcome [1] 273952 0
Use of the SHADE computerised treatment resource, as reported by clinicians of the Drug and Alcohol Clinical Service
Timepoint [1] 273952 0
Weekly session checklists completed for each participants throughout the study period
Secondary outcome [2] 273953 0
Changes in Therapeutic Alliance, as measured by the Agnew Relationship Measure (ARM, 1998)
Timepoint [2] 273953 0
Baseline and 3-months post-baseline - clients

Clinicians will also complete the therapist-version of the scale during theirfirst session with a client, and the final session of the treatment occasion.
Secondary outcome [3] 273954 0
Changes in Treatment Motivation, as measured by the Treatment Motivation Questionnaire (TMQ,
Timepoint [3] 273954 0
Baseline and 3-month post-baseline
Secondary outcome [4] 273955 0
Changes in self compassion, as measured by the Self-Compassion Scale (Neff, 2003)
Timepoint [4] 273955 0
Baseline and 3-month post-baseline
Secondary outcome [5] 273956 0
Changes in functioning, as measured by the Global Assessment of Functioning (GAF, APA, 1994).
Timepoint [5] 273956 0
Baseline and 3-months post-baseline

Eligibility
Key inclusion criteria
Current engagement as a client of the Central Coast Drug and Alcohol Clinical Service, New South Wales, Australia
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients referred for detoxification

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All clients, new and ongoing, will be invited to partake in the study. Participants will be aged 18 years and over and residing on the Central Coast and surrounding areas of New South Wales. Participants will consist of individuals attending counselling with primary presenting issues related to substance abuse or dependence.

Following the provision of contact details to the research team via their clinician, current and ongoing clients of the Drug and Alcohol Clinical Service (DACS) are contacted to discuss consent to participate in the study. Once consent is established, clients complete a baseline and 12-week follow-up assessment delivered over the telephone by research assistants independent from the DACS. Clients are reimbursed $20 AUD for each completed assessment.

New referral to the DACS, via the centralized intake service, who have not been allocated to a clinician, will be contacted by AH, SW or MB (clinicians of the DACS) to discuss study participation and consent to release contact details to the research team. Once these details have been provided to the research team, wait-list clients consent to complete a baseline and 12-week telephone assessment in the same manner as current/ongoing clients. Wait-list clients are reimbursed $20 AUD for each completed assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264867 0
University
Name [1] 264867 0
University of Newcastle
Address [1] 264867 0
University Drive
Callaghan NSW 2308
Country [1] 264867 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 263969 0
University
Name [1] 263969 0
University of NSW
Address [1] 263969 0
National Drug and Alcohol Research Centre
University of New South Wales
Sydney NSW 2052
Country [1] 263969 0
Australia
Other collaborator category [1] 251940 0
Other Collaborative groups
Name [1] 251940 0
Central Coast Drug and Alcohol Clinical Service
Address [1] 251940 0
Northern Sydney Central Coast Area Health Service
c/- 38A Pacific Highway
Wyong NSW 2259
Country [1] 251940 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266827 0
Northern Sydney Central Coast Human Research Ethics Committee
Ethics committee address [1] 266827 0
Ethics committee country [1] 266827 0
Australia
Date submitted for ethics approval [1] 266827 0
Approval date [1] 266827 0
30/09/2008
Ethics approval number [1] 266827 0
08/HARBR/78/79
Ethics committee name [2] 266828 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 266828 0
University Drive
Callaghan NSW 2308
Ethics committee country [2] 266828 0
Australia
Date submitted for ethics approval [2] 266828 0
Approval date [2] 266828 0
23/09/2008
Ethics approval number [2] 266828 0
H-2008-0271

Summary
Brief summary
19 clinicians within an AOD service on the Central Coast of New South Wales, Australia, will be recruited to the trial. Consenting clinicians will participate in a baseline focus group discussion designed to explore their experiences and perceived barriers to adopting innovation in their clinical practice. Computer comfort and openness to innovation will also be assessed. Throughout the trial, current, new and wait-list clients will be referred to the research program via the clinical service, which will involve clients completing a baseline and 15-week follow-up clinical assessment with independent research assistants, comprising a range of mental health and AOD measures. Clinicians will also complete session checklists following each clinical session with a client, outlining the extent to which the SHADE computer program was used. Therapeutic alliance will be measured at intake and discharge from both the clinician and client perspectives.

This study will provide comprehensive data on the factors associated with the adoption of an innovative, computer-delivered evidence-based treatment program, SHADE, by clinicians working in an AOD service. The results will contribute to the development of a model of dissemination of SHADE, which could be applied to a range of technological innovations.
Trial website
Nil
Trial related presentations / publications
Nil to date
Public notes

Contacts
Principal investigator
Name 32479 0
Address 32479 0
Country 32479 0
Phone 32479 0
Fax 32479 0
Email 32479 0
Contact person for public queries
Name 15726 0
Frances Kay-Lambkin
Address 15726 0
National Drug and Alcohol Research Centre
Randwick Campus, University of NSW
22 – 32 King Street
Randwick NSW 2031
Country 15726 0
Australia
Phone 15726 0
+61240335690
Fax 15726 0
+61240335692
Email 15726 0
f.kaylambkin@unsw.edu.au
Contact person for scientific queries
Name 6654 0
Frances Kay-Lambkin
Address 6654 0
National Drug and Alcohol Research Centre
Randwick Campus, University of NSW
22 – 32 King Street
Randwick NSW 2031
Country 6654 0
Australia
Phone 6654 0
+61240335690
Fax 6654 0
+61240335692
Email 6654 0
f.kaylambkin@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
No Results