Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000995370
Ethics application status
Approved
Date submitted
6/07/2017
Date registered
11/07/2017
Date last updated
9/12/2020
Date data sharing statement initially provided
17/06/2019
Date results information initially provided
17/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating an instant assessment feedback tool among cannabis users referred to treatment.
Scientific title
Evaluating an instant assessment feedback tool on motivation to change among cannabis users referred to treatment.
Secondary ID [1] 291783 0
None.
Universal Trial Number (UTN)
U1111-1195-9854
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cannabis dependence
 303011 0
Condition category
Condition code
Mental Health 302470 302470 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Instant Assessment Feedback Tool

Why: A thorough clinical assessment with personalised feedback of results is an important component of treatment planning and delivery. For psychological treatments, much of this assessment involves administration of validated, standardized questionnaires. This is time consuming because of the manual scoring and interpretation of results that is required. This intervention aims to increase the efficiency of clinical practice and enhance patient's motivation to change their current cannabis use behaviour. This trial will evaluate a newly developed instant assessment feedback tool.

What: Patients who present for a cannabis assessment session at a public hospital will complete the battery of routinely administered measures and questionnaires using a computerized tablet. Once the measures are completed, the instant assessment feedback tool automatically scores the patient's results and presents them on the clinician's computer screen in tables and graphs. There is a screen which provides a summary of scores for the current patient, and highlights the patient's score on a particular measure if they have met a clinical cut-off (e.g. met the criteria for cannabis dependence). The patient's results for severity of cannabis dependence, negative effects of cannabis use and cannabis refusal self-efficacy are presented in graphs that compare their scores with normative data (e.g. non-dependent cannabis users and cannabis users in outpatient treatment) - which are known predictors of treatment outcomes. The clinician can then show the patient how their scores compare to other groups of cannabis users. At the end of the session, the patient is provided with a print out of their results.

Materials: The battery of questionnaires that are routinely administered to patients during the cannabis assessment session measure the following outcomes: cannabis use (Cannabis Assessment), severity of cannabis dependence (Severity of Dependence Scale - Cannabis), psychological functioning and well-being (The General Health Questionnaire - 28), cannabis cravings (The Craving Experience Questionnaire - Cannabis), readiness to change cannabis use (The Readiness to Change Questionnaire), the presence of alcohol and substance use disorders (The Alcohol Use Disorders Identification Test ), the presence of depression and anxiety (The Depression, Anxiety and Stress Scale) , cannabis outcome expectancies (The Cannabis Expectancy Questionnaire), cannabis refusal self-efficacy (The Cannabis Refusal Self-Effiacy Questionnaire) and impulsivity personality traits (The Sensitivity to Reward Scale & The Dysfunctional Impulsivity Scale).

Clinicians will be provided with an information sheet that describes how to interpret patient scores and provides suggested scripts for explaining the patient's results.

Who: Clinical staff who administer the cannabis assessment session. These staff are registered psychologists, social workers and nurses.

How: The intervention will be delivered face - to - face and individually.

Where: The intervention will be delivered at an outpatient Alcohol and Drug Unit at a public hospital.

Necessary infrastructure: To be administered, this intervention requires computers with internet access and computerized tablets.

Number of times: The intervention will be delivered once, in a two hour session.

Intervention adherence and fidelity: Will not be assessed.
Intervention code [1] 297894 0
Treatment: Devices
Intervention code [2] 297895 0
Lifestyle
Comparator / control treatment
Brief name: Treatment as usual.

What: This group will complete the same battery of routine measures and questionnaires as those in the intervention condition, but using a paper-based version. The clinician will manually score the measures of their choosing and provide feedback to patient on their results in accordance with the clinician's usual approach. This condition conducts the asessment in accordance with the current routine practice.

All other elements of the treatment as usual condition are equal to instant assessment feedback tool condition.
Control group
Active

Outcomes
Primary outcome [1] 301890 0
Between-condition and within-condition changes in motivation to change current cannabis use behaviour.

Instrument: A set of 5-items called 'Change Rulers' were adapted from Motivational Interviewing resources to assess motivation to change current cananbis use behaviour.
Timepoint [1] 301890 0
The 'Change Rulers' measure will be administered twice - once at the beginning and once at the end of the cannabis assessment session.
Secondary outcome [1] 334197 0
Between-condition patient ratings of satisfaction with the cannabis assessment session.

Instrument: A set of 10-items were developed to measure the patients' degree of satisfaction with the cannabis assessment session.
Timepoint [1] 334197 0
The 'Patient Satisfaction' measured at the end of the cannabis assessment session.

Eligibility
Key inclusion criteria
Patients who present for a cannabis assessment session at the location of this study are eligble for inclusion.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with severe cognitive impairment or a comorbid mental health disorder that is assessed by the clinician as potentially impairing their decision making will be automatically excluded from the study and offered treatment as usual.

Patients under the age of 18 may be excluded from the study if the clinician believes they are emotionally or cognitively incompetent to make an informed decision to paticipant. These patients will be offered treatment as usual.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 80 was determined by using conservative estimates of historical patient numbers and power calculations. This sample size has sufficient power at .80 to find a medium intervention effect size. Power calculations were based on effect sizes reported in past studies evaluating the Marijuana Check-Up (partial eta squared = 0.04 - 0.06), in which they compare a personalised feedback condition to an educational control condition.

Multilevel modeling will be used to evaluate the effectiveness of the intervention.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2017
Actual
6/11/2017
Date of last participant enrolment
Anticipated
30/09/2018
Actual
31/08/2018
Date of last data collection
Anticipated
30/09/2018
Actual
31/08/2018
Sample size
Target
80
Accrual to date
Final
87
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7893 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 15849 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 296286 0
Hospital
Name [1] 296286 0
The Princess Alexandra Hospital
Country [1] 296286 0
Australia
Primary sponsor type
Individual
Name
Matthew Gullo
Address
The Alcohol and Drug Assessment Unit
The Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, Brisbane, QLD
4102
Country
Australia
Secondary sponsor category [1] 295208 0
Individual
Name [1] 295208 0
Jason Connor
Address [1] 295208 0
The Alcohol and Drug Assessment Unit
The Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, Brisbane, QLD
4102
Country [1] 295208 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297519 0
Metro South Health Service District Human Research Ethics Committee (EC00167)
Ethics committee address [1] 297519 0
PAH Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 297519 0
Australia
Date submitted for ethics approval [1] 297519 0
18/04/2017
Approval date [1] 297519 0
20/06/2017
Ethics approval number [1] 297519 0
HREC/17/QPAH/278

Summary
Brief summary
The aim of this study is to evaluate a new, auto-scoring, instant assessment feedback tool which can be utilized by clinicians during cannabis use assessment sessions.

To achieve this aim, a randomized controlled trial will be conducted. Patients who present for an assessment of their cannabis use and consent to being involved in the trial will be randomized to the "instant assessment feedback tool" or "treatment as usual" condition.

Patients in each condition will complete the same battery of validated, standardized questionnaires that are routinely administered during the assessment session.

Patients in the "treatment as usual" condition will complete paper-based versions of the measures and will receive feedback on the measures in accordance with the clinician's usual approach.

Patients in the "instant assessment feedback tool" condition will complete the same questionnaires using a tablet computer. The instant assessment feedback tool automatically scores the patient’s responses on the measures and presents their results on the clinician’s computer screen in tables and graphs, including comparisons with averages/norms from non-dependent cannabis users and cannabis users in treatment. The clinician will then discuss the patient’s results with them and show them visually how their scores compare to other groups of problematic and non-problematic cannabis users. These patients will be given a print-out summary of their results to take home with them.

A brief pre- and post- session measure of motivation to change and a brief post-session measures of patient satisfaction will be also administered.

It is hypothesized that patients who receive the instant assessment feedback tool will have significantly greater increases in their motivation to change their current cannabis use behaviour from pre- to post- assessment session compared to those in the treatment as usual condition. It is also predicted that patients in the instant assessment feedback tool condition will have significantly higher ratings of satisfaction with the assessment session compared to the assessment as usual condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74302 0
Dr Matthew Gullo
Address 74302 0
The Alcohol and Drug Assessment Unit
The Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, Brisbane, QLD
4102
Country 74302 0
Australia
Phone 74302 0
+61 7 3240 5191
Fax 74302 0
+61 7 3240 5171
Email 74302 0
[email protected]
Contact person for public queries
Name 74303 0
Dr Matthew Gullo
Address 74303 0
The Alcohol and Drug Assessment Unit
The Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, Brisbane, QLD
4102
Country 74303 0
Australia
Phone 74303 0
+61 7 3240 5191
Fax 74303 0
+ 61 7 3240 5171
Email 74303 0
[email protected]
Contact person for scientific queries
Name 74304 0
Dr Matthew Gullo
Address 74304 0
The Alcohol and Drug Assessment Unit
The Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, Brisbane, QLD
4102
Country 74304 0
Australia
Phone 74304 0
+61 7 3240 5191
Fax 74304 0
+ 61 7 3240 5171
Email 74304 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in published articles, after deidentification (text, tables, figures and appendices).
When will data be available (start and end dates)?
Beginning 6 months and ending 5 years following article publication.
Available to whom?
Researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose.
Available for what types of analyses?
To achieve aims in the approved proposal.
How or where can data be obtained?
Proposals should be directed to [email protected]. To gain access, data requestors will need to sign a data access agreement. After 5 years the data will be available in our University’s data warehouse but without investigator support other than deposited metadata at https://rdm.uq.edu.au/


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2368Study protocol    https://drive.google.com/file/d/0BxusmPrEbnF4UUdxS... [More Details]



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAdditive effectiveness and feasibility of a theory-driven instant assessment and feedback system in brief cannabis intervention: A randomised controlled trial.2021https://dx.doi.org/10.1016/j.addbeh.2020.106690
N.B. These documents automatically identified may not have been verified by the study sponsor.