ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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 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]

None.

Universal Trial Number (UTN)

U1111-1195-9854

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cannabis dependence

Condition category

Condition code

Mental Health

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]

Treatment: Devices

Intervention code [2]

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]

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]

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]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Princess Alexandra Hospital

Address [1]

199 Ipswich Road
Woolloongabba QLD 4102

Country [1]

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]

Individual

Name [1]

Jason Connor

Address [1]

The Alcohol and Drug Assessment Unit
The Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, Brisbane, QLD
4102

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Health Service District Human Research Ethics Committee (EC00167)

Ethics committee address [1]

PAH Centres for Health Research 
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/04/2017

Approval date [1]

20/06/2017

Ethics approval number [1]

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

Dr Matthew Gullo

Address

The Alcohol and Drug Assessment Unit
The Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, Brisbane, QLD
4102

Country

Australia

Phone

+61 7 3240 5191

Fax

+61 7 3240 5171

m.gullo@uq.edu.au

Contact person for public queries

Name

Matthew Gullo

Address

The Alcohol and Drug Assessment Unit
The Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, Brisbane, QLD
4102

Country

Australia

Phone

+61 7 3240 5191

Fax

+ 61 7 3240 5171

m.gullo@uq.edu.au

Contact person for scientific queries

Name

Matthew Gullo

Address

The Alcohol and Drug Assessment Unit
The Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, Brisbane, QLD
4102

Country

Australia

Phone

+61 7 3240 5191

Fax

+ 61 7 3240 5171

m.gullo@uq.edu.au

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 m.gullo@uq.edu.au. 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.	Type	Citation	Link	Email	Other Details	Attachment
2368	Study protocol				https://drive.google.com/file/d/0BxusmPrEbnF4UUdxS... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Additive effectiveness and feasibility of a theory-driven instant assessment and feedback system in brief cannabis intervention: A randomised controlled trial.	2021	https://dx.doi.org/10.1016/j.addbeh.2020.106690

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically