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Trial registered on ANZCTR


Registration number
ACTRN12618001107213
Ethics application status
Approved
Date submitted
29/06/2018
Date registered
3/07/2018
Date last updated
4/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Keep it Real: A web-based program for psychotic-like experiences and cannabis use
Scientific title
Keep it Real: A web-based program for psychotic-like experiences and cannabis use
A Randomised Controlled Trial, Testing the Efficacy of the “Keep it Real” Website
Secondary ID [1] 294450 0
Nil
Universal Trial Number (UTN)
Trial acronym
KIR RCT 2018
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cannabis use with psychotic-like experiences amongst young people 307201 0
Cannabis use 308619 0
Psychosis 308620 0
Condition category
Condition code
Mental Health 306311 306311 0 0
Addiction
Mental Health 306312 306312 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study examines the efficacy and cost effectiveness of the Keep it Real website compared to an information-only control website (ICW) in cannabis users with psychotic-like experiences (PLEs).

Keep it Real is a web program which consists of 7 modules that can be completed in 2-3 x 30 minute sessions. PLEs are targeted first, given young people are more likely to be concerned about PLEs, than their cannabis use. The first 3 modules aim to increase the users’ ability to identify, understand and reduce distress associated with PLEs. Module 1 defines PLEs and provides detailed personal feedback on self-reported PLEs based on age and gender-specific norms. Module 2 provides information on risk factors for PLEs (including cannabis, trauma, stress, anxiety/depression), psychotic symptoms and disorders using fact sheets and videos. Module 3 provides information and normative data on different subtypes of PLEs and suggests a number of simple CBT techniques for their management.
Modules 4 and 5 use motivational interviewing techniques to target cannabis, alcohol, methamphetamine and heroin use. Interactive quizzes aim to increase knowledge for all substances. Substance use and related problems are assessed and personal feedback is provided relative to age and gender-specific norms. Normative feedback is also provided to increase awareness of the relationship between substance use and PLEs. Participants are then encouraged to set harm minimization or change goals and develop a plan for achieving them.
Module 6 targets users’ coping skills by providing training in cognitive behavioural techniques including stress management, problem solving, behavioural activation, and attention control retraining (mindfulness).
Module 7 encourages appropriate help seeking for PLEs and/or cannabis use and addresses any barriers to doing so.
Written material is at Year 7 reading level or less, minimising rare words and words > 3 syllables, keeping sentence construction simple and paragraphs short. Entered data in the program is retained centrally for subsequent review and printing by participants. All website modules are unlocked and can be accessed by the user at any time. All participants have continuous access to a Get Help section of the website, which provides the contact details of mental health and AOD services (including crisis care).
Links to the Keep it Real will be sent via SMS and email. Participants will be free to explore and utilise the website as much as they like, but SMS reminders will be sent to both groups 7, 14, and 21 days after access has been granted to remind them to access it.
Outcomes from the intervention will be compared with outcomes of participants who have used an ICW. This program delivers the information sheets from the Keep it Real program including ; (i) What is psychosis?; (ii) Am I at risk of developing psychosis?; (iii) What is Schizophrenia?; (iv) What is Bipolar Disorder?; (v) Alcohol facts; (vi) Methamphetamine facts; (vii) Cannabis facts; (viii) Heroin facts. Limited, information-only pages from four of the program’s modules have also been included in the ICW to increase the face validity of the program. These include: “What is a weird experience?”; “How does cannabis affect my mental health?”; “How does other substance use affect me?” and “Should I seek help?”. It does not provide personal feedback from assessments or normative feedback on cannabis, other substances, or PLEs at baseline or follow up. No information is given on how to manage PLEs; nor do the resources focus on building motivation to change cannabis use.

Participants will have indefinite access to the Keep it Real program once they create an account. ICW participants will be granted full access to the program after conclusion of the RCT.
Intervention code [1] 300740 0
Treatment: Other
Comparator / control treatment
Outcomes from the intervention will be compared with outcomes of participants who have used an information control website (ICW): This program delivers the information sheets from the Keep it Real program in a 6-module web-based format including (i) What are PLEs; (ii) What is psychosis?; (iii) Am I at risk of developing psychosis?; (iii) What is Schizophrenia?; (iv) What is Bipolar Disorder?; (v) Alcohol facts; (vi) Methamphetamine facts; (vii) Cannabis facts; (viii) Heroin facts (iv) Cannabis/alcohol/ amphetamines and mental health; (v) Facts about cannabis/alcohol/amphetamines/heroin; (vi). Limited, information-only pages from four of the program’s modules have also been included in the ICW. Those include: “What is a weird experience?”; How does cannabis affect my mental health?; “How does other substance use affect me?” and “SHOULD I SEEK HELP?” Do I need more help? It does not provide personal feedback from assessments or normative feedback on cannabis, other substances, or PLEs at baseline or follow up. No information is given on how to manage PLEs; nor do the resources focus on building motivation to change cannabis use or increasing users’ understanding of the relationship between their cannabis use and PLEs.
Review of the six information modules of the ICW should take approximately 30-60 minutes. Website access will be monitored via backend data capturing system, reporting on date, time and participant ID for all who have accessed the website. Those who have not logged in to review the website will receive reminder SMSs after 7, 14 and 21 days to encourage adherence.
Control group
Active

Outcomes
Primary outcome [1] 305319 0
Frequency of psychotic experiences and related distress, using the Community Assessment of Psychic Experiences (CAPE15)
Timepoint [1] 305319 0
Baseline, 3 months, 6 months, 9 months, 12 months
Primary outcome [2] 305320 0
Composite primary outcome of frequency/quantity of cannabis use in the past month measured using the Opioid Treatment Index (OTI)
Timepoint [2] 305320 0
Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcome [1] 344832 0
Health related quality of life, measured using the 5 level version of EuroQoL (EQ-5D-5L)
Timepoint [1] 344832 0
Baseline, 12 months
Secondary outcome [2] 344833 0
Smoking, alcohol and other drug use substance involvement scores on the Alcohol, Smoking and Substances Involvement Screening Test (ASSIST), reported through a composite score.
Timepoint [2] 344833 0
Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcome [3] 344834 0
General functioning, measures using the Multidimentional Adolescent Functioning Scale (MAFS)
Timepoint [3] 344834 0
Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcome [4] 344835 0
Anxiety severity, measured using the Generalized Anxiety Disorder scale (GAD-7)
Timepoint [4] 344835 0
Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcome [5] 348837 0
Depression symptom severity, measured using the Patient Health Questionnaire (PHQ-9)
Timepoint [5] 348837 0
Baseline, 3 months, 6 months, 9 months, 12 months

Eligibility
Key inclusion criteria
1. Aged 16-25 years
2. Used cannabis at least once in the past month
3. CAPE15 >18
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of traumatic brain injury or organic brain disease
2. Current acute suicide risk
3. Insufficient English fluency.

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)
The chief investigators, follow-up assessors and trial statistician will be blind to treatment group allocation, and any violations of blindness will be recorded.
Allocation concealment will be achieved as central randomisation will be done by a automated computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This project will utilise a secure, automated web-based project and data management system for RCTs. This system contains a computerised random number sequence generator incorporating random permuted blocks to allocate participants to (i) Keep it Real or (ii) the information control. Stratification will be by cannabis usage (daily or less), gender and age (16-20 years, 21-25 years). The randomisation sequence is concealed within the secure website and the allocation is automatically released when full eligibility criteria is met.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:

In our Keep it Real pilot study we recruited 1,089 past month cannabis users over 6 months (using the same recruitment strategies as the current RCT) to identify 860 cannabis users meeting our PLE inclusion criterion (CAPE15 >18). Of these, 295 (34%) expressed interest in participating in the Keep it Real pilot trial (66 (7%) no interest; 503 (58%) no response) and 213 (72%; 25% of total) were randomized. We will therefore need to recruit 1,992 cannabis users to randomize 498 participants.

The Keep it Real pilot study found a moderate effect size for reductions in the frequency of cannabis use (d=.46). Due to the uncontrolled nature of this pilot, we will take a conservative approach and anticipate small to moderate effects. To measure a moderate effect size of f=.20, alpha (a) set at 0.025 and power set at 0.95, we would require 191 participants per group (a total of 382). If baseline covariates accounting for about 40% of the variability in the outcome model were included in the calculations, then we would have 0.99 power to detect a small-moderate treatment effect. We predict a 20-30% attrition rate at 12 months based on our pilot data and previous work and will therefore need to randomize a total of 498 participants.

Analysis:

Preliminary one-way analyses of variance and Chi-square analyses will be undertaken to check for baseline group differences on demographic, primary and secondary outcomes and diagnostic status. To determine whether there are group differences on the primary and secondary outcome measures at 3, 6, 9 and 12 months a series of mixed effects model repeated measures analyses of variance (MMRM) will be employed. The within groups factor will be time (baseline, 3, 6, 9, 12 months) and group will be the between subjects factor. This technique can also control for potential confounds (e.g. frequency of other drug use and related problems) and identify moderators (e.g., age, gender, Childhood Trauma Questionnaire, Cannabis Experiences Questionnaire-Intoxication) of treatment outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/07/2018
Actual
Date of last participant enrolment
Anticipated
28/09/2018
Actual
Date of last data collection
Anticipated
31/10/2019
Actual
Sample size
Target
1992
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 299077 0
Government body
Name [1] 299077 0
Australian Government Department of Health
Country [1] 299077 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Psychology,
McElwain Building
The University of Queensland
St Lucia, QLD, 4072
Australia
Country
Australia
Secondary sponsor category [1] 298318 0
None
Name [1] 298318 0
Address [1] 298318 0
Country [1] 298318 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300012 0
University of Queensland Human Research Ethics Committee (A, B, and LNR).
Ethics committee address [1] 300012 0
Ethics committee country [1] 300012 0
Australia
Date submitted for ethics approval [1] 300012 0
30/01/2018
Approval date [1] 300012 0
12/03/2018
Ethics approval number [1] 300012 0
2018000181

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

Contacts
Principal investigator
Name 82258 0
Prof Leanne Hides
Address 82258 0
Level 2, UQ - School of Psychology
Sir Fred Schonell Drive
St Lucia QLD 4072
Australia
Country 82258 0
Australia
Phone 82258 0
+61 7 3365 6398
Fax 82258 0
Email 82258 0
[email protected]
Contact person for public queries
Name 82259 0
Leanne Hides
Address 82259 0
Level 2, UQ - School of Psychology
Sir Fred Schonell Drive
St Lucia QLD 4072
Australia
Country 82259 0
Australia
Phone 82259 0
+61 7 3365 6398
Fax 82259 0
Email 82259 0
[email protected]
Contact person for scientific queries
Name 82260 0
Leanne Hides
Address 82260 0
Level 2, UQ - School of Psychology
Sir Fred Schonell Drive
St Lucia QLD 4072
Australia
Country 82260 0
Australia
Phone 82260 0
+61 7 3365 6398
Fax 82260 0
Email 82260 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

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No documents have been uploaded by study researchers.

Documents added automatically
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