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Keep it Real: A web-based program for psychotic-like experiences and cannabis use

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001107213
Acronym
KIR RCT 2018
Enrollment
1992
Registered
2018-07-03
Start date
2018-07-09
Completion date
2018-09-28
Last updated
2019-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Young cannabis users (16-25 years) will be recruited from the general community and substance use services to complete an online survey exploring the relationship between cannabis use and psychosis. They will be asked to repeat the online survey at 6 and 12-month follow ups. Eligible participants (past month cannabis use + at least 3 Psychotic Experiences (PLEs) ‘sometimes’ or 1 PLE ‘nearly always’ in the past 3 months; who express interest in trialling a website for PLEs during the baseline survey will then be invited to participate in a randomised controlled trial (RCT) comparing the efficacy and usability of the Keep it Real website versus a minimal web-based Information Control Website (ICW). Four followup online surveys will be completed at 3, 6, 9 and 12 months post baseline.

Interventions

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 an

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.

Sponsors

University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
16 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

1. Aged 16-25 years 2. Used cannabis at least once in the past month 3. CAPE15 >18

Exclusion criteria

1. History of traumatic brain injury or organic brain disease 2. Current acute suicide risk 3. Insufficient English fluency.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 20, 2026