To test the effectiveness of an online self-help training with adherence focused guidance on reducing cannabis use and increasing treatment service utilization in a sample of frequent cannabis users in a RCT. Primary objectiveTo test if an internet-…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
overmatig cannabisgebruik
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Frequency of cannabis use: the number of smoking days in the past 7 days
assessed 6 months post-randomisation using the Timeline Followback method.
Secondary outcome
2. Quantity of cannabis used (grams) in the past 7 days assessed 6 months post-
randomisation using the Timeline Followback method.
3. Cannabis use related problems as measured using the Cannabis Use Disorder
Identification Test (CUDIT).
4. Severity of dependence (number of self-reported DSM-5 criteria met).
5. Number of serious attempts to quit or reduce cannabis (self-report). A
serious quit attempt is defined as one lasting at least 24 hours.
6. Help seeking attitude as measured using the Mental Help Seeking Attitudes
Scale (MHSAS). An additional questionnaire used in previous research on help
seeking attitudes among frequent cannabis users is also include.
7. Number of participants that entered specialised drug treatment 6-months post
randomization (self-report).
8. Quality of life as measured with SF-6D.
9. Treatment satisfaction as measured with the Dutch version of the ZUF-8.
10. Demographics: age, sex, level of education.
11. Substance use (tobacco, alcohol, cocaine, amphetamine, inhalants,
sedatives, hallucinogens, opioids and other drugs).
12. MCSDS: Marlowe Crowne Social Desirability Scale will be included to
evaluate the reliability of the self-reported questionnaire data.
13. TiC-P: Direct non-medical cost data and productivity will be measured.
14. Number of self-reported cannabis withdrawal symptoms.
15. Marijuana Craving Questionnaire Short Form (MCQ-SF ) will be included to
assess craving for cannabis.
16. The Brief Symptom Inventory 18 (BSI-18) will be included to assess symptoms
of anxiety and depression.
17. Self-efficacy to become or stay a non-smoker and resist cannabis will be
measured by 6 items used in previous research.
18. The Cannabis self-concept scale will be included to assess identification
with cannabis as part of the participant*s personality or identity.
19. Utilization variables will be collected during use of the intervention:
number of logins, number of page views, time spend logged in, use of major
content elements (i.e. exercises).
20. Knowledge questionnaire to assess obtained knowledge about CBT principles.
21. Knowledge questionnaire to assess obtained knowledge about treatment
options/referral to treatment.
22. The effect of the coronavirus and the coronavirus measures on cannabis use
and attempts to reduce/quit cannabis use will be measured by 7 items.
Background summary
It is estimated that almost 1% of European adults uses cannabis daily or almost
daily. Regular cannabis use is associated with various adverse (mental) health
effects. Regular cannabis users are at risk for dependence. There are effective
treatments available for cannabis users. However, the majority of cannabis
users does not seek help. Internet-delivered interventions have several
advantages over traditional face-to-face treatments. Online interventions are
characterized by a high degree of anonymity, this minimizes the fear of being
stigmatized. Besides, they are easily accessible. Several online interventions
for cannabis users have been developed. In a recently published meta-analysis
on computerized interventions to reduce cannabis use, results showed a small
but significant effect in favour of computerized interventions compared to
control conditions. Thus, online interventions for cannabis use are effective
and have several advantages over face-to-face treatments. Therefore, they may
have the potential to improve treatment utilization among regular cannabis
users. It remains unclear whether online interventions are able to motivate
cannabis users to utilize specialized treatment services. Increasing drug
treatment utilization also does not appear to be an explicit goal of the
existing cannabis interventions. Given the low numbers of cannabis users
entering treatment, it seems important to focus on increasing motivation to
enter treatment. Interventions that aim to increase drug treatment utilization
are often based on the principles of the Screening Brief Intervention and
Referral to Treatment (SBIRT) approach. This research project aims to evaluate
the effectiveness of an online self-help training with adherence focused
guidance for cannabis users to motivate and support them to stop or reduce
their cannabis use and to refer them to treatment. The online training, a
progressive web app, is based on the principles of the Screening Brief
Intervention and Referral to Treatment (SBIRT) approach.
Study objective
To test the effectiveness of an online self-help training with adherence
focused guidance on reducing cannabis use and increasing treatment service
utilization in a sample of frequent cannabis users in a RCT.
Primary objective
To test if an internet-based self-help training (screening, personalized
feedback, brief intervention and referral to treatment) for reducing cannabis
use shows favorable effectiveness (effect size d =.40 ) compared to the control
condition (screening, feedback, online information brochure) on cannabis use 6
months post-randomisation.
Secondary objective
To test if an internet-based self-help training for reducing cannabis use shows
favorable effectiveness compared to the control group, on attitudes toward
seeking help for cannabis use related problems 6 months after randomisation.
Study design
A double blind randomized controlled trial will be carried out with a duration
of 6 months in an online setting. The trial will be 2 armed (internet-based
self-help training x online information brochure). Participants will be
allocated in a 1:1 ratio to the two trial arms. Participants will be assessed
on cannabis use related outcomes measures at T0 (baseline, before randomisation
), T1 (6 weeks post-randomisation), T2 (3 months post-randomisation) and T3 (6
months post-randomisation). 267 participants will be included.
Intervention
The online training, a progressive web app, is based on the principles of the
Screening Brief Intervention and Referral to Treatment (SBIRT) approach. The
brief intervention component is based on cognitive behavioral therapy and
motivational interviewing techniques.
Study burden and risks
Burden associated with the study is expected to be limited as the complete
study will take place over the internet. The 6 week, 3- and 6-month
post-randomisation questionnaires will be as short as possible. Participants
only need a smartphone for all interactions (research and training) and can
access the training whenever it suits them.
The control group receives information regarding cannabis moderation/cessation.
The experimental group will receive access to an online self-help
program/training which focuses on reducing cannabis use. Participants will be
randomised to either condition (control/experimental) which may induce
inconvenience. They are fully informed about the randomisation procedure before
providing consent to participate in the study. Participants are provided with a
phone number and email address if they would like to ask a question related to
the study. For medical questions or emergencies, the primary contact person
will be their family doctor.
A potential risk associated with the intervention are mild withdrawal symptoms,
for example craving. Information about withdrawal symptoms will be provided in
both interventions (experimental and control).
The benefits of the training are a better understanding of one*s cannabis
smoking behaviour and help-seeking behaviour. The benefit for the study
population is that through acquiring knowledge regarding the effectiveness of
internet-based self-help and referral to treatment, healthcare for cannabis
users can be improved. All in all, we think those benefits outweigh the limited
risks associated with this study.
Da Costakade 45
Utrecht 3521 VS
NL
Da Costakade 45
Utrecht 3521 VS
NL
Listed location countries
Age
Inclusion criteria
-Age 18+
-Cannabis use on 3 or more days a week in the past month
-Desire to reduce or quit cannabis use
-Smartphone available
-Ability and intention to participate in the intervention and study for the
period of 6 months
-Informed consent provided
Exclusion criteria
-Formal treatment (psycho-social or pharmacological) for cannabis use or any
other substance use in the past 3 months
-Insufficient mastery of the Dutch language
-Self-reported suicidal ideation, acute psychosis or severe depression
-Pregnant or lactating
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL67449.100.18 |
| OMON | NL-OMON25559 |