Plain English Summary
Background and study aims
Cannabis is a popular recreational drug used all over the world, only behind alcohol, caffeine and tobacco. It can be addictive and cause mental health problems and lung damage. The therapist-guided web-based programme Quit the Shit (QTS) offers free and anonymous support for people who want to stop using cannabis, or reduce their intake. Previous research has shown that the programme is effective at reducing peoples cannabis use and so we now want to study the program effects more closely. We are especially interested in the effects of two main features of the program its duration and the therapist-guided chat.
Who can participate?
The study aims at German speaking cannabis users who want to cease or reduce their consumption and who are at least 18 years old, are not alcohol dependent, do not have a mental health problem, have not used other illicit drugs on more than 4 occasions in the last 30 days, are not suicidal and, finally, have not participated in the programme before.
What does the study involve?
After registering with the study, all participants fill out the baseline questionnaire of the study. It is presented online on the website of the program (https://www.quit-the-shit.net). The eligibility criteria are checked in the baseline questionnaire. To begin the programme, all participants pick an appointment to start. When logging into their user account at the scheduled appointment, they are randomized to one of four study groups: a) 28 days program duration without therapist-guided chat, b) 50 days program duration without therapist-guided chat, c) 28 days program duration with at least one therapist-guided chat, d) 50 days program duration with at least one therapist-guided chat. All participants have access to an online cannabis use-diary and up to six different online exercises aiming to improve their coping skills. Every week, each participant receives a detailed feedback from a trained psychologist on their journal entries.
What are the possible benefits and risks of participating?
All participants gain access to professional, free of charge and anonymous support to help them reduce their cannabis use. The support is provided by trained and experienced psychotherapists. Thus we assume that participants of all four study groups will benefit by reducing their cannabis use and by increasing their drug-related coping strategies. We do not see any noteworthy risks in participating.
Where is the study run from?
The study is fully internet based. It runs on the website www.quit-the-shit.net, owned by the German Federal Centre for Health Education (BZgA).
When is the study starting and how long is it expected to run for?
August 2014 to February 2016
Who is funding the study?
German Federal Centre for Health Education (BZgA), Germany
Who is the main contact?
Mr Benjamin Jonas,
jonas@delphi-gesellschaft.de
Trial website
Contact information
Type
Scientific
Primary contact
Mr Benjamin Jonas
ORCID ID
Contact details
Delphi GmbH
Kaiserdamm 8
Berlin
14057
Germany
-
jonas@delphi-gesellschaft.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effects of intervention duration and chat-based intervention in an online cannabis treatment program ("Quit the Shit") - an online randomised controlled trial
Acronym
QTS
Study hypothesis
Both the duration of the program (50 days vs. 28 days) and the provision of at least one therapist-guided chat-session (yes vs. no) increase the effectiveness of a web-based intervention for cannabis users.
Ethics approval
Ethics committee of the Magdeburg Stendal University of Applied Sciences, 29/07/2013, ref. AZ 4973-35
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
https://www.quit-the-shit.net/qts/downloads/QTS_Studieninformationen.pdf
Condition
Cannabis use disorder
Intervention
Study participants are randomized to one of four groups
1. 28 days duration without therapist-guided chat
2. 50 days duration without therapist-guided chat
3. 28 days duration with at least one therapist-guided chat
4. 50 days duration with at least one therapist-guided chat
All participants have access to an online cannabis use-diary and up to six different online exercises aiming to improve their coping skills. Every week, each participant receives a detailed feedback from a trained psychologist on their journal entries.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Cannabis use days during the last 30 days
2. Cannabis use amount (grams) during the last 30 days
Secondary outcome measures
1. Severity of Dependence Scale SDS
2. Cannabis Craving Scale CCS-7
Overall trial start date
18/08/2014
Overall trial end date
15/11/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Minimum age 18 years
2. Currently no alcohol use disorder (score of less than 3 in the CAGE instrument), psychotic disorder or bipolar disorder
3. Currently no use of other illicit drugs on more than 4 days during the last 30 days
4. No previous participation at the program
5. No suicidal thoughts
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
552
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
18/08/2014
Recruitment end date
27/02/2016
Locations
Countries of recruitment
Germany
Trial participating centre
Delphi GmbH
Berlin
14057
Germany
Funders
Funder type
Government
Funder name
Federal Centre for Health Education (BZgA) (Germany)
Alternative name(s)
Federal Centre for Health Education, BZgA
Funding Body Type
government organisation
Funding Body Subtype
federal
Location
Germany
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29739738