Effects of intervention duration and chat-based intervention in an online cannabis treatment program
| ISRCTN | ISRCTN99818059 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99818059 |
| Secondary identifying numbers | N/A |
- Submission date
- 17/06/2014
- Registration date
- 27/06/2014
- Last edited
- 02/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Delphi GmbH
Kaiserdamm 8
Berlin
14057
Germany
| jonas@delphi-gesellschaft.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | https://www.quit-the-shit.net/qts/downloads/QTS_Studieninformationen.pdf |
| Scientific title | Effects of intervention duration and chat-based intervention in an online cannabis treatment program ("Quit the Shit") - an online randomised controlled trial |
| Study acronym | QTS |
| Study objectives | 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(s) | Ethics committee of the Magdeburg Stendal University of Applied Sciences, 29/07/2013, ref. AZ 4973-35 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 18/08/2014 |
| Completion date | 15/11/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 552 |
| Total final enrolment | 534 |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 18/08/2014 |
| Date of final enrolment | 27/02/2016 |
Locations
Countries of recruitment
- Germany
Study participating centre
14057
Germany
Sponsor information
Government
Ostmerheimer Str. 220
Köln
51109
Germany
"ROR" |
https://ror.org/054c9y537 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Federal Centre for Health Education, BZgA
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/05/2018 | Yes | No | |
| Other publications | analysis | 26/07/2019 | 02/01/2020 | Yes | No |
Editorial Notes
02/01/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the 2018 reference.
10/05/2018: Publication reference added.
09/02/2017: The overall trial end date was changed from 27/02/2016 to 15/11/2016.
