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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Study website

Contact information

Mr Benjamin Jonas
Scientific

Delphi GmbH
Kaiserdamm 8
Berlin
14057
Germany

Email jonas@delphi-gesellschaft.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet https://www.quit-the-shit.net/qts/downloads/QTS_Studieninformationen.pdf
Scientific titleEffects of intervention duration and chat-based intervention in an online cannabis treatment program ("Quit the Shit") - an online randomised controlled trial
Study acronymQTS
Study objectivesBoth 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) studiedCannabis use disorder
InterventionStudy 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 typeOther
Primary outcome measure1. Cannabis use days during the last 30 days
2. Cannabis use amount (grams) during the last 30 days
Secondary outcome measures1. Severity of Dependence Scale SDS
2. Cannabis Craving Scale CCS-7
Overall study start date18/08/2014
Completion date15/11/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants552
Total final enrolment534
Key inclusion criteria1. 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 criteriaDoes not meet inclusion criteria
Date of first enrolment18/08/2014
Date of final enrolment27/02/2016

Locations

Countries of recruitment

  • Germany

Study participating centre

Delphi GmbH
Berlin
14057
Germany

Sponsor information

Federal Centre for Health Education (BZgA) (Germany)
Government

Ostmerheimer Str. 220
Köln
51109
Germany

ROR logo "ROR" https://ror.org/054c9y537

Funders

Funder type

Government

Federal Centre for Health Education (BZgA) (Germany)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.