Condition category
Mental and Behavioural Disorders
Date applied
17/06/2014
Date assigned
27/06/2014
Last edited
26/11/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

https://www.quit-the-shit.net

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 measures

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

27/02/2016

Reason abandoned

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

Sponsor information

Organisation

Federal Centre for Health Education (BZgA) (Germany)

Sponsor details

Ostmerheimer Str. 220
Köln
51109
Germany

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes