Plain English Summary
Background and study aims
Switzerland has a wide array of gambling opportunities. The country has 21 casinos and about 9000 lottery-vending points. This makes Switzerland one of the densest countries in the world in terms of gambling places. About half of the adult population has played in the previous year. About 1 percent show signs of problematic gambling. However less than 1 in 10 of problem gamblers are in treatment. Most seek treatment only in response to a significant life crisis. Offering a web-based self-help tool could potentially reach people who otherwise would not seek traditional help.
This study will test the effectiveness of a web-based self-help intervention (programme) compared to a control condition with a self-help manual in reducing gambling activity in problem gamblers.
Who can participate?
Adults (aged at least 18), able to read and write in German or French and have gambled at least once a week during the last 30 days
What does the study involve?
Participants are randomly allocated to one of two groups. The intervention group is given access to the web-based self-help program (Win Back Control). The active control condition will receive a copy of a self-help manual which has been proven effective in other studies. Win Back Control consists of a gambling diary, nine modules designed to help people to reduce their gambling based on the principles of motivational interviewing, self-control practices, and methods of cognitive behavioural therapy. The participants are encouraged to complete as many modules as possible during the 8-week program duration.
All participants are followed up 16 weeks after the program ends to see whether they have reduced their gambling activity.
What are the possible benefits and risks of participating?
A possible benefit to participation is reducing one’s own gambling. Possible risks include experiencing mild cravings and depression.
Where is the study run from?
Research Institute for Public Health and Addiction (ISGF) (Switzerland)
When is the study starting and how long is it expected to run for?
March 2019 to December 2020
Who is funding the study?
This project is co-financed by the 16 SOS-Spielsucht-Cantons, Gesundheitsförderung Schweiz and the Canton of Zurich.
Who is the main contact?
Mr Christian Baumgartner, christian.baumgartner@isgf.uzh.ch
Trial website
Contact information
Type
Scientific
Primary contact
Mr Christian Baumgartner
ORCID ID
http://orcid.org/0000-0002-5570-7607
Contact details
Konradstrasse 32
Zurich
8005
Switzerland
+41 44 448 11 60
christian.baumgartner@isgf.uzh.ch
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
SNCTP000003127
Study information
Scientific title
Developing and piloting of a web-based self-help tool for problem gambling in Switzerland: Win Back Control
Acronym
WBC
Study hypothesis
The web-based intervention will be more effective than the control condition in reducing gambling among problematic gamblers.
We have the following expectations with respect to the secondary outcomes between the baseline, 8-week follow up, and 24-weeks follow up:
1. Severity of gambling is more reduced in participants from study arm 1 than those in study arm 2 after the 8 weeks of intervention and at 24-weeks follow up.
2. Participants in study arm 1 demonstrate better improvements with regard to their mental health symptoms than those in study arm 2 at 24-weeks follow up.
3. Participants in study arm 1 decrease their alcohol and nicotine consumption more than those in study arm 2 after the 8 weeks of intervention and at 24-weeks follow up.
4. Participants in the study arm 1 are overall more satisfied with the received intervention than those in study arm 2 after their 8 weeks of intervention.
Ethics approval
Approved 18/12/2018, ethics committee of the Canton of Zurich (Cantonal Ethics Commission Zurich,
Stampfenbachstrasse 121, 8090, Zürich, Switzerland; 043 259 79 72; Info.KEK@kek.zh.ch), ref: BASEC-Nr. 2018-01989
Study design
Two-armed randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Treatment
Patient information sheet
http://www.winbackcontrol.ch/?q=teilnahmeinformationen
Condition
Problematic gambling
Intervention
Participants are randomly allocated to one of two arms:
1. Intervention group: Web-based self-help program
Win Back Control is an automated web-based self-help tool based on classical CBT approaches for treating problematic gambling. It will consist of a gambling diary, nine modules designed to reduce gambling activity based on the principles of motivational interviewing, self-control practices, and methods of cognitive behavioural therapy (“The beginning of change and your goal”, “Risk situations and goal achievement strategies”, “Craving and irrational thoughts”, “Tackling problems and dealing with slips”, “Preserve your success”, “Alcohol and nicotine”, “Working on needs”, “Challenging negative thoughts” and “Relaxation and mindfulness”). The core modules (1-5) have to be completed in their intended sequence, complimentary modules will be unrestricted from day one.
2. Active control group: Self-help manual
The active control condition will receive a copy of a self-help manual via email, which is based on the principles of motivational interviewing, self-control practices, and methods of cognitive behavioural therapy. The efficacy of the manual has been proven in other studies.
The masking technique is open as masking is not possible in the applied design.
Once participants have completed their baseline assessment, they will be randomized by a computer program in a 1:1 ratio to 1 of 2 groups, and this assignment will be automatically registered in the background database. As participants will see if they have been assigned to the control condition, there is a risk that some might try to circumvent their assignment by registering another account in hope to end up in a different group. In case a participant surmounts the administrative hurdle, he nevertheless will be assigned to the same group for a certain amount of time, based on his IP-address. Measures will be taken at baseline, 8-week follow up, and 24-weeks follow up.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Current primary outcome measure as of 18/03/2019:
Primary outcome variable will the number of days played over last 30 days assessed through self-report questionnaire form at baseline, after 8 weeks and at 24 weeks follow-up.
Previous primary outcome measure:
Primary outcome variable will be the time spent gambling, the number of days per week of play and the amount of money lost assessed through self-report questionnaire form at baseline, after 8 weeks and at 24 weeks follow-up.
Secondary outcome measures
1. Problem gambling severity measured using the PGSI at initial assessment, after 8 weeks and at 24 weeks follow-up.
2. Symptoms of gambling disorder measured using the G-SAS at initial assessment, after 8 weeks and at 24 weeks follow-up.
3. Use of alcohol and tobacco measured using timeline followback forms at initial assessment, after 8 weeks and at 24 weeks follow-up.
4. Depression measured using PHQ-9 at initial assessment and at 24 weeks follow-up.
5. Anxiety measured using GAD-7 at initial assessment and at 24 weeks follow-up.
6. Attention deficit symptoms measured using ASRS-V1.1 at initial assessment and at 24 weeks follow-up.
7. PTSD measured using the Short Screening Scale for DSM-IV Posttraumatic Stress Disorder at initial assessment and at 24 weeks follow-up.
8. Client satisfaction measured using the CSQ-I measured after 8 weeks.
9. Treatment retention measured using consumption diary continuously.
Overall trial start date
01/01/2018
Overall trial end date
01/07/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Gambling activity at least once a week 30 days prior to study entry
2. At least 18 years old
3. Internet access
4. Proficiency in German or French
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
352
Participant exclusion criteria
1. Self-reported engagement in other psychosocial treatments for problem gambling
2. Elevated suicidality (scoring greater than “minimal risk” on a screener
3. Past-90 day psychosis or mania
4. Presence of a severe substance use disorder (SUD)
Recruitment start date
01/03/2019
Recruitment end date
01/01/2021
Locations
Countries of recruitment
Switzerland
Trial participating centre
Swiss Research Institute for Public Health and Addiction
Konradstrasse 32
Zurich
8005
Switzerland
Sponsor information
Organisation
Research Institute for Public Health and Addiction (ISGF)
Sponsor details
Konradstrasse 32
Zurich
8005
Switzerland
+41 44 448 11 60
isgf@isgf.uzh.ch
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Gesundheitsförderung Schweiz
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
16 SOS-Spielsucht-Cantons
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Canton of Zurich
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD Sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
01/09/2021
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 protocol in https://pubmed.ncbi.nlm.nih.gov/31818841/ (added 05/11/2020)