Condition category
Mental and Behavioural Disorders
Date applied
06/02/2019
Date assigned
07/02/2019
Last edited
18/03/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

www.winbackcontrol.ch

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

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

01/12/2020

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

01/09/2020

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

http://www.isgf.uzh.ch

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

01/03/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/03/2019: The primary outcome measure was updated.