Gambling DisorderNCT06099522
Internet-CBT for Gambling Disorder - a Randomized Controlled Trial
A study testing Internet-based cognitive behavioral therapy (iCBT) in people with Gambling Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The study is a randomized controlled trial (Total N=150; each condition n=75) of internet-based cognitive behavioral therapy (iCBT), with measures at pre, weekly during treatment, post, three and at six month follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gambling Disorder
- What is being tested?
- Internet-based cognitive behavioral therapy (iCBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jan 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Screen positive for GD, as measured with the Gambling Disorder Identification Test (total score ≥20 GDIT).
- Fulfilling GD, assessed according to the Structured Clinical Interview for Gambling Disorder (SCI-GD).
- Utilization of "Spelpaus", 3 months from treatment start.
- ≥18 years of age.
- Able to provide digital informed consent.
Who cannot join
- Other ongoing psychological treatment for GD.
- Severe depression, screened according to the Montgomery Åsberg Depression Rating Scale (total score >34 MADRS-S).
- Suicidality, screening of ≥4 points on item 9 of the MADRS-S
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Centre for psychiatry research
Stockholm, 116 30
Olof Molander, 0700011241, olof.molander@ki.se
About this study
Official title: Internet-based Cognitive Behavioral Treatment for Gambling Disorder - a Randomized Controlled Trial
The study is a randomized controlled trial (Total N=150; each condition n=75) of internet-based cognitive behavioral therapy (iCBT), with measures at pre, weekly during treatment, post, three and at six month follow-up. Participants will be assigned to either standard iCBT and "Spelpaus" (treatment condition), or "Spelpaus" only (control condition).
Read the detailed description
Recruitment will be done through online advertisement via social media and gambling-related websites. Participants will self-referred to the study via a study dedicated website (www.spelstudien.se). Login to a treatment platform will be verified using double authentication (detailed description of the online platform is provided in the application to the Swedish Ethical Review Authority). Written information about the study will be provided on the web page. Consent will be done online, with the possibility for participants to download study information and consent. Consenting participants will start a screening procedure. After screening, participants will be contacted for a telephone assessment with a clinical psychologist. During this interview, participants will be assessed for GD with a diagnostic interview, as well as the inclusion criteria for utilization of "Spelpaus". If meeting criteria for the study, participants will be referred to the baseline/pre-measures - which will start with an additional informed consent for the treatment phase and the iCBT. Inclusion will be done after the completion of the informed consent and baseline/pre-measures. After that, participant will be randomized to iCBT and "Spelpaus" (treatment condition), or "Spelpaus" only (control condition). Randomization will be conducted by a third party using a true random service, https://random.org. Participants assigned to the control condition in the randomized controlled trial will receive a voucher of total 1000 Swedish Krona's when completing the post and follow up measures. Participants assigned to the control condition in the randomized controlled trial will receive a voucher of total 1000 Swedish Krona's when completing the post and follow up measures.
- Conditions
- Gambling Disorder
- Being tested
- Internet-based cognitive behavioral therapy (iCBT)
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based cognitive behavioral therapy (iCBT)Behavioural
The treatment is a newly developed iCBT 8 module program, with interventions targeting gambling-related loss of control, through 4 clinical processes: Gambling triggers, Gambling-related anticipation, the Gambling zone and Chasing behaviors. The treatment will be delivered with therapist support.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based cognitive behavioral therapy (iCBT) | Experimental | An 8-module internet-delivered cognitive behavioral therapy program. Participants receiving treatment will simultaneously use "Spelpaus" - a self-exclusion gambling service. Receives: Behavioral: Internet-based cognitive behavioral therapy (iCBT) |
| "Spelpaus" (gambling self-exclusion) | No intervention | "Spelpaus" only - a self-exclusion gambling service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Gambling Symptom Assessment Scale
Primary outcome will be gambling symptoms, measured with the the Gambling Symptom Assessment Scale. Minimum score is 0 and maximum score is 48, with higher scores indicated higher frequency of gambling symptoms.
Measured: 6 month after treatment cessation
Secondary outcomes (5)
The TimeLine Followback for gambling
Gambling behavior (days per week gambled) will be measured with a self-report item adapted from the TimeLine Followback for gambling.
Measured: 6 month after treatment cessation
The Generalized Anxiety Disorder 7-itemscale
Anxiety symptoms will be measured by the Generalized Anxiety Disorder 7-itemscale.
Measured: 6 month after treatment cessation
The Patient Health Questionnaire
Depressive symptoms will be measured with the The Patient Health Questionnaire.
Measured: 6 month after treatment cessation
The Alcohol Use Disorders Identification Test
Alcohol problems will be measured with the Alcohol Use Disorders Identification Test.
Measured: 6 month after treatment cessation
The Drug Use Disorders Identification Test
Drug problems will be measured with the Drug Use Disorders Identification Test.
Measured: 6 month after treatment cessation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start15 Jan 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gambling DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to either standard iCBT and "Spelpaus" (treatment condition), or "Spelpaus" only (control condition).
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Deakin University
- Responsible party
- Principal investigator, Olof Molander, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099522
- Sponsor's protocol ID
- Dnr 2023-01075-01
- Status last verified
- Mar 2024
- First submitted
- 29 Aug 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavioral Treatment for Gambling Disorder - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06099522
- Acronym / sponsor ID
- Dnr 2023-01075-01
- Conditions
- Gambling Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Deakin University
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a randomized controlled trial (Total N=150; each condition n=75) of internet-based cognitive behavioral therapy (iCBT), with measures at pre, weekly during treatment, post, three and at six month follow-up. Participants will be assigned to either standard iCBT and "Spelpaus" (treatment condition), or "Spelpaus" only (control condition).
Detailed description
Recruitment will be done through online advertisement via social media and gambling-related websites. Participants will self-referred to the study via a study dedicated website (www.spelstudien.se). Login to a treatment platform will be verified using double authentication (detailed description of the online platform is provided in the application to the Swedish Ethical Review Authority). Written information about the study will be provided on the web page. Consent will be done online, with the possibility for participants to download study information and consent. Consenting participants will start a screening procedure. After screening, participants will be contacted for a telephone assessment with a clinical psychologist. During this interview, participants will be assessed for GD with a diagnostic interview, as well as the inclusion criteria for utilization of "Spelpaus". If meeting criteria for the study, participants will be referred to the baseline/pre-measures - which will start with an additional informed consent for the treatment phase and the iCBT. Inclusion will be done after the completion of the informed consent and baseline/pre-measures. After that, participant will be randomized to iCBT and "Spelpaus" (treatment condition), or "Spelpaus" only (control condition). Randomization will be conducted by a third party using a true random service, https://random.org. Participants assigned to the control condition in the randomized controlled trial will receive a voucher of total 1000 Swedish Krona's when completing the post and follow up measures. Participants assigned to the control condition in the randomized controlled trial will receive a voucher of total 1000 Swedish Krona's when completing the post and follow up measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to either standard iCBT and "Spelpaus" (treatment condition), or "Spelpaus" only (control condition).
| Arm | Type | Receives |
|---|---|---|
| Internet-based cognitive behavioral therapy (iCBT) | Experimental | Behavioral: Internet-based cognitive behavioral therapy (iCBT)An 8-module internet-delivered cognitive behavioral therapy program. Participants receiving treatment will simultaneously use "Spelpaus" - a self-exclusion gambling service. |
| "Spelpaus" (gambling self-exclusion) | No intervention | –"Spelpaus" only - a self-exclusion gambling service. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Screen positive for GD, as measured with the Gambling Disorder Identification Test (total score ≥20 GDIT).
- Fulfilling GD, assessed according to the Structured Clinical Interview for Gambling Disorder (SCI-GD).
- Utilization of "Spelpaus", 3 months from treatment start.
- ≥18 years of age.
- Able to provide digital informed consent.
Key exclusion criteria (3 listed)
- Other ongoing psychological treatment for GD.
- Severe depression, screened according to the Montgomery Åsberg Depression Rating Scale (total score >34 MADRS-S).
- Suicidality, screening of ≥4 points on item 9 of the MADRS-S
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based cognitive behavioral therapy (iCBT)The treatment is a newly developed iCBT 8 module program, with interventions targeting gambling-related loss of control, through 4 clinical processes: Gambling triggers, Gambling-related anticipation, the Gambling zone and Chasing behaviors. The treatment will be delivered with therapist support. | Behavioural | Internet-based cognitive behavioral therapy (iCBT) |
Primary outcome
The Gambling Symptom Assessment Scale
Time frame: 6 month after treatment cessation
Primary outcome will be gambling symptoms, measured with the the Gambling Symptom Assessment Scale. Minimum score is 0 and maximum score is 48, with higher scores indicated higher frequency of gambling symptoms.
5 secondary outcomes
The TimeLine Followback for gambling
Time frame: 6 month after treatment cessation
The Generalized Anxiety Disorder 7-itemscale
Time frame: 6 month after treatment cessation
The Patient Health Questionnaire
Time frame: 6 month after treatment cessation
The Alcohol Use Disorders Identification Test
Time frame: 6 month after treatment cessation
The Drug Use Disorders Identification Test
Time frame: 6 month after treatment cessation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based cognitive behavioral therapy (iCBT) in people with Gambling Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olof Molander, PhD (0700011241, olof.molander@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Gambling Symptom Assessment Scale (time frame: 6 month after treatment cessation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.