Gambling DisorderNCT06107621
iCBT for GD and Comorbidities - a Pilot
A study testing iCBT for Gambling Disorder and psychiatric comorbidities in people with Gambling Disorder and Comorbidities and Coexisting Conditions, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The study is a pilot study (Total N=30), with at pre, weekly during treatment, post and at three-month follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gambling Disorder, Comorbidities and Coexisting Conditions
- What is being tested?
- iCBT for Gambling Disorder and psychiatric comorbidities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2023to 1 Jun 2024
- 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.
- Classified within pathways 2 or 3, as measured with the Gambling pathways Questionnaire (GPQ).
- Screen positive for at least one common mental diagnosis in addition to GD, assessed according to the Web Screening Questionnaire (WSQ).
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 Therapy for Gambling Disorder and and Comorbidities - a Pilot Study
The study is a pilot study (Total N=30), with at pre, weekly during treatment, post and at three-month follow-up.
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 get access to the iCBT.
- Being tested
- iCBT for Gambling Disorder and psychiatric comorbidities
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCBT for Gambling Disorder and psychiatric comorbiditiesBehavioural
The iCBT, is based on the gambling pathways model. As a clinical conceptualization, the treatment build on loss of control, but also include additional interventions (e.g., emotion regulation and impulse control) targeting the etiological co-morbidity factors in the pathways model for emotionally vulnerable and impulsive gamblers (pathways subtypes 2 and 3).
| Study group | Role | What they receive |
|---|---|---|
| Internet-based iCBT targeting Gambling Disorder and comorbidities | Experimental | An 8 module internet-based iCBT program targeting Gambling Disorder and comorbidities, administered with treatment support. Receives: Behavioral: iCBT for Gambling Disorder and psychiatric comorbidities |
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: Six months 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: Six months after treatment cessation
The Generalized Anxiety Disorder 7-itemscale
Anxiety symptoms will be measured by the Generalized Anxiety Disorder 7-itemscale.
Measured: Six months after treatment cessation
The Patient Health Questionnaire
Depressive symptoms will be measured with the The Patient Health Questionnaire.
Measured: Six months after treatment cessation
The Alcohol Use Disorders Identification Test
Alcohol problems will be measured with the Alcohol Use Disorders Identification Test.
Measured: Six months after treatment cessation
The Drug Use Disorders Identification Test
Drug problems will be measured with the Drug Use Disorders Identification Test.
Measured: Six months 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 posted30 Oct 2023
- Study start1 Dec 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT06107621
- Sponsor's protocol ID
- Dnr 2023-01074-01
- Status last verified
- Mar 2024
- First submitted
- 30 Aug 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 Therapy for Gambling Disorder and and Comorbidities - a Pilot Study
- ClinicalTrials.gov ID
- NCT06107621
- Acronym / sponsor ID
- Dnr 2023-01074-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Deakin University
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 30 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 pilot study (Total N=30), with at pre, weekly during treatment, post and at three-month follow-up.
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 get access to the iCBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet-based iCBT targeting Gambling Disorder and comorbidities | Experimental | Behavioral: iCBT for Gambling Disorder and psychiatric comorbiditiesAn 8 module internet-based iCBT program targeting Gambling Disorder and comorbidities, administered with treatment support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 |
|---|---|---|
| iCBT for Gambling Disorder and psychiatric comorbiditiesThe iCBT, is based on the gambling pathways model. As a clinical conceptualization, the treatment build on loss of control, but also include additional interventions (e.g., emotion regulation and impulse control) targeting the etiological co-morbidity factors in the pathways model for emotionally vulnerable and impulsive gamblers (pathways subtypes 2 and 3). | Behavioural | Internet-based iCBT targeting Gambling Disorder and comorbidities |
Primary outcome
The Gambling Symptom Assessment Scale
Time frame: Six months 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: Six months after treatment cessation
The Generalized Anxiety Disorder 7-itemscale
Time frame: Six months after treatment cessation
The Patient Health Questionnaire
Time frame: Six months after treatment cessation
The Alcohol Use Disorders Identification Test
Time frame: Six months after treatment cessation
The Drug Use Disorders Identification Test
Time frame: Six months 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 iCBT for Gambling Disorder and psychiatric comorbidities in people with Gambling Disorder and Comorbidities and Coexisting Conditions, 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 7 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 (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: Six months 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.