Problem GamblingNCT06230809
Internet Based Self-help for Problem Gambling Concerned Significant Others
A study testing Web-based self-help in people with Problem Gambling, run by Karolinska Institutet.
Trial summary
The project aims to evaluate a brief online self-help intervention for Concerned Significant Others of individuals with Problem Gambling. The intervention consists of five modules with texts, films and exercises and is compared to a waiting list. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Problem Gambling
- What is being tested?
- Web-based self-help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No treatment related to the gambling during the past 3 months for the CSO
- The CSO is at least 18 years old
- The CSO can read and answer questions in Swedish.
- The CSO is assessed as a non-problem gambler according to the Gambling Disorder Identification Test.
Who cannot join
- Displaying symptoms of severe psychiatric disorders such as psychosis or bipolar disease deemed to needed other treatment options.
Trial locations and contacts
No sites are listed yet.
About this study
The project aims to evaluate a brief online self-help intervention for Concerned Significant Others of individuals with Problem Gambling. The intervention consists of five modules with texts, films and exercises and is compared to a waiting list.
- Conditions
- Problem Gambling
- Being tested
- Web-based self-help
- Keywords
- concerned significant others
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based self-helpBehavioural
Web-based self-help with 5 modules, lasting 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Web-based self-help |
| Waitlist | No intervention | Waitlist, participants will be included after 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kessler-9
Mental health
Measured: At baseline and post treatment (5-7 weeks after inclusion) and again 3, 6, and 12 months following treatment completion
Secondary outcomes (6)
Patient Health Questionnaire-9
Depressive symptoms
Measured: At baseline and post treatment (5-7 weeks after baseline) and again 3, 6, and 12 months following treatment completion
Generalized Anxiety Disorder 7-item scale
Anxiety symptoms
Measured: At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Relationship Assessment Scale
Relationship satisfaction
Measured: At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Family Member Impact Scale
Gambling-related family stress
Measured: At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Coping Questionnaire
Coping
Measured: At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Brunnsviken Brief Quality of life quality scale
Quality of life
Measured: At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Dec 2024 (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 Problem GamblingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The National Gambling Helpline Sweden
- Responsible party
- Principal investigator, Anders Nilsson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230809
- Sponsor's protocol ID
- 2023-04225-01
- Other IDs
- 2023
- Status last verified
- Jan 2024
- First submitted
- 2 Oct 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Based Self-help for Problem Gambling Concerned Significant Others
- ClinicalTrials.gov ID
- NCT06230809
- Acronym / sponsor ID
- 2023-04225-01
- Conditions
- Problem Gambling
- Keywords
- concerned significant others
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The National Gambling Helpline Sweden
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 30 Jan 2024 (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 project aims to evaluate a brief online self-help intervention for Concerned Significant Others of individuals with Problem Gambling. The intervention consists of five modules with texts, films and exercises and is compared to a waiting list.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Web-based self-help |
| Waitlist | No intervention | –Waitlist, participants will be included after 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No treatment related to the gambling during the past 3 months for the CSO
- The CSO is at least 18 years old
- The CSO can read and answer questions in Swedish.
- The CSO is assessed as a non-problem gambler according to the Gambling Disorder Identification Test.
Key exclusion criteria (1 listed)
- Displaying symptoms of severe psychiatric disorders such as psychosis or bipolar disease deemed to needed other treatment options.
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 |
|---|---|---|
| Web-based self-helpWeb-based self-help with 5 modules, lasting 5 weeks. | Behavioural | Intervention |
Primary outcome
Kessler-9
Time frame: At baseline and post treatment (5-7 weeks after inclusion) and again 3, 6, and 12 months following treatment completion
Mental health
6 secondary outcomes
Patient Health Questionnaire-9
Time frame: At baseline and post treatment (5-7 weeks after baseline) and again 3, 6, and 12 months following treatment completion
Generalized Anxiety Disorder 7-item scale
Time frame: At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Relationship Assessment Scale
Time frame: At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Family Member Impact Scale
Time frame: At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Coping Questionnaire
Time frame: At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Brunnsviken Brief Quality of life quality scale
Time frame: At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: Yes. IPD will be shared upon reasonable request.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based self-help in people with Problem Gambling, run by Karolinska Institutet.
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 4 inclusion and 1 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Anders Nilsson (+46702235492, anders.nilsson.2@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kessler-9 (time frame: At baseline and post treatment (5-7 weeks after inclusion) and again 3, 6, and 12 months following treatment completion). 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 30 Jan 2024.