Problem GamblingNCT06561139
Mindfulness as an add-on Intervention in Treatment for Problem Gambling in Clinical Settings in Sweden
A study testing Mindfulness in people with Problem Gambling, run by Region Skane at 1 site in Sweden.
Trial summary
This study will test the effects of an add-on mindfulness intervention for patients with gambling problems, added to treatment as usual, compared to a waitlist control condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Problem Gambling
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 15 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Enrolled in any kind of treatment for problem gambling at a regional health care unit for problem gambling or at any municipal social service unit for problem gambling, and who provides informed consent
Who cannot join
- Inability to provide informed consent due to language difficulties or due to severe mental health problems, or because of mental health problems requiring urgent psychiatric management (such as suicidal, homicidal, delirious or psychotic behavior)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Patrick Bacquin, nurse contact
Sweden1 site, 1 recruiting
- Recruiting
Malmö Addiction Center
Malmö
Anders Håkansson, PhD, anders.c.hakansson@skane.se
Malin Åkesson, secr, malin.L.akesson@skane.se
About this study
Official title: Mindfulness as an add-on Intervention in Treatment for Problem Gambling - a Randomized Control Trial and a Qualitative Analysis in Clinical Settings in Sweden
This study will test the effects of an add-on mindfulness intervention for patients with gambling problems, added to treatment as usual, compared to a waitlist control condition. The study will primarily aim to decrease gambling behaviour compared to the control condition which receives the intervention later, after two months, and secondarily to decrease symptoms of depressive and anxiety symptoms. In addition, patients who have undergone the mindfulness intervention will be offered participation in a qualitative interview study aiming to deepen the understanding of feasibility and challenges of a mindfulness add-on intervention against gambling problems.
- Conditions
- Problem Gambling
- Being tested
- Mindfulness
- Keywords
- Problem gambling, Mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Weekly group sessions of mindfulness, for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention: treatment as usual + group mindfulness | Experimental | Eight-week, weekly group sessions of mindfulness, as an add-on to treatment as usual for problem gambling. Receives: Behavioral: Mindfulness |
| Control: treatment as usual + waiting list for two months | Active comparator | Treatment as usual for problem gambling and waiting list for the mindfulness condition for two months, after which subjects are offered to undergo the same intervention as in the intervention group. Receives: Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in past 30-day gambling (NODS 30 days)
Change in the number of criteria met according to a diagnostic tool for gambling disorder, but measuring the past 30 days at baseline and at post-treatment, and 3 and 12 months post-treatment
Measured: Post-treatment (treatment completion) and 3 and 12 months after end of treatment
Secondary outcomes (2)
Change in past-2-week depressive symptoms
Change in scores on Patient Health Questionnaire-9, a well-recognised instrument measuring past-2-week depressive symptoms
Measured: Post-treatment (treatment completion) and 3 and 12 months after end of treatment
Change in past-2-week anxiety symptoms
Change in scores on Generalised Anxiety Disorder-7, a well-recognised instrument measuring past-2-week anxiety symptoms
Measured: Post-treatment (treatment completion) and 3 and 12 months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start15 Aug 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (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 Region SkaneThe 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
- Randomized control trial, and subsequently a qualitative study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561139
- Sponsor's protocol ID
- Mindfulness gambling study
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness as an add-on Intervention in Treatment for Problem Gambling - a Randomized Control Trial and a Qualitative Analysis in Clinical Settings in Sweden
- ClinicalTrials.gov ID
- NCT06561139
- Acronym / sponsor ID
- Mindfulness gambling study
- Conditions
- Problem Gambling
- Keywords
- Problem gambling, Mindfulness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Aug 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.
This study will test the effects of an add-on mindfulness intervention for patients with gambling problems, added to treatment as usual, compared to a waitlist control condition. The study will primarily aim to decrease gambling behaviour compared to the control condition which receives the intervention later, after two months, and secondarily to decrease symptoms of depressive and anxiety symptoms. In addition, patients who have undergone the mindfulness intervention will be offered participation in a qualitative interview study aiming to deepen the understanding of feasibility and challenges of a mindfulness add-on intervention against gambling problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial, and subsequently a qualitative study
| Arm | Type | Receives |
|---|---|---|
| Intervention: treatment as usual + group mindfulness | Experimental | Behavioral: MindfulnessEight-week, weekly group sessions of mindfulness, as an add-on to treatment as usual for problem gambling. |
| Control: treatment as usual + waiting list for two months | Active comparator | Behavioral: MindfulnessTreatment as usual for problem gambling and waiting list for the mindfulness condition for two months, after which subjects are offered to undergo the same intervention as in the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Enrolled in any kind of treatment for problem gambling at a regional health care unit for problem gambling or at any municipal social service unit for problem gambling, and who provides informed consent
Key exclusion criteria (1 listed)
- Inability to provide informed consent due to language difficulties or due to severe mental health problems, or because of mental health problems requiring urgent psychiatric management (such as suicidal, homicidal, delirious or psychotic behavior)
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 |
|---|---|---|
| MindfulnessWeekly group sessions of mindfulness, for eight weeks | Behavioural | Control: treatment as usual + waiting list for two months, Intervention: treatment as usual + group mindfulness |
Primary outcome
Change in past 30-day gambling (NODS 30 days)
Time frame: Post-treatment (treatment completion) and 3 and 12 months after end of treatment
Change in the number of criteria met according to a diagnostic tool for gambling disorder, but measuring the past 30 days at baseline and at post-treatment, and 3 and 12 months post-treatment
2 secondary outcomes
Change in past-2-week depressive symptoms
Time frame: Post-treatment (treatment completion) and 3 and 12 months after end of treatment
Change in past-2-week anxiety symptoms
Time frame: Post-treatment (treatment completion) and 3 and 12 months after end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Patrick Bacquin, nurse contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in people with Problem Gambling, run by Region Skane 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 1 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: looking for participants now, as of the sponsor's last update on 21 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anders Håkansson, PhD (+46 46 175596, anders_c.hakansson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in past 30-day gambling (NODS 30 days) (time frame: Post-treatment (treatment completion) and 3 and 12 months after end of treatment). 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 21 Aug 2024.