ClinicalTrials.gg
RecruitingNCT06561139Updated Aug 21, 2024

Mindfulness as an add-on Intervention in Treatment for Problem Gambling in Clinical Settings in Sweden

An interventional study of Mindfulness in Problem Gambling, sponsored by Region Skane. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by Region Skane · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Problem Gambling

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Keywords

  • Problem gambling
  • Mindfulness
03

In context

Gambling

158 studies on the registry are indexed under Gambling; 42 are open to participants now.

This study's planned enrollment of 60 is close to the median of 66 across 128 interventional studies indexed under Gambling.

Browse Gambling studies →

Lead sponsor

Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Inability to provide 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Intervention: treatment as usual + group mindfulness

    Eight-week, weekly group sessions of mindfulness, as an add-on to treatment as usual for problem gambling.

    Behavioral: Mindfulness

  • Active comparator
    Control: treatment as usual + waiting list for two months

    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.

    Behavioral: Mindfulness

Interventions

  • BehavioralMindfulness

    Weekly group sessions of mindfulness, for eight weeks

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Post-treatment (treatment completion) and 3 and 12 months after end of treatment

Secondary outcomes

  1. 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

    Time frame: Post-treatment (treatment completion) and 3 and 12 months after end of treatment

  2. 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

    Time frame: Post-treatment (treatment completion) and 3 and 12 months after end of treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06561139
Lead sponsor
Region Skane
Collaborators
Lund University
Responsible party
Sponsor
First posted
Aug 19, 2024
Start date
Aug 15, 2024
Primary completion
Aug 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 21, 2024

Study contacts

Anders Håkansson, PhD
Contact
anders_c.hakansson@med.lu.se
+46 46 175596
Patrick Bacquin, nurse
Contact
patrick.bacquin@skane.se

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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