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Clinical Trials/NCT06561139
NCT06561139RecruitingNot Applicable

Mindfulness as an add-on Intervention in Treatment for Problem Gambling - a Randomized Control Trial and a Qualitative Analysis in Clinical Settings in Sweden

Region Skane1 site in 1 country60 target enrollmentStarted: August 15, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Change in past 30-day gambling (NODS 30 days)

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 informed consent

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change in past-2-week depressive symptoms(Post-treatment (treatment completion) and 3 and 12 months after end of treatment)
  • Change in past-2-week anxiety symptoms(Post-treatment (treatment completion) and 3 and 12 months after end of treatment)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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