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

August 19, 2024 updated by: Region Skane

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Weekly group sessions of mindfulness, for eight weeks
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
Weekly group sessions of mindfulness, for eight weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Post-treatment (treatment completion) and 3 and 12 months after end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in past-2-week depressive symptoms
Time Frame: Post-treatment (treatment completion) and 3 and 12 months after end of treatment
Change in scores on Patient Health Questionnaire-9, a well-recognised instrument measuring 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
Time Frame: Post-treatment (treatment completion) and 3 and 12 months after end of treatment
Change in scores on Generalised Anxiety Disorder-7, a well-recognised instrument measuring past-2-week anxiety symptoms
Post-treatment (treatment completion) and 3 and 12 months after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Collaborators

Lund University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mindfulness gambling study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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