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

NCT06561139 | Recruiting

• 1 other identifier: Mindfulness gambling study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Problem Gambling

Keywords

Problem gambling; Mindfulness

Outcome Measures

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

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

Secondary Outcomes (2)

• 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

Study Arms (2)

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.

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.

Behavioral: Mindfulness

Interventions

Mindfulness BEHAVIORAL

Weekly group sessions of mindfulness, for eight weeks

Control: treatment as usual + waiting list for two months; Intervention: treatment as usual + group mindfulness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

Malmö Addiction Center

Malmo, Sweden

RECRUITING

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Anders Håkansson, PhD

CONTACT

+46 46 175596; anders_c.hakansson@med.lu.se

Patrick Bacquin, nurse

CONTACT

patrick.bacquin@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial, and subsequently a qualitative study

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 19, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)