跳至主要内容
临床试验/NCT06561139
NCT06561139招募中不适用

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 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
Region Skane
入组人数
60
试验地点
1
主要终点
Change in past 30-day gambling (NODS 30 days)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

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.

干预措施: Mindfulness (Behavioral)

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.

干预措施: Mindfulness (Behavioral)

结局指标

主要结局

Change in past 30-day gambling (NODS 30 days)

时间窗: 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

次要结局

  • 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)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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