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临床试验/NCT02250586
NCT02250586已完成不适用

Internet Based Cognitive-behavioral Therapy for Concerned Significant Others of Problem Gamblers: a Randomized Wait-list Controlled Trial

Stockholm University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Inventory of Consequences Scale for the Gambler and CSO

研究概览

简要总结

BACKGROUND: About 2.3 % of the adult population in Sweden is considered to be problem gamblers, and it is estimated that only 5 % of them seek treatment. Problem gambling can have devastating effects on the economy, health and relationship, both for the problem gambler and their concerned significant other (CSO). No empirically supported program exists for the CSOs of problem gamblers. Consequently, the aim of this study is to develop and evaluate a program aimed at CSOs of treatment refusing problem gamblers. The program will be based on principles from cognitive behavioral therapy and motivational interviewing. In order to benefit as many CSOs as possible, the program will be delivered via the Internet with therapist support via email and telephone.

METHODS/DESIGN: This will be a randomized wait-list controlled internet-delivered trial. A cognitive behavioral-therapy program for the concerned significant others (CSOs) of problem gamblers (PGs) will be developed and evaluated. The participants will work through 8 modules over 10 weeks in a secure online environment, and receive support via text messages and over telephone. 150 CSOs over 18 years of age will be included. Measures will be taken at baseline 3, 6 and 12 months. Primary outcomes concern gambling-related harm and motivating the PG to seek treatment. Secondary outcomes are CSO's feelings of depression, anxiety, relationship satisfaction and quality of life.

HYPOTHESIS: The investigators hypothesize: 1) that the CBT-CSO group will lead to a reduction in gambling related harm experienced by the CSO, 2) the CBT-CSO program will reduce the CSO's anxiety and depressive feelings, 3) the CBT-CSO program will decrease the amount of time and money the problem gambler spend on gambling, 4) the CBT-CSO program will increase the CSO's relationship satisfaction with the problem gambler.

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

入选标准

  • The CSO and the gambler are at least 18 years old,
  • The CSO is a parent, child, sibling, friend or partner of the gambler.
  • The CSO must have had a relationship with the gambler for at least 3 months.
  • Neither the CSO nor the gambler has had any treatment in the past 3 months (that is related to gambling).
  • The gambler is currently refusing help.
  • The CSO is able to read and answer questions in Swedish, and is willing to talk to a counselor each week.
  • The gambler is a problem gambler according to Problem Gambling Severity Index, as rated by the CSO.
  • The CSO must agree to have their telephone calls recorded.

排除标准

  • Presence of psychotic- or bipolar disorder in the CSO or gambler.
  • CSO meets PGSI criteria for ongoing problem gambling.

结局指标

主要结局

Inventory of Consequences Scale for the Gambler and CSO

时间窗: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.

次要结局

  • 9-item Patient Health Questionnaire (PHQ-9)(Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.)
  • Timeline followback method(Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.)
  • The Generalised Anxiety Disorder 7-item (GAD-7)(Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.)
  • Relationship Assessment Scale (generic version)(Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.)
  • WHO Quality of Life Questionnaire-Bref(Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.)
  • Treatment engagement(Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.)

研究者

发起方
Stockholm University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Per Carlbring

Professor

Stockholm University

研究点 (1)

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