Internet-based Cognitive Behavioral Treatment for Gambling Disorder - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- The Gambling Symptom Assessment Scale
研究概览
简要总结
The study is a randomized controlled trial (Total N=150; each condition n=75) of internet-based cognitive behavioral therapy (iCBT), with measures at pre, weekly during treatment, post, three and at six month follow-up. Participants will be assigned to either standard iCBT and "Spelpaus" (treatment condition), or "Spelpaus" only (control condition).
详细描述
Recruitment will be done through online advertisement via social media and gambling-related websites. Participants will self-referred to the study via a study dedicated website (www.spelstudien.se). Login to a treatment platform will be verified using double authentication (detailed description of the online platform is provided in the application to the Swedish Ethical Review Authority). Written information about the study will be provided on the web page. Consent will be done online, with the possibility for participants to download study information and consent. Consenting participants will start a screening procedure. After screening, participants will be contacted for a telephone assessment with a clinical psychologist. During this interview, participants will be assessed for GD with a diagnostic interview, as well as the inclusion criteria for utilization of "Spelpaus". If meeting criteria for the study, participants will be referred to the baseline/pre-measures - which will start with an additional informed consent for the treatment phase and the iCBT. Inclusion will be done after the completion of the informed consent and baseline/pre-measures. After that, participant will be randomized to iCBT and "Spelpaus" (treatment condition), or "Spelpaus" only (control condition). Randomization will be conducted by a third party using a true random service, https://random.org. Participants assigned to the control condition in the randomized controlled trial will receive a voucher of total 1000 Swedish Krona's when completing the post and follow up measures. Participants assigned to the control condition in the randomized controlled trial will receive a voucher of total 1000 Swedish Krona's when completing the post and follow up measures.
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
- •Screen positive for GD, as measured with the Gambling Disorder Identification Test (total score ≥20 GDIT).
- •Fulfilling GD, assessed according to the Structured Clinical Interview for Gambling Disorder (SCI-GD).
- •Utilization of "Spelpaus", 3 months from treatment start.
- •≥18 years of age.
- •Able to provide digital informed consent.
排除标准
- •Other ongoing psychological treatment for GD.
- •Severe depression, screened according to the Montgomery Åsberg Depression Rating Scale (total score >34 MADRS-S).
- •Suicidality, screening of ≥4 points on item 9 of the MADRS-S
研究组 & 干预措施
"Spelpaus" (gambling self-exclusion)
"Spelpaus" only - a self-exclusion gambling service.
Internet-based cognitive behavioral therapy (iCBT)
An 8-module internet-delivered cognitive behavioral therapy program. Participants receiving treatment will simultaneously use "Spelpaus" - a self-exclusion gambling service.
干预措施: Internet-based cognitive behavioral therapy (iCBT) (Behavioral)
结局指标
主要结局
The Gambling Symptom Assessment Scale
时间窗: 6 month after treatment cessation
Primary outcome will be gambling symptoms, measured with the the Gambling Symptom Assessment Scale. Minimum score is 0 and maximum score is 48, with higher scores indicated higher frequency of gambling symptoms.
次要结局
- The TimeLine Followback for gambling(6 month after treatment cessation)
- The Generalized Anxiety Disorder 7-itemscale(6 month after treatment cessation)
- The Patient Health Questionnaire(6 month after treatment cessation)
- The Drug Use Disorders Identification Test(6 month after treatment cessation)
- The Alcohol Use Disorders Identification Test(6 month after treatment cessation)
研究者
Olof Molander
Principal Investigator
Karolinska Institutet