Internet-based Versus Synchronous Cognitive Behavioural Therapy for Patients With Gambling Disorder: A Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Gambling Problems Past Month as Assessed by The National Opinion Research Center DSM Screen for Gambling Problems (NODS)
研究概览
简要总结
The aim of this two-armed, randomized controlled trial is to determine if internet-based cognitive behavioural therapy (CBT) is as effective as synchronous CBT (sCBT) for treating Gambling Disorder (GD) in adults. The main question it aims to answer is: Is the effect of the internet-based CBT ("SpilleFri") non-inferior to that of synchronous CBT in reducing gambling severity?
The trial will enroll 150 patients with Gambling Disorder who will be randomized (1:1) to either the experimental condition (12 weeks' treatment with the internet-based treatment "SpilleFri") or the active control condition (18 weeks individual sCBT). The primary outcome measure will be based on self-reported GD severity (NODS).
The trial will be considered effective if SpilleFri is not clinically inferior (within a predefined non-inferiority margin) to sCBT in reducing GD severity at the primary endpoint three months after end-of-treatment.
In addition to evaluating the effectiveness of the treatments, the study will conduct an exploratory analysis of the impact of each condition on secondary outcomes (changes in gambling behavior, relationship quality, and symptoms of anxiety, depression, and emotional distress). Similarly, an exploratory analysis of process variables (gambling-related self-efficacy, maladaptive gambling cognitions, emotion regulation difficulties, and gambling urge) will be conducted across conditions and clinical subgroups.
Participants will:
- Engage in nine structured modules of either internet-based CBT or sCBT
- Complete self-reported questionnaires on gambling severity and secondary symptoms at eight time points
- Have the option for up to three additional support sessions with a psychologist
详细描述
PROJECT GROUP: Anna Westh Stenbro (Psychologist, MSc.); Lisbeth Frostholm (Professor, Psychologist, MSc., Ph.D.); David Hodgins (Professor, Psychologist, MSc., Ph.D.)
The trial will be conducted by the research group at the Research Clinic for Gambling Disorder, based at Aarhus University Hospital, Denmark. The clinic was established in 2007 and offers assessment and specialized treatment to patients with GD.
MEASUREMENTS:
Self-reported data from the participants are collected at seven time points: At baseline (T1), randomisation (T2), three time points mid-treatment (T3, T4, T5), end-of-treatment (T6) and at 3-month follow-up (T7, primary endpoint). Due to different treatment durations in the two arms, an additional measurement point (T7b) is added to control for the effect of time for participants in the SF group, at the time point when participants in the sCBT group complete the 3-month follow-up (week 30). At T6, all participants will be invited to participate in a 12-month follow-up study (T8).
During treatment, therapists register the length, and themes, of phone conversations and face-to-face sessions in SpilleFri and equally the length and overall themes of sessions in the sCBT arm. In both arms, therapists register involvement of concerned significant others in treatment sessions. In the sCBT arm, therapist register manual fidelity and covered intervention topics after each session. Deviations are described. At the end of the treatment course, the therapists evaluate participant engagement and treatment effect (CGI-I).
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
- •To be included patients should:
- •fulfil diagnostic criteria for GD (DSM-5).
- •score 4 points or more on the National Opinion Research Centre Screen for Gambling Problems (NODS).
- •be able to read, write, and speak Danish.
- •have IT skills and access to the internet and a computer, smartphone, and/or tablet.
排除标准
- •Patients are excluded from participation if they:
- •present with severe comorbid somatic disease, cognitive deficits, severe trauma, and/or psychiatric disorder (e.g. depression, bipolar disorder, substance abuse, ADHD) that is insufficiently treated at the time of assessment and/or is evaluated to constitute a barrier for engaging in or benefitting from treatment.
- •are not willing to engage in internet-delivered treatment or face-to-face cognitive behavioural therapy.
- •do not provide informed consent.
- •are in risk of suicide (indicated by clear intent and/or plans).
- •have previously received treatment via or had access to the SpilleFri platform.
- •seek treatment as part of an imminent legal case.
- •only fulfil diagnostic criteria for Gambling Disorder in relation to behaviour such as stock trading or buying and selling cryptocurrency.
- •present with highly unstable social circumstances, which are considered to potentially pose a barrier to engaging in treatment (e.g., homelessness).
研究组 & 干预措施
Internet-based cognitive behavioral therapy ("SpilleFri")
Participants in this arm receive internet-based cognitive behavioral therapy via the therapist-guided online treatment platform "SpilleFri"
干预措施: Internet-based cognitive behavioral therapy (Behavioral)
Synchronous cognitive behavioral therapy (sCBT)
Participants in this arm receive traditional synchronous cognitive behavioral therapy, face-to-face or via video-connection
干预措施: Synchronous cognitive behavioral therapy (Behavioral)
结局指标
主要结局
Change in Gambling Problems Past Month as Assessed by The National Opinion Research Center DSM Screen for Gambling Problems (NODS)
时间窗: Baseline, 12 weeks/18 weeks (post treatment SpilleFri/sCBT), 24 weeks/30 weeks (3 month FU SpilleFri/sCBT), 64 weeks/70 weeks (12 month FU SpilleFri/sCBT)
Measured by Danish translation of The National Opinion Research Center Screen for Gambling Problems (NODS). 17 items with a minimum score of 0 and a maximum score of 10, with higher scores meaning more servere gambling problems. Self-report measure collected through a web-based questionnaire program. For the purpose of the study, the NODS is modified to assess the last month instead of the last year.
次要结局
- Change in Gambling Symptoms past week as Assessed by Gambling Symptom Assessment Scale (G-SAS)(Baseline, during treatment (weeks 4, 7, 10), post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70))
- Change in Self-reported Gambling Net Loss past week as assessed by a single item(Baseline, during treatment (weeks 4, 7, 10), post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70))
- Overall health improvement(Post (week 12/18, clinician rating), 3 month FU (week 24/30, participant and clinician rating))
- Change in Symptoms of anxiety, depression, and psychological distress as Assessed by th SCL-90(Baseline, post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70))
- Change in Overall Quality of Life and General Health Satisfaction as Assessed by the WHOQoL(Baseline, post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70))
- Change in Quality of Current Romantic Relationship as Assessed by the DAS-4(Baseline, post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70))
- Participant treatment expectancy and satisfaction as Assessed by the Experienced Treatment Credibility and Expectancy(Baseline and post (week 12/18))
研究者
Lisbeth Frostholm
Professor
Aarhus University Hospital