The Effect of a Brief Intervention for Problem Gamblers - a Randomized Controlled
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Participant rated satisfaction with the treatment at large
研究概览
简要总结
A pragmatic randomized pilot trial primarily examining the feasibility of a brief therapist guided online self-help program based on Cognitive behavioral therapy (CBT). Participants will be randomized to either a treatment as usual condition (TAU) or to TAU plus CBT.
详细描述
The current study is a pragmatic randomized pilot trial examining the feasibility and effects of a brief therapist guided online self-help program based on Cognitive behavioral therapy (CBT) . Participants will be randomized to either a treatment as usual condition (TAU) or to TAU plus CBT.
Participants will be recruited via the Swedish national gambling helpline. After assessment for eligibility participants will be randomized, using block randomization to ensure balanced groups, to either TAU or TAU+CBT.
The participants will be measured; at baseline, weekly during the intervention (6 weeks), immediately after the intervention and at 6 weeks after treatment termination. Informed consent will be collected prior any data collection.
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
- Single (Outcomes Assessor)
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
- •≥ 18 years
- •Experiencing gambling problems (PGSI ≥ 3 p)
- •Good enough knowledge in Swedish
- •Access to a smart phone or computer with internet connection
排除标准
- •Being involved in another treatment study the previous 3 months
- •Other concurrent treatment for gambling problems
- •Being on a non-stable pharmacological treatment for any psychiatric condition
- •Severe depression defined as a PHQ-9 score of 20 points or more
研究组 & 干预措施
Treatment as usual
The TAU condition consists of a single session of regular help-line telephone counselling
干预措施: Regular help-line telephone counselling (Behavioral)
Cognitive behavioral therapy
The experimental condition consists of a single session of regular help-line telephone counselling plus four therapist guided online CBT sessions.
干预措施: Cognitive behavioral therapy (CBT) (Behavioral)
结局指标
主要结局
Participant rated satisfaction with the treatment at large
时间窗: immediately after the intervention.
Participant rated satisfaction with the treatment at large will be measured immediately after the intervention using 12 items on a VAS scale ranging from 1 (not at all) to 10 (very). Item 8 answers "yes" or "no" and item 9 is a free-text entry only available if item 8 answers "yes". Items 1- 4 and items 10-12 captures satisfaction with the program and items 5 - 9 captures satisfaction with the therapist.
Participant rated satisfaction with the treatment protocol
时间窗: measured in conjunction with each online treatment module for up to six weeks (at four occasions)
Participant rated satisfaction with the treatment protocol will be measured using three items at the end of each online treatment module. The items are measured on a VAS scale ranging from 1-5 (1= not at all, 5 = very). Item 1) "How helpful do you think the content of this module has been?" Item 2) "How well does the content of the module fit the problems you experience and want help with?" Item 3) "What grade from 1 to 5 would you give this module?
Retention at the end of the study
时间窗: 6-weeks after the intervention
Retention, defined as proportion of participants who fill out the last follow-up survey
Time for execution of the study
时间窗: from the date of the first included participant to the last included, assessed up to 52 weeks
Time for execution of the study as measured by the time from the first included participant to the last included,
次要结局
- Timeline follow-back, days gambling and net losses due to gambling(At baseline, weekly during the intervention, immediately after the intervention and at the 6-weeks follow-up)
- Problem Gambling Severity Index (PGSI)(At baseline and at the 6-weeks follow-up)
- National Opinion Research Center Diagnostic and Statistical Manual of Mental Disorders-IV Screen for Gambling (NODS)(At baseline, immediately after the intervention and at the 6-weeks follow-up)
- Drug Use Disorders Identification Test Consumption (DUDIT-C)(At baseline, immediately after the intervention and at the 6-weeks follow-up)
- Generalised Anxiety Disorder 7-item scale (GAD-7)(At baseline, immediately after the intervention and at the 6-weeks follow-up)
- Alcohol Use Disorders Identification Consumption (AUDIT-C)(At baseline, immediately after the intervention and at the 6-weeks follow-up)
- Consumption Screen for Problematic Gambling (CSPG)(At baseline)
- Patient Health Questionnaire-9 (PHQ-9)(At baseline, immediately after the intervention and at the 6-weeks follow-up)
- Gambling Abstinence Self-Efficacy Scale (GASS)(At baseline, immediately after the intervention and at the 6-weeks follow-up)
- World Health Organization Quality of Life Instruments (WHOQOL-BREF)(At baseline, immediately after the intervention and at the 6-weeks follow-up)
- Gambling Urges Scale (GUS)(At baseline, immediately after the intervention and at the 6-weeks follow-up)
研究者
Clara Hellner Gumpert
Professor
Karolinska Institutet