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临床试验/NCT06107621
NCT06107621Unknown不适用

Internet-based Cognitive Behavioral Therapy for Gambling Disorder and and Comorbidities - a Pilot Study

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
The Gambling Symptom Assessment Scale

研究概览

简要总结

The study is a pilot study (Total N=30), with at pre, weekly during treatment, post and at three-month follow-up.

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 get access to the iCBT.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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.
  • •Classified within pathways 2 or 3, as measured with the Gambling pathways Questionnaire (GPQ).
  • •Screen positive for at least one common mental diagnosis in addition to GD, assessed according to the Web Screening Questionnaire (WSQ).

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

Internet-based iCBT targeting Gambling Disorder and comorbidities

Experimental

An 8 module internet-based iCBT program targeting Gambling Disorder and comorbidities, administered with treatment support.

干预措施: iCBT for Gambling Disorder and psychiatric comorbidities (Behavioral)

结局指标

主要结局

The Gambling Symptom Assessment Scale

时间窗: Six months 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 Generalized Anxiety Disorder 7-itemscale(Six months after treatment cessation)
  • The Alcohol Use Disorders Identification Test(Six months after treatment cessation)
  • The TimeLine Followback for gambling(Six months after treatment cessation)
  • The Patient Health Questionnaire(Six months after treatment cessation)
  • The Drug Use Disorders Identification Test(Six months after treatment cessation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olof Molander

Principal Investigator

Karolinska Institutet

研究点 (1)

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