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临床试验/NCT05051085
NCT05051085已完成不适用

"SpilleFri" - an Internet-delivered Treatment for Patients With Pathological Gambling. A Feasibility Pilot Study

Anna Westh Stenbro1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Feasibility: Recruitment and retention rate

研究概览

简要总结

This uncontrolled feasibility pilot study explores the feasibility of a 10 week, 8-module, therapist-assisted, internet-delivered treatment program, "SpilleFri", for patients with Pathological Gambling. The study includes 25-30 participants aged 18-60 fulfilling diagnostic criteria for Pathological Gambling (ICD-10). The focus of the feasibility trial is evaluation of treatment response, treatment satisfaction, program utility, recruitment and retention rates, data completion rates, and time requirement. The primary feasibility criterion is 60 % of participants included in the study completing the treatment program.

详细描述

"SpilleFri" - an Internet-delivered Treatment for Patients with Pathological Gambling. A Feasibility Pilot Study

Lisbeth Frostholm & Anna Stenbro

Objective

The objective of this uncontrolled pilot study is to test the feasibility of a future RCT by exploring the feasibility of an internet-delivered treatment program, "SpilleFri", for patients with Pathological Gambling. The focus of the feasibility trial is evaluation of treatment response, treatment satisfaction, program utility, recruitment and retention rates, data completion rates, and time requirement. The primary feasibility criterion is an a priori defined change in patient-rated gambling problems from before to after treatment.

Design

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 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Meet the diagnostic criteria for Pathological Gambling (ICD-10)
  • •Able to read, wright, and speak Danish to a degree that enables interaction with the Danish internet treatment program, SpilleFri
  • •IT skills and access to internet and computer/tablet
  • •Willingness to participate in an internet-delivered psychological treatment program for Pathological Gambling

排除标准

  • •Current moderate or severe psychiatric disorder that demands special, individualized treatment, or clinical suspicion hereof, e.g. treatment-demanding depression, personality disorder, psychotic symptoms
  • •Untreated ADHD, ADD, or cognitive deficits that will most likely inhibit the patient from being able to read, understand, and work relatively independently in the SpilleFri internet program.

研究组 & 干预措施

Internet-delivered treatment: "SpilleFri".

Experimental

All participants receive the internet-delivered therapist-assisted 8-modules treatment program "SpilleFri".

干预措施: Internet-delivered treatment: "SpilleFri". (Behavioral)

结局指标

主要结局

Feasibility: Recruitment and retention rate

时间窗: Weekly during the intervention, up to 14 weeks

Data will be gathered throughout the study to assess feasibility, defined herein as the extent to which the intervention can be successfully delivered. Primary feasibility outcome is recruitment and retention rate, collected through clinic records and therapist report in web-based questionnaire.

次要结局

  • Feasibility: Contact with therapist pr. patient(Weekly during the intervention, up to 14 weeks)
  • Feasibility: Patient activity in treatment program (log-in time and duration, yielding total minutes spend in treatment program)(Weekly during the intervention, up to 14 weeks)
  • Treatment expectancy and satisfaction(Immediately after the intervention)
  • Clinician experience of treatment(Immediately after the intervention)
  • Gambling problems past month, change(Baseline and immediately after the intervention)
  • Gambling behavior past week, change(Baseline (pre inclusion in treatment), post inclusion (before first session) and immediately after the intervention)
  • Psychological well-being, change(Baseline and immediately after the intervention)
  • Stress, change(Baseline and immediately after the intervention)
  • Symptoms of anxiety, depression, and psychological distress, change(Baseline and immediately after the intervention)
  • Overall health improvement(Immediately after the intervention)
  • Patient quality of life, change(Baseline and immediately after the intervention)
  • Treatment expectancy and satisfaction(Immediately after inclusion in treatment. Before first treatment session)

研究者

发起方
Anna Westh Stenbro
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anna Westh Stenbro

Researcher

Aarhus University Hospital

研究点 (1)

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