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临床试验/NCT03145792
NCT03145792已完成不适用

Online Coping Skills Counseling for Problem Gambling and Trauma

University of Windsor2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
2
主要终点
Money spent gambling

研究概览

简要总结

This randomized controlled trial examines the efficacy of two behavioral therapies. Seeking Safety, which addresses co-occurring problem gambling (PG) and posttraumatic stress disorder (PTSD), is being compared to Cognitive-Behavioral Therapy for PG, which addresses only PG. Both models are delivered via telehealth.

详细描述

Our key study question is whether an integrated focus on PG and PTSD (Seeking Safety; SS) offers a useful new option for clinical care compared to a purely problem gambling approach (Cognitive-Behavioral Therapy for PG; CBT-PG). This question-the impact of integrated versus non-integrated treatment for co-occurring disorders-is one of the key issues in the field currently and has never been studied in relation to PG and PTSD.

Our aims are:

  1. To conduct an RCT of SS versus CBT-PG in a sample of 84 people with current PG and PTSD (full or subthreshold).
  2. To evaluate outcomes from baseline to end of treatment and 12 month followup on two primary variables (money lost gambling and number of gambling sessions) and several secondary variables.

Our hypotheses are: (a) SS will do no worse than CBT-PG on the primary PG outcomes as both treatments are designed to address addiction; i.e., both will show improvement from baseline to end of treatment and maintenance of gains through the followup. (b) SS will show superior results on trauma symptoms as SS is designed to address those, whereas CBT-PG is not.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 and over
  • Recruited from the province of Manitoba, Canada
  • Meets criteria for PTSD (full or subthreshold) on the Clinician-Administered PTSD Scale (CAPS)
  • Meets gambling disorder criteria per the DSM-5 Diagnostic Interview of Gambling Severity

排除标准

  • Current uncontrolled psychotic or bipolar I disorder
  • Suicidal or homicidal ideation with intent and/or plan
  • Currently engaging in or planning to engage in any manualized, formal, evidence-based PTSD therapy

结局指标

主要结局

Money spent gambling

时间窗: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months

Change from baseline in amount of money spent gambling in the past month

Number of gambling sessions

时间窗: 6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months

Change from baseline in number of days in the past month during which gambling occurred

次要结局

  • PTSD Checklist (PCL) scores(6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months)
  • Trauma Symptom Checklist 40(6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months)
  • Brief Symptom Inventory-18 scores(6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months)
  • Brief Addiction Monitor scores(6-weeks (mid-treatment), 12-weeks (end-of-treatment), and 12-months)

研究者

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

David Ledgerwood

Adjunct Assistant Professor

University of Windsor

研究点 (2)

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