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临床试验/NCT05127733
NCT05127733招募中不适用

Online Cognitive Behavioural Therapy for Substance Use Disorder: The Impact of Peer Support

Centre for Addiction and Mental Health2 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2021年10月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
225
试验地点
2
主要终点
Timeline Follow-Back

研究概览

简要总结

The purpose of this study is to evaluate the efficacy and cost-effectiveness of Breaking Free Online, in a comparison of outpatients seeking treatment for substance use disorder who receive standard care with group peer support, versus with access to Breaking Free Online, versus with access to Breaking Free Online and individual peer support.

详细描述

A total of 225 outpatients receiving standard care for substance use disorder from the Centre for Addiction and Mental Health will be randomized to receive clinical monitoring (CM) with group peer support, Breaking Free Online only, or Breaking Free Online with individual peer support, in an eight-week trial with a six-month follow-up period. The primary outcome is substance use frequency; secondary outcomes include substance use problems, depression, anxiety, quality of life, treatment engagement, and cost-effectiveness.

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

入选标准

  • 18 years of age and above
  • Fluency in English
  • Understanding and willingness to comply with study requirements & provide informed consent
  • Current substance use disorder
  • Have used alcohol or substances within the past 30 days
  • Registration with CAMH Addictions Program outpatient services

排除标准

  • Current psychosis or mania
  • Current psychiatric disorder requiring care more urgently than substance use, including acute intoxication or withdrawal requiring medical attention
  • Significant neurological disorder or physical illness likely to interfere with participants
  • Any known practical factors that would preclude participation (e.g., extended absences)
  • Inability to read at a sixth grade level

研究组 & 干预措施

Online Cogntivie Behavioural Therapy

Experimental

Breaking Free Online (BFO) is an online intervention, supporting adults struggling with substance use. It provides psychoeducation and skills building exercises in CBT and compatible approaches. The intervention strategies contained within BFO are provided via a six-domain biopsychosocial model used in CBT. Each domain of the model corresponds to a module in the BFO program which contains psychoeducation and an 'action' strategy to facilitate behaviour change. Data captured at the baseline assessment is used by the program to provide feedback to the individual on their levels of functioning across the six domains. The program then guides the user to concentrate on intervention strategies for domains with the greatest level of impairment.

All groups will receive 'clinical monitoring,' including biweekly study assessments during the acute treatment period and monthly assessments during the six month follow-up period.

干预措施: Online Cognitive Behavioural Therapy (Behavioral)

Online Cognitive Behavioural Therapy Plus Individual Peer Support

Experimental

BFO delivered with peer support will comprise BFO with at least weekly contact with a peer with lived experience. Peer support workers will receive training on how to facilitate participant engagement with and progress through the BFO program, as well as a weekly session plan. As part of this training, peer support workers will be given their own access code to use BFO and be encouraged to use the program. Session One constitutes an initial orienting to the program. Subsequent sessions review each information and action strategy in the BFO program, with a series of prompts to guide peer support of this content.

All groups will receive 'clinical monitoring,' including biweekly study assessments during the acute treatment period and monthly assessments during the six month follow-up period.

干预措施: Online Cognitive Behavioural Therapy (Behavioral)

Online Cognitive Behavioural Therapy Plus Individual Peer Support

Experimental

BFO delivered with peer support will comprise BFO with at least weekly contact with a peer with lived experience. Peer support workers will receive training on how to facilitate participant engagement with and progress through the BFO program, as well as a weekly session plan. As part of this training, peer support workers will be given their own access code to use BFO and be encouraged to use the program. Session One constitutes an initial orienting to the program. Subsequent sessions review each information and action strategy in the BFO program, with a series of prompts to guide peer support of this content.

All groups will receive 'clinical monitoring,' including biweekly study assessments during the acute treatment period and monthly assessments during the six month follow-up period.

干预措施: Individual Peer Support (Behavioral)

Group Peer Support

Active Comparator

The control condition will consist of group peer support facilitated by trained peers and offered through the Community Addictions Peer Support Association (CAPSA). The group meets weekly and will offer participants a space to share their experiences and receive support.

All groups will receive 'clinical monitoring,' including biweekly study assessments during the acute treatment period and monthly assessments during the six month follow-up period.

干预措施: Group Peer Support (Behavioral)

结局指标

主要结局

Timeline Follow-Back

时间窗: 30 days

Frequency (days) of substance use over the past 30 days

次要结局

  • Qualitative Interview(10 months)
  • Program and Client Costs- Substance Abuse Treatment (PACC-SAT)(7 days)
  • Treatment Acceptability/Adherence Scale(Baseline, up to 8 weeks, and up to 6 months)
  • Severity of Dependence Scale(1 month)
  • Drug Use Disorders Identification Test(1 month)
  • World Health Organization Quality of Life Assessment(4 weeks)
  • Contemplation Ladder(Baseline, up to 8 weeks, and up to 6 months)
  • World Health Organization Disability Assessment Schedule 2.0(30 days)
  • Alcohol Use Disorder Identification Test(1 month)
  • Generalized Anxiety Disorder-7(14 days)
  • Brief COPE Scale(Baseline, up to 8 weeks, and up to 6 months)
  • Patient Health Questionaire-9(14 Days)
  • Substance Use Calendar (SUC)(14 days)
  • Adult Hope Scale(Baseline, up to 8 weeks, and up to 6 months)
  • Positive and Negative Affect Schedule - Expanded Form(30 days)

研究者

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

Lena Quilty

Senior Scientist

Centre for Addiction and Mental Health

研究点 (2)

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