Online Cognitive Behavioural Therapy for Substance Use Disorder: The Impact of Peer Support
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
- 否
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
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
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
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
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
Lena Quilty
Senior Scientist
Centre for Addiction and Mental Health
