Feasibility, Acceptability, and Potential Efficacy of an Adjunct Digital Health Solution to Standard Dialectical Behavior Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Severity of Dependence Scale
研究概览
简要总结
This study aims to provide access to an adjunct intervention alongside standard group DBT services to examine feasibility, acceptability, and potential added efficacy of the adjunct. The adjunct intervention is an online tool based on DBT skills training and was already evaluated as a self-guided intervention. Participants will complete a baseline session and be given immediate access to the adjunct intervention. Participants will be followed for 12 weeks and complete assessments every 4 weeks.
详细描述
The purpose of this study is to evaluate the potential benefits of an optional add-on tool (i.e., an additional tool participants can use at the same time) alongside standard dialectical behavior therapy (DBT) group treatment (i.e., skills training). The adjunct tool is an online website that participants can use on any device connected to the internet and is also based on DBT.
The proposed study will be a single-arm pragmatic clinical trial aiming to recruit 30 participants over the course of 12 months. Participation in this research study includes a telephone screening visit, informed consent, and baseline assessment visit (conducted via video conferencing). Following the baseline assessment there will be three follow-up assessments completed remotely at weeks 4, 8, and 12.
The adjunct intervention is Pocket Skills 2.0, a skills training app based on dialectical behavior therapy. Participants receive access to this tool in conjunction with their start of standard dialectical behavior therapy. A member of the research team will help participants sign-in for the first time. The tool can be used in any internet browser on any device connected to the internet (e.g., computer, smartphone, tablet). Participants are expected to use the app at least twice a week.
At baseline, a brief interview is completed, along with some questionnaires online. Participants are also asked about the treatment they recently started/plan to start. The interview (40-60 minutes) will involve questions about background, treatment history, and current and past psychological symptoms, and history of substance use. The questionnaires ask a range of questions related to mood, and difficulties with functioning, among other questions. These questions should only take about 15-20 minutes to answer and should be completed within 24 hours.
Participants receive requests to complete additional questionnaires online on three additional occasions (week 4, 8, and 12). Links to the questionnaire package will be sent via email (or text) and they will involve questions about well-being as well as a chance to provide open-ended feedback on the app itself. These surveys will take roughly 15-20 minutes. After 12 weeks, participants are reimbursed for their time.
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
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16 to 70
- •Fluency in English.
- •Understanding and willingness to comply with study requirements / capable of providing autonomous informed consent.
- •Smartphone or tablet capable of downloading and running the web application, or a computer with access to the internet.
- •Past year alcohol or substance use disorder
- •Use of alcohol or substance in the past month.
- •Starting DBT or has started DBT within the last 15 days.
- •Reports at least "contemplation" levels (score of 4+) of change with respect to substance use problems.
排除标准
- •Any known practical factors that would preclude participation (e.g., extended absences) in the study.
- •Acute psychiatric (e.g., psychosis, mania) or medical condition (including acute intoxication or withdrawal requiring medical attention) that precludes participation in this study.
- •Participation in another treatment/intervention study.
结局指标
主要结局
Severity of Dependence Scale
时间窗: 30 days
Level of dependence on most problematic substance over past 30 days. Minimum score: 0, maximum score 15. Higher scores mean worse outcome.
次要结局
- Patient Health Questionnaire-9 (Depression Subscale; PHQ-9)(14 days)
- Generalized Anxiety Disorder-7 (GAD-7) Scale(14 days)
- Difficulties in Emotion Regulation Scale, Short Form (DERS-SF; Kaufmann et al., 2015)(30 days)
- WHO Disability Assessment Schedule Short Form (WHODAS 2.0)(30 days)
- Mindful Attention and Awareness Scale (MAAS)(30 days)
- Suicidal Behaviors Questionnaire, Revised (SBQ-R; Osman et al., 2001)(30 days)
- Risky, Impulsive, and Self-Destructive Questionnaire (RISQ)(30 days)
- NIDA Assist(30 days)
- Daily Drinking Questionnaire (DDQ)(30 days)
- Dialectical Behavioral Therapy Ways of Coping Checklist(30 days)
研究者
Alexander Daros
Assistant Professor
Centre for Addiction and Mental Health