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临床试验/NCT07088939
NCT07088939招募中不适用

Feasibility and Acceptability of a Self-guided Internet-delivered Dialectical Behavior Therapy Intervention for Adults With Mental Health Challenges

University of Windsor2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月20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
40
试验地点
2
主要终点
Treatment Acceptability and Adherence Scale

研究概览

简要总结

Dialectical behavior therapy (DBT) is a comprehensive, third-wave psychological intervention designed for patients with complex and severe behavioral, emotional, and interpersonal dysfunction. DBT has since been adapted to shorter, briefer, "skills training" formats, which have been effective for a number of mild-to-moderate mental health conditions, including depression and anxiety. Moreover, internet-delivered formats of DBT (iDBT) have similarly started to build support for their effectiveness, although there are fewer studies on digital formats. One study found that over 12 weeks, iDBT was deemed acceptable (e.g., 50% of participants were still active after 4 weeks) and there were improvements in multiple symptom domains, such as depression, anxiety, suicidality, functional disability, as well as alcohol and substance dependence.

In the current study, the investigators will examine the feasibility, acceptability, and potential efficacy of a new iDBT intervention, packaged as an online e-learning skills course, with adult participants. The study is a pilot trial as iDBT has never been tested in this format through formal research. Thus, this pilot study aims to examine whether this course is usable, practical, and potentially useful to others in the future. The investigators will recruit up to 40 individuals with mild-to-moderate depression and anxiety for an 8-week study. Following a phone screen to determine eligibility, participants will complete a baseline session where they will provide consent, complete a brief interview and questionnaires, and register for the e-learning skills course. Over the course of 8 weeks, participants will be exposed to material adapted from a DBT manual in a self-guided manner. Participants will complete follow-up assessments at 4 and 8 weeks.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18 years old and up.
  • Reside in Ontario.
  • Fluent in English.
  • Able to provide autonomous informed consent
  • Reports at least mild depression and/or anxiety symptoms
  • Not currently receiving any psychotherapy or psychosocial interventions.
  • Have access to the internet

排除标准

  • Practical (e.g., scheduling), acute psychiatric (e.g., suicidal ideation nearly every day, recent hospitalization for mental health reasons), or medical reasons (e.g., upcoming surgery, medical procedure, head injury).
  • Not meeting one or more of the above inclusion criteria

研究组 & 干预措施

Internet-delivered, self-guided dialectical behavior therapy

Experimental

Treatment arm

干预措施: dialectical behavior therapy (Behavioral)

结局指标

主要结局

Treatment Acceptability and Adherence Scale

时间窗: 4 weeks and 8 weeks

The Treatment Acceptability and Adherence Scale was used to assess ratings of perceived effectiveness, trustworthiness, and likelihood of adherence using a 7-point Likert scale from 1 (disagree strongly) to 7 (agree strongly). Items are summed to create a total score, with higher ratings indicating higher acceptability and adherence.

Intervention Usability Scale

时间窗: 4 weeks and 8 weeks

The Intervention Usability Scale is a 10-item measure to assess the ease of accessing and usability of the intervention. Items are rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). A total score is created by summing the items and higher ratings indicate higher usability of the intervention.

次要结局

  • Credibility and Expectancy Questionnaire(Baseline)
  • Patient Health Questionnaire Depression Subscale(Baseline, 4 weeks, and 8 weeks)
  • Generalized Anxiety Disorder 7 Questionnaire(Baseline, 4 weeks, and 8 weeks)
  • World Health Organization Disability Assessment Schedule 2.0 Short Form(Baseline, 4 weeks, and 8 weeks)
  • National Institute on Drug Abuse Assist for Alcohol and Substance Use(Baseline, 4 weeks, and 8 weeks)

研究者

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

Alexander Daros

Assistant Professor

University of Windsor

研究点 (2)

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