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An Ultra-Brief ICBT Intervention: The 'Things You Do' Program

2026年9月10日 更新者:University of Regina

Understanding Engagement and Effectiveness of the 'Things You Do' Program

Research shows that the single lesson 'Things You Do' Intervention is effective in increasing engagement in everyday healthy actions. However, no research has examined whether its effectiveness is enhanced by incorporating personalized feedback on participants' current level of engagement in healthy actions. In this randomized controlled trial, clients will be randomly assigned to either receive or not receive personalized feedback informing them of their level of engagement in healthy actions over the previous week and encouraging them to participate in more healthy activities. The investigators will examine whether this feedback increases engagement in healthy actions and enhances the effectiveness of the 'Things You Do' Intervention as assessed through changes in primary outcomes.

研究概览

详细说明

Individuals seeking psychological services for mental health concerns often face barriers to care, including long wait times, cost, stigma, time constraints, geographical limitations, and difficulty accessing culturally sensitive providers. To address these barriers, Internet-delivered Cognitive Behavioral Therapy (ICBT) has emerged as a scalable, cost-effective, and accessible alternative to face-to-face therapy for individuals experiencing depression and anxiety. ICBT typically involves the delivery of evidence-based cognitive behavioral therapy through online lesson modules over several weeks or months, often accompanied by therapist support through secure messaging and/or telephone calls. However, research suggests that clients are satisfied with and benefit from brief forms of ICBT that require little to no therapist involvement.

In Saskatchewan, the Online Therapy Unit provides ICBT as part of routine care for a range of mental health concerns. Recently, the Unit introduced the Things You Do (TYD) program, a brief ICBT intervention for depression and anxiety that serves as an alternative to the standard 8-week ICBT program. The TYD program consists of a single lesson designed to reduce symptoms of depression and anxiety and further encourages engagement in everyday healthy actions via daily messaging, referred to as the 'Things You Do'. These healthy actions are organized into five domains: healthy thinking, meaningful activities, goals and plans, healthy routines, and social connections. Research indicates that greater engagement in these healthy actions is associated with lower levels of depression and anxiety, as well as improved overall mental health and well-being. The feasibility, acceptability, and effectiveness of the TYD program in routine care have also yielded promising results in a previous study conducted within the OTU. For instance, the results from this study indicated a significant increase in each of the healthy actions over time. While increased engagement in healthy actions was associated with reductions in anxiety and depressive symptoms, there are still opportunities to improve outcomes by assessing the effects of further personalizing the intervention on the outcomes. Although the TYD program provides information and strategies to encourage engagement in healthy actions, providing participants with personalized feedback regarding their current level of engagement may further enhance behavior change.

Research has demonstrated that personalized feedback can increase individuals' awareness of their own behaviours, facilitate behaviour change in targeted areas, and contribute to improved outcomes. In addition, personalized feedback has been associated with greater treatment satisfaction. Although personalized feedback has demonstrated benefits in areas such as alcohol misuse and pain management, its potential to promote engagement in healthy actions associated with mental health and well-being has not yet been examined. Providing clients with personalized feedback may increase awareness of their areas of strength, identify opportunities for improvement, and offer suggestions for increasing engagement in healthy behaviours.

The objective of the current study is to examine whether providing personalized feedback based on participants' reported frequency of engaging in healthy actions would encourage greater participation in healthy actions and enhance engagement in the TYD program. Participants will complete outcome measures at screening, Week 3, and Week 5. Primary outcomes include symptoms of depression, symptoms of anxiety, and engagement in healthy actions.

Randomization

Clients within a naturalistic online ICBT clinic eligible for the TYD program will be randomly assigned in a 1:1 ratio, using the REDCap randomization module, to either receive the standard TYD program or the standard program plus personalized feedback. The personalized feedback reports, developed using participants' responses to the Things You Do Questionnaire (TYDQ-15), are intended to increase awareness of areas of strength, identify areas for improvement, and provide suggestions for increasing engagement in healthy actions. Clients assigned to the personalized feedback condition will receive feedback at screening, in Week 3, and in Week 5 following completion of the TYDQ-15 at each assessment point.

研究类型

介入性

注册 (估计的)

250

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Saskatchewan
      • Regina、Saskatchewan、加拿大、S4S0A2

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Canadian resident;
  • Aged 18 years or older;
  • Access to a computer (or another appropriate device) and the Internet;
  • Willingness to learn information and skills to self-manage mental health difficulties.

Exclusion Criteria:

  • Unable to read and understand English (All content is provided in English ).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:ICBT Without Personalized Feedback
At intake, clients eligible for the Things You Do (TYD) program will be randomly assigned (1:1 ratio) to either the Feedback Group or the No Feedback Group following completion of the demographic questionnaire, which includes the 15-item Things You Do Questionnaire. Clients will be automatically randomized using the Research Electronic Data Capture (REDCap) automated randomization module. Clients randomized to the No Feedback Group will receive the standard TYD intervention. All clients will complete the standardized questionnaires again in Weeks 3 and 5 following enrollments in the program.
The TYD program is an ultra-brief ICBT intervention developed at Macquarie University, Australia. The intervention provides psychoeducation on mental health and five areas of healthy actions, known as the "Things You Do," along with practical skills to support engagement in these actions. These five areas include Meaningful Activities, Healthy Thinking, Goals and Plans, Healthy Habits, and Social Connections. The intervention includes a single lesson, a Weekly Planner, an Activity Guide, and a daily 'Tip of the Day' Offered for 30 days. The lesson content is presented across 25 slides using text and infographics and requires approximately 30-60 minutes to review. A key component of the TYD intervention is the daily 'Tip of the Day.' These are daily messages that clients receive for 30 days following the start of the intervention. Each message provides a tip or suggests a healthy action that clients can engage in that day. Clients complete the program without therapist support.
实验性的:ICBT With Personalized Feedback
Clients randomly assigned to the Feedback Group will receive the standard Things You Do (TYD) program as well as a personalized feedback report at intake, in Week 3, and in Week 5 following the completion of questionnaires at each of these time points. These personalized feedback reports are generated based on clients' scores on the Things You Do Questionnaire at each assessment time point. The reports are designed to inform clients of their level of engagement in healthy actions across the five areas of healthy actions. The reports highlight areas of strength and areas for improvement and provide encouragement and practical suggestions for increasing engagement in the areas in which clients reported the lowest levels of engagement.
Participants in this arm receive the same Things You Do (TYD) intervention as those in the comparative arm, with the addition of personalized feedback report. The TYD program is an ultra-brief ICBT intervention providing psychoeducation on mental health and five areas of healthy actions: Meaningful Activities, Healthy Thinking, Goals and Plans, Healthy Habits, and Social Connections. The intervention includes a single lesson (25 slides), Weekly Planner, Activity Guide, and daily "Tip of the Day" delivered for 30 days following enrollment in the intervention. Participants complete the intervention independently without therapist support. In addition to the standard TYD intervention, participants in this arm receive a personalized feedback report at screening, in Week 3, and in Week 5 following enrollment. Reports provide individualized feedback on participants' engagement across the five areas of healthy actions and are intended to encourage and motivate engagement in these areas.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Things You Do-15 (TYD-15)
大体时间:Baseline (intake), week 3 and 5
A measure of engagement in healthy actions over the previous week. 15 items are measured on a 5-point Likert scale ranging from 0-4. Subscales include Routine, Thoughts, Social, Activity, and Goals. Scores are summed into subscale scores ranging from 0 to 12, with a total score ranging from 0 to 60. Higher scores on this measure indicate greater engagement in healthy actions.
Baseline (intake), week 3 and 5
Patient Health Questionnaire-9 (PHQ-9)
大体时间:Baseline (intake), weeks 3 and 5
Track the change in depression symptoms over a two-week period. 9 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed with total scores ranging from 0 to 27. Higher scores indicate greater severity in depression symptoms.
Baseline (intake), weeks 3 and 5
Generalized Anxiety Disorder - 7 (GAD-7)
大体时间:Baseline (intake), weeks 3 and 5
Track the change in anxiety symptoms over a two-week period. 7 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed into a total score ranging from 0 to 21. Higher scores indicate greater severity in self-reported anxiety symptoms.
Baseline (intake), weeks 3 and 5

次要结果测量

结果测量
措施说明
大体时间
Satisfaction with Life Scale (SWLS)
大体时间:Baseline (intake), week 3 and 5
A measure of satisfaction with one's life. 5 items are measured on a 7-point scale ranging from 1-7. Scores are summed to produce a total ranging from 5 to 35 with higher scores indicating greater satisfaction with one's life.
Baseline (intake), week 3 and 5
Feedback Questionnaire
大体时间:Week 3 and 5
A bespoke questionnaire consisting of 10 items with varying response formats measuring perceived treatment change and gathering feedback on likes and dislikes with the course. Items are not designed to be combined into a unitary measure. The questionnaire has been developed by the research team. A total score is not produced for this measure.
Week 3 and 5
Personalized Feedback Report Satisfaction Questionnaire
大体时间:Week 3 and 5
A bespoke 4-item questionnaire presented to clients randomized to the Feedback Group. The questionnaire uses a combination of various formats to assess clients' perception of the personalized feedback reports they received and their effectiveness. The questionnaire has been developed by the research team. A total score is not produced for this measure.
Week 3 and 5

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Heather Hadjistavropoulos, PhD、University of Regina

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月11日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年9月1日

首先提交符合 QC 标准的

2026年9月1日

首次发布 (实际的)

2026年9月8日

研究记录更新

最后更新发布 (实际的)

2026年9月15日

上次提交的符合 QC 标准的更新

2026年9月10日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

Participants' de-identified research data will be stored in Borealis. Borealis is the University of Regina's official data repository. Data stored in this repository will be shared with authorized researchers and the research community, upon request, to advance science and health.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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