跳至主要内容
临床试验/NCT07806864
NCT07806864招募中不适用

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

University of Regina1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年8月11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
250
试验地点
1
主要终点
Things You Do-15 (TYD-15)

研究概览

简要总结

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.

详细描述

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

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 (Participant)

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

  • 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.

排除标准

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

研究组 & 干预措施

ICBT Without Personalized Feedback

Active Comparator

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.

干预措施: Things You Do Program (Ultra-Brief ICBT) (Behavioral)

ICBT With Personalized Feedback

Experimental

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.

干预措施: Things You Do Program Plus Personalized Feedback (Behavioral)

结局指标

主要结局

Things You Do-15 (TYD-15)

时间窗: 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.

Patient Health Questionnaire-9 (PHQ-9)

时间窗: 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.

Generalized Anxiety Disorder - 7 (GAD-7)

时间窗: 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.

次要结局

  • Satisfaction with Life Scale (SWLS)(Baseline (intake), week 3 and 5)
  • Feedback Questionnaire(Week 3 and 5)
  • Personalized Feedback Report Satisfaction Questionnaire(Week 3 and 5)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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