Recruiting

Things You Do

Sponsor:

University of Regina

Code:

NCT07806864

Conditions

Depression

Anxiety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Things You Do Program (Ultra-Brief ICBT)

Things You Do Program (Ultra-Brief ICBT + Personalized Feedback)

Study Details

Brief summary:

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.

Conditions

Depression

Anxiety

Study ID

NCT07806864

Start date

Aug 11, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 ).

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

Interventions

Things You Do Program (Ultra-Brief ICBT)

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.

Things You Do Program (Ultra-Brief ICBT + Personalized Feedback)

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.

Primary outcome measure

  • Things You Do-15 (TYD-15) [ Time Frame: Baseline (intake), week 3 and 5 ]
  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline (intake), weeks 3 and 5 ]
  • Generalized Anxiety Disorder - 7 (GAD-7) [ Time Frame: Baseline (intake), weeks 3 and 5 ]

Central Contacts and Locations

Locations

Online Therapy Unit

Recruiting

Regina, Saskatchewan, Canada, S4S0A2

Contacts

More Information

Sponsor

University of Regina

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Depression
  • Anxiety
  • Personalized Feedback
  • Healthy Actions
  • Randomized Controlled Trial
  • Internet-delivered Cognitive Behavioral Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Regina on 2026-09-08.