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

NCT07806864 | Recruiting

• 1 other identifier: 2119
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Things You Do-15 (TYD-15)

  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)

  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)

  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

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

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

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.

Behavioral: Things You Do Program Plus Personalized Feedback

Interventions

Things You Do Program (Ultra-Brief ICBT) BEHAVIORAL

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.

ICBT Without Personalized Feedback

Things You Do Program Plus Personalized Feedback BEHAVIORAL

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.

ICBT With Personalized Feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Regina: lead
• Macquarie University, Australia: collaborator

Study Sites (1)

Online Therapy Unit

Regina, Saskatchewan, S4S0A2, Canada

RECRUITING

Related Publications (5)

• Powers JM, Zvolensky MJ, Ditre JW. An integrative review of personalized feedback interventions for pain and alcohol. Curr Opin Psychol. 2019 Dec;30:48-53. doi: 10.1016/j.copsyc.2019.01.013. Epub 2019 Jan 30.

  PMID: 30825840 RESULT

• Yang CM, Lu YL, Lee HC, Li S, Suh S, Okajima I, Huang YC. Can adding personalized rule-based feedback improve the therapeutic effect of self-help digital cognitive behavioral therapy for insomnia in young adults? Sleep Med. 2023 Jul;107:36-45. doi: 10.1016/j.sleep.2023.04.012. Epub 2023 Apr 14.

  PMID: 37105069 RESULT

• Sapkota RP, Gretton A, Wilhelms A, Bisby MA, Dear B, Titov N, Hadjistavropoulos HD. Feasibility trial of an unguided ultra-brief online psychological intervention within an online mental health clinic: The "things you do" intervention. Internet Interv. 2025 Jun 26;41:100852. doi: 10.1016/j.invent.2025.100852. eCollection 2025 Sep.

  PMID: 40641667 RESULT

• Bisby MA, Barrett V, Staples LG, Nielssen O, Dear BF, Titov N. Things You Do: A randomized controlled trial of an unguided ultra-brief intervention to reduce symptoms of depression and anxiety. J Anxiety Disord. 2024 Jul;105:102882. doi: 10.1016/j.janxdis.2024.102882. Epub 2024 May 27.

  PMID: 38850775 RESULT

• Bisby MA, Dear BF, Karin E, Fogliati R, Dudeney J, Ryan K, Fararoui A, Nielssen O, Staples LG, Kayrouz R, Cross S, Titov N. An open trial of the Things You Do Questionnaire: Changes in daily actions during internet-delivered treatment for depressive and anxiety symptoms. J Affect Disord. 2023 May 15;329:483-492. doi: 10.1016/j.jad.2023.02.117. Epub 2023 Mar 1.

  PMID: 36863469 RESULT

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Heather Hadjistavropoulos, PhD

  University of Regina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcie Nugent

CONTACT

306-337-3331; marcie.nugent@uregina.ca

Heather Hadjistavropoulos

CONTACT

306-585-5133; heather.hadjistavropoulos@uregina.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: August 11, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

CA (1)