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

University of Regina

Status: Enrolling

Conditions: Depression; Anxiety

Treatments: Behavioral: Things You Do Program (Ultra-Brief ICBT); Behavioral: Things You Do Program (Ultra-Brief ICBT + Personalized Feedback)

Study type: Interventional

Funder types: Other

Identifiers

NCT07806864

2119

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 ).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

ICBT Without Personalized Feedback

Active Comparator group

Description:

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.

Treatment:

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

ICBT With Personalized Feedback

Experimental group

Description:

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.

Treatment:

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