- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07806864
An Ultra-Brief ICBT Intervention: The 'Things You Do' Program
Understanding Engagement and Effectiveness of the 'Things You Do' Program
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Marcie Nugent
- Numero di telefono: 306-337-3331
- Email: marcie.nugent@uregina.ca
Backup dei contatti dello studio
- Nome: Heather Hadjistavropoulos
- Numero di telefono: 306-585-5133
- Email: heather.hadjistavropoulos@uregina.ca
Luoghi di studio
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Saskatchewan
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Regina, Saskatchewan, Canada, S4S0A2
- Reclutamento
- Online Therapy Unit
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Contatto:
- Marcie Nugent
- Numero di telefono: 306-337-3331
- Email: marcie.nugent@uregina.ca
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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 ).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: 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.
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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.
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Sperimentale: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Things You Do-15 (TYD-15)
Lasso di tempo: Baseline (intake), week 3 and 5
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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.
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Baseline (intake), week 3 and 5
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Patient Health Questionnaire-9 (PHQ-9)
Lasso di tempo: Baseline (intake), weeks 3 and 5
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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.
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Baseline (intake), weeks 3 and 5
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Generalized Anxiety Disorder - 7 (GAD-7)
Lasso di tempo: Baseline (intake), weeks 3 and 5
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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.
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Baseline (intake), weeks 3 and 5
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Satisfaction with Life Scale (SWLS)
Lasso di tempo: Baseline (intake), week 3 and 5
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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.
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Baseline (intake), week 3 and 5
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Feedback Questionnaire
Lasso di tempo: Week 3 and 5
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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.
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Week 3 and 5
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Personalized Feedback Report Satisfaction Questionnaire
Lasso di tempo: Week 3 and 5
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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.
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Week 3 and 5
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Heather Hadjistavropoulos, PhD, University of Regina
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
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