Depression, AnxietyNCT06178328
Observations of a Brief Online Psychological Intervention Among People Seeking Online Mental Health Services
An observational study of Depression, Anxiety, run by University of Regina at 1 site in Canada.
Trial summary
Since 2012, the Online Therapy Unit has been offering Internet-delivered cognitive behaviour therapy (ICBT). ICBT represents a convenient method for individuals to access care for depression and anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Things You Do Course
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 262 participants
- Where
- 1 siteCanada
- Study dates
- 17 Nov 2023to 11 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This observational pilot trial explores aspects of the TYD course within an online routine care setting, a first-of-its-kind in Canada. Prospective participants will self-refer after learning about the course from advertisements, information on the Online Therapy Unit website, or from healthcare providers, community organizations, or others.
Who may be able to join
- Canadian resident;
- Aged 18 years or older;
- Seeking services for mental health concerns
Who cannot join
- Living outside of Canada
- Unable to read and understand English
Trial locations and contacts
1 site in 1 country.
Canada1 site
Online Therapy Unit- University of Regina
Regina, Saskatchewan, S4S 0A2
About this study
Official title: 'Things You Do': An Observational Pilot Trial of a Brief Psychological Intervention Among People Seeking Online Mental Health Services
Since 2012, the Online Therapy Unit has been offering Internet-delivered cognitive behaviour therapy (ICBT). ICBT represents a convenient method for individuals to access care for depression and anxiety. In ICBT, clients receive access to standardized lessons that provide the same information and skills as traditional face-to-face CBT. ICBT courses often span 6-12 weeks. There is now growing evidence that clients with symptoms of depression and anxiety can benefit from a single session brief intervention that offers practical strategies for improving mental health, but the investigators are uncertain about the interest in such a lesson among those seeking online mental health care. The Things You Do Course, therefore, is designed to provide clients with 5 key actions that clients can take to improve their emotional wellbeing.
In this study, the Online Therapy Unit (OTU) is examining how effective the Things You Do Course is in helping clients manage their symptoms of depression and anxiety and improve their emotional wellbeing. The OTU is also exploring the extent to which clients are satisfied with the course, and what factors contribute to improvements in symptoms, as measured by a number of questionnaires. The research will ultimately be used to improve how the OTU will deliver ICBT and to inform whether to include the single session course within existing online mental health service options.
Read the detailed description
A scarcity of mental health care practitioners across Canada has resulted in extensive wait times. This issue is compounded by the significant cost associated with accessing psychological services, lack of awareness about service availability, and the constraints of time that hinder using long-term (multi-session) psychological therapies. These challenges are frequently cited as barriers to the access and utilization of psychological services in Canada. Unfortunately, this situation leaves many Canadians grappling with physical and mental disabilities, economic productivity losses, and facing an elevated risk of suicide due to unmet mental health care needs. Thus, there is a need for efficient and sustainable service delivery models that enable quick access to treatment for mental health concerns.
There is substantial evidence for the use of internet-delivered cognitive behaviour therapy (ICBT) as an alternative to face-to-face cognitive behaviour therapy (CBT) for the treatment of common mental health concerns such as anxiety and depression. The duration of ICBT courses varies, but most involve several lessons spanning 6-12 weeks. Offering brief, low-intensity supports may help alleviate barriers related to treatment seekers' time constraints.In face-to-face services, there is growing evidence that clients with symptoms of depression and anxiety can benefit from a single session intervention, but there is limited research on the use of single session interventions in ICBT, particularly within Canada.
Preliminary findings from the eCentre Clinic in Australia on a single lesson intervention (i.e., the 'Things You Do' course; TYD) are promising. The TYD is a single online lesson that provides psychoeducation about factors that contribute to mental health, as well as 5 target areas that clients can focus on to improve their mental health: realistic thinking, meaningful activities, goal setting, healthy routines, and social connections. Clients who completed the TYD reported significant improvements in depression and anxiety from pre- to post-treatment, with changes maintained at 12-week follow-up.
Given these promising preliminary findings, investigators propose to implement and evaluate the acceptability and short-term effects of a single-session intervention, the 'Things You Do' (TYD), in a Canadian context. The TYD is focused on everyday behaviours and actions that most people can choose to do, that is, it comprises modifiable behaviours which most people would recognize as important for mental health. It therefore has the potential to serve as a scalable, self-guided mental health intervention.
The following research questions will be evaluated:
- What will be the uptake of the TYD course relative to other online mental health courses in the Online Therapy Unit?
- What are the baseline demographic and clinical (e.g., severity levels of anxiety and depression symptoms) characteristics of individuals who sign up for the TYD?
- How acceptable is the TYD in a Canadian context, as assessed via participants' ratings and feedback on likes and dislikes about the course content and process?
- Will participating in TYD result in a clinically significant reduction in symptoms related to anxiety and depression and improvements in other measures administered?
- What baseline demographic and clinical characteristics are related to outcomes post-treatment?
- What percentage of TYD participants express interest in seeking out and enrolling in other online services offered by the Online Therapy Unit and how many individuals from other online services offered by the Online Therapy Unit subsequently enroll in TYD?
The study will begin with a pilot trial to examine research question 4. The intention is to collect more information if feasible to answer the other research questions related to uptake of the course, exploration of demographic and clinical characteristics of those who take the course, acceptability of the course and feedback on the course, relationship of demographic and clinical characteristics to outcomes and subsequent use of other services after taking the TYD course.
- Conditions
- Depression, Anxiety
- Being tested
- Things You Do Course
- Keywords
- internet-delivered cognitive behaviour therapy, brief intervention
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Things You Do CourseBehavioural
Participants receiving the brief psychological intervention ('Things You Do' Course) will have access to a single online lesson that includes course materials and printable materials (i.e., an activity guide and planner) that can be retained for longer-term use. The course materials include an introduction to the purpose and content of the course, education about factors that impact mental health, and information about the 'Big Five' things participants can do to improve their mental health. Participants will also receive automated no-reply emails (5 days/week) through the intervention platform to remind them to practice the skills from the course.
| Study group | Role | What they receive |
|---|---|---|
| Brief psychological intervention (Things You Do) | All participants will have access to the online course materials for a period of 4 weeks from the time of enrolment. The materials are self-directed and can be accessed at any time during the 4-week period. Receives: Behavioral: Things You Do Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Things You Do Questionnaire - 21 item (TYD-Q)
A 21-item questionnaire that includes five scales (Realistic Thinking, Meaningful Activities, Goals and Plans, Healthy Habits, and Social Connections) to measure everyday behaviours that are linked to emotional wellbeing. Scores range from 0 to 84.
Measured: Pre-treatment, 2 weeks (mid-treatment), 4 weeks (post-treatment), and 17 weeks (follow-up)
Patient Health Questionnaire (PHQ-9)
9-item measure of depression symptoms. Higher total scores indicate greater severity of depression. Scores range from 0 to 27.
Measured: Pre-treatment, 2 weeks (mid-treatment), 4 weeks (post-treatment), and 17 weeks (follow-up)
Generalized Anxiety Disorder 7-Item (GAD-7)
7-item measure of anxiety symptoms. Higher total scores indicate greater severity of anxiety. Scores range from 0 to 21.
Measured: Pre-treatment, 2 weeks (mid-treatment), 4 weeks (post-treatment), and 17 weeks (follow-up)
Secondary outcomes (3)
Days out of role - 1 item
The functional impairment item from the longer Kessler Psychological Distress - 10 item Plus (K10+) scale to measure disability. Respondents are asked how many days they have been unable to work at all in the previous 4 weeks. Scores range from 0 to 28
Measured: Pre-treatment, 4 weeks (post-treatment), and 17 weeks (follow-up)
Satisfaction with life scale (SWLS)
5-item measure of life satisfaction. Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 7 strongly agree to 1 strongly disagree. Scores range from 5 to 35
Measured: Pre-treatment, 4 weeks (post-treatment), and 17 weeks (follow-up)
Feedback questions
Closed-ended questions about treatment satisfaction; open-ended questions regarding suggestions of how to improve the intervention
Measured: 4 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start17 Nov 2023
- Primary completion29 Jul 2026
- Study completion11 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Hadjistavropoulos, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178328
- Sponsor's protocol ID
- 414
- Status last verified
- Nov 2026
- First submitted
- 30 Nov 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Faber, S. C., Williams, M. T., Metzger, I. W., MacIntyre, M. M., Strauss, D., Duniya, C. G., ... & Goghari, V. M. (2023). Lions at the gate: How weaponization of policy prevents people of colour from becoming professional psychologists in Canada. Canadian Psychology.
Hahmann, T.; Kumar, M.B. Unmet Health Care Needs during the Pandemic and Resulting Impacts among First Nations People Living Off Reserve, Métis and Inuit; Statistics Canada: Ottawa, ON, Canada, 2022; Available online: https://www150.statcan.gc.ca/n1/pub/45-28-0001/2022001/article/00008-eng.htm# (accessed on 3 January 2023).
Khattar J, Griffith LE, Jones A, De Rubeis V, de Groh M, Jiang Y, Basta NE, Kirkland S, Wolfson C, Raina P, Anderson LN; Canadian Longitudinal Study on Aging (CLSA) Team. Symptoms of depression and anxiety, and unmet healthcare needs in adults during the COVID-19 pandemic: a cross-sectional study from the Canadian Longitudinal Study on Aging. BMC Public Health. 2022 Dec 1;22(1):2242. doi: 10.1186/s12889-022-14633-4.
PubMed 36456993Statistics Canada. Health Fact Sheets: Mental Health Care Needs, 2018; Catalogue No. 82-625-X; Statistics Canada: Ottawa, ON, Canada, 2019; Available online: https://www150.statcan.gc.ca/n1/en/pub/82-625-x/2019001/article/00011-eng.pdf (accessed on 10 August 2022)
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Things You Do': An Observational Pilot Trial of a Brief Psychological Intervention Among People Seeking Online Mental Health Services
- ClinicalTrials.gov ID
- NCT06178328
- Acronym / sponsor ID
- 414
- Conditions
- Depression, Anxiety
- Keywords
- internet-delivered cognitive behaviour therapy, brief intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 29 Jul 2026 (actual)
- Study completion
- 11 Aug 2026 (actual)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Since 2012, the Online Therapy Unit has been offering Internet-delivered cognitive behaviour therapy (ICBT). ICBT represents a convenient method for individuals to access care for depression and anxiety. In ICBT, clients receive access to standardized lessons that provide the same information and skills as traditional face-to-face CBT. ICBT courses often span 6-12 weeks. There is now growing evidence that clients with symptoms of depression and anxiety can benefit from a single session brief intervention that offers practical strategies for improving mental health, but the investigators are uncertain about the interest in such a lesson among those seeking online mental health care. The Things You Do Course, therefore, is designed to provide clients with 5 key actions that clients can take to improve their emotional wellbeing.
In this study, the Online Therapy Unit (OTU) is examining how effective the Things You Do Course is in helping clients manage their symptoms of depression and anxiety and improve their emotional wellbeing. The OTU is also exploring the extent to which clients are satisfied with the course, and what factors contribute to improvements in symptoms, as measured by a number of questionnaires. The research will ultimately be used to improve how the OTU will deliver ICBT and to inform whether to include the single session course within existing online mental health service options.
Detailed description
A scarcity of mental health care practitioners across Canada has resulted in extensive wait times. This issue is compounded by the significant cost associated with accessing psychological services, lack of awareness about service availability, and the constraints of time that hinder using long-term (multi-session) psychological therapies. These challenges are frequently cited as barriers to the access and utilization of psychological services in Canada. Unfortunately, this situation leaves many Canadians grappling with physical and mental disabilities, economic productivity losses, and facing an elevated risk of suicide due to unmet mental health care needs. Thus, there is a need for efficient and sustainable service delivery models that enable quick access to treatment for mental health concerns.
There is substantial evidence for the use of internet-delivered cognitive behaviour therapy (ICBT) as an alternative to face-to-face cognitive behaviour therapy (CBT) for the treatment of common mental health concerns such as anxiety and depression. The duration of ICBT courses varies, but most involve several lessons spanning 6-12 weeks. Offering brief, low-intensity supports may help alleviate barriers related to treatment seekers' time constraints.In face-to-face services, there is growing evidence that clients with symptoms of depression and anxiety can benefit from a single session intervention, but there is limited research on the use of single session interventions in ICBT, particularly within Canada.
Preliminary findings from the eCentre Clinic in Australia on a single lesson intervention (i.e., the 'Things You Do' course; TYD) are promising. The TYD is a single online lesson that provides psychoeducation about factors that contribute to mental health, as well as 5 target areas that clients can focus on to improve their mental health: realistic thinking, meaningful activities, goal setting, healthy routines, and social connections. Clients who completed the TYD reported significant improvements in depression and anxiety from pre- to post-treatment, with changes maintained at 12-week follow-up.
Given these promising preliminary findings, investigators propose to implement and evaluate the acceptability and short-term effects of a single-session intervention, the 'Things You Do' (TYD), in a Canadian context. The TYD is focused on everyday behaviours and actions that most people can choose to do, that is, it comprises modifiable behaviours which most people would recognize as important for mental health. It therefore has the potential to serve as a scalable, self-guided mental health intervention.
The following research questions will be evaluated:
- What will be the uptake of the TYD course relative to other online mental health courses in the Online Therapy Unit?
- What are the baseline demographic and clinical (e.g., severity levels of anxiety and depression symptoms) characteristics of individuals who sign up for the TYD?
- How acceptable is the TYD in a Canadian context, as assessed via participants' ratings and feedback on likes and dislikes about the course content and process?
- Will participating in TYD result in a clinically significant reduction in symptoms related to anxiety and depression and improvements in other measures administered?
- What baseline demographic and clinical characteristics are related to outcomes post-treatment?
- What percentage of TYD participants express interest in seeking out and enrolling in other online services offered by the Online Therapy Unit and how many individuals from other online services offered by the Online Therapy Unit subsequently enroll in TYD?
The study will begin with a pilot trial to examine research question 4. The intention is to collect more information if feasible to answer the other research questions related to uptake of the course, exploration of demographic and clinical characteristics of those who take the course, acceptability of the course and feedback on the course, relationship of demographic and clinical characteristics to outcomes and subsequent use of other services after taking the TYD course.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief psychological intervention (Things You Do) | – | Behavioral: Things You Do CourseAll participants will have access to the online course materials for a period of 4 weeks from the time of enrolment. The materials are self-directed and can be accessed at any time during the 4-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This observational pilot trial explores aspects of the TYD course within an online routine care setting, a first-of-its-kind in Canada. Prospective participants will self-refer after learning about the course from advertisements, information on the Online Therapy Unit website, or from healthcare providers, community organizations, or others.
Key inclusion criteria (3 listed)
- Canadian resident;
- Aged 18 years or older;
- Seeking services for mental health concerns
Key exclusion criteria (2 listed)
- Living outside of Canada
- Unable to read and understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Things You Do CourseParticipants receiving the brief psychological intervention ('Things You Do' Course) will have access to a single online lesson that includes course materials and printable materials (i.e., an activity guide and planner) that can be retained for longer-term use. The course materials include an introduction to the purpose and content of the course, education about factors that impact mental health, and information about the 'Big Five' things participants can do to improve their mental health. Participants will also receive automated no-reply emails (5 days/week) through the intervention platform to remind them to practice the skills from the course. | Behavioural | Brief psychological intervention (Things You Do) |
Primary outcome
The Things You Do Questionnaire - 21 item (TYD-Q)
Time frame: Pre-treatment, 2 weeks (mid-treatment), 4 weeks (post-treatment), and 17 weeks (follow-up)
A 21-item questionnaire that includes five scales (Realistic Thinking, Meaningful Activities, Goals and Plans, Healthy Habits, and Social Connections) to measure everyday behaviours that are linked to emotional wellbeing. Scores range from 0 to 84.
Patient Health Questionnaire (PHQ-9)
Time frame: Pre-treatment, 2 weeks (mid-treatment), 4 weeks (post-treatment), and 17 weeks (follow-up)
9-item measure of depression symptoms. Higher total scores indicate greater severity of depression. Scores range from 0 to 27.
Generalized Anxiety Disorder 7-Item (GAD-7)
Time frame: Pre-treatment, 2 weeks (mid-treatment), 4 weeks (post-treatment), and 17 weeks (follow-up)
7-item measure of anxiety symptoms. Higher total scores indicate greater severity of anxiety. Scores range from 0 to 21.
3 secondary outcomes
Days out of role - 1 item
Time frame: Pre-treatment, 4 weeks (post-treatment), and 17 weeks (follow-up)
Satisfaction with life scale (SWLS)
Time frame: Pre-treatment, 4 weeks (post-treatment), and 17 weeks (follow-up)
Feedback questions
Time frame: 4 weeks (post-treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- BackgroundFaber, S. C., Williams, M. T., Metzger, I. W., MacIntyre, M. M., Strauss, D., Duniya, C. G., ... & Goghari, V. M. (2023). Lions at the gate: How weaponization of policy prevents people of colour from becoming professional psychologists in Canada. Canadian Psychology.
- BackgroundHahmann, T.; Kumar, M.B. Unmet Health Care Needs during the Pandemic and Resulting Impacts among First Nations People Living Off Reserve, Métis and Inuit; Statistics Canada: Ottawa, ON, Canada, 2022; Available online: https://www150.statcan.gc.ca/n1/pub/45-28-0001/2022001/article/00008-eng.htm# (accessed on 3 January 2023).
- Background: PubMed 36456993Khattar J, Griffith LE, Jones A, De Rubeis V, de Groh M, Jiang Y, Basta NE, Kirkland S, Wolfson C, Raina P, Anderson LN; Canadian Longitudinal Study on Aging (CLSA) Team. Symptoms of depression and anxiety, and unmet healthcare needs in adults during the COVID-19 pandemic: a cross-sectional study from the Canadian Longitudinal Study on Aging. BMC Public Health. 2022 Dec 1;22(1):2242. doi: 10.1186/s12889-022-14633-4.
- BackgroundStatistics Canada. Health Fact Sheets: Mental Health Care Needs, 2018; Catalogue No. 82-625-X; Statistics Canada: Ottawa, ON, Canada, 2019; Available online: https://www150.statcan.gc.ca/n1/en/pub/82-625-x/2019001/article/00011-eng.pdf (accessed on 10 August 2022)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Hadjistavropoulos, PhD principal investigator
University of Regina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Anxiety, run by University of Regina at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Things You Do Questionnaire - 21 item (TYD-Q) (time frame: Pre-treatment, 2 weeks (mid-treatment), 4 weeks (post-treatment), and 17 weeks (follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06178328, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.