NCT06178328

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Nov 2023Sep 2026

Study Start

First participant enrolled

November 17, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 21, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

2.8 years

First QC Date

November 30, 2023

Last Update Submit

November 14, 2025

Conditions

Keywords

internet-delivered cognitive behaviour therapybrief intervention

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Pre-treatment, 2 weeks (mid-treatment), 4 weeks (post-treatment), and 17 weeks (follow-up)

Secondary Outcomes (3)

  • Days out of role - 1 item

    Pre-treatment, 4 weeks (post-treatment), and 17 weeks (follow-up)

  • Satisfaction with life scale (SWLS)

    Pre-treatment, 4 weeks (post-treatment), and 17 weeks (follow-up)

  • Feedback questions

    4 weeks (post-treatment)

Study Arms (1)

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.

Behavioral: Things You Do Course

Interventions

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.

Brief psychological intervention (Things You Do)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Canadian resident;
  • Aged 18 years or older;
  • Seeking services for mental health concerns

You may not qualify if:

  • Living outside of Canada
  • Unable to read and understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Online Therapy Unit- University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

RECRUITING

Related Publications (4)

  • 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.

    BACKGROUND
  • 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).

    BACKGROUND
  • 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.

    PMID: 36456993BACKGROUND
  • Statistics 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)

    BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Heather Hadjistavropoulos, PhD

    University of Regina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Hadjistavropoulos, PhD

CONTACT

Marcie Nugent, MSW

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 21, 2023

Study Start

November 17, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations