Recruiting

Things You Do

Sponsor:

University of Regina

Code:

NCT06178328

Conditions

Depression, Anxiety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Things You Do Course

Study Details

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.

Conditions

Depression, Anxiety

Study ID

NCT06178328

Start date

Nov 17, 2023

Status verified date

Nov, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Things You Do Course

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.

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) ]
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: Pre-treatment, 2 weeks (mid-treatment), 4 weeks (post-treatment), and 17 weeks (follow-up) ]
  • Generalized Anxiety Disorder 7-Item (GAD-7) [ Time Frame: Pre-treatment, 2 weeks (mid-treatment), 4 weeks (post-treatment), and 17 weeks (follow-up) ]

Central Contacts and Locations

Central contacts

Heather Hadjistavropoulos, PhD

306-585-5133hadjista@uregina.ca

Locations

Online Therapy Unit- University of Regina

Recruiting

Regina, Saskatchewan, Canada, S4S 0A2

Contacts

Principal Investigator:

Heather Hadjistavropoulos, PhD

More Information

Sponsor

University of Regina

Last update posted

Nov 19, 2025

Last verified

Nov, 2025

Keywords

  • internet-delivered cognitive behaviour therapy
  • brief intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Regina on 2025-11-19.