Adding loneliness-focused lessons to the Wellbeing Course online CBT
Enhancing Therapist-Guided Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety With Additional Content
We will test whether adding loneliness-focused lessons to an online CBT course helps adults in Saskatchewan with depression or anxiety who often feel lonely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 494 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Regina Academic / other |
| Locations | 2 sites (Regina, Saskatchewan and 1 other locations) |
| Trial ID | NCT07095582 on ClinicalTrials.gov |
What this trial studies
This partially randomized controlled trial compares the standard Wellbeing Course to the Wellbeing Course plus additional loneliness-specific content delivered over eight weeks through the Online Therapy Unit. Participants complete structured online lessons with brief therapist guidance via secure messaging or phone and complete questionnaires (including UCLA-3) to track loneliness, depression, anxiety, engagement, and satisfaction. The aim is to see if the added loneliness content improves engagement, satisfaction, and symptom outcomes for clients reporting frequent loneliness. The trial is conducted within routine clinical care to evaluate real-world applicability.
Who should consider this trial
Good fit: Adults 18 and older living in Saskatchewan who report difficulty with depression and/or anxiety, have an elevated UCLA-3 loneliness score (>5), can read English, and have internet access are the ideal candidates.
Not a fit: People with active severe psychiatric or medical crises (for example current mania, psychosis, or active suicidal intent), those unable to read English, under 18, or living outside Saskatchewan are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the added content could increase engagement and reduce loneliness while improving depression and anxiety outcomes for people using online CBT.
How similar studies have performed: Existing evidence shows the Wellbeing Course improves depression and anxiety and can reduce loneliness, but specifically adding dedicated loneliness-targeted content is a newer enhancement with limited prior testing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Saskatchewan resident, * Aged 18 years or older, * Self-reported difficulty with depression and/or anxiety, * Access to a computer (or other appropriate device) and the Internet, * Willingness to learn information and skills to self-manage mental health difficulties, and * Total score on UCLA-3 is greater than 5 at screening Exclusion Criteria: * Current severe medical or psychiatric condition that requires immediate treatment (e.g. current mania or psychosis, actively suicidal or unable to keep themselves safe, medical condition requiring immediate surgery or other invasive treatment); * Unable to read and understand English (All content is provided in English and staff is English speaking)
Where this trial is running
Regina, Saskatchewan and 1 other locations
- Online Therapy Unit — Regina, Saskatchewan, Canada (Recruiting)
- Online Therapy Unit — Regina, Saskatchewan, Canada (Recruiting)
Study contacts
- Principal investigator: Heather Hadjistavropoulos, PhD — University of Regina
- Study coordinator: Marcie Nugent, MSW
- Email: marcie.nugent@uregina.ca
- Phone: 306-337-3331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.