Adding loneliness-focused lessons to the Wellbeing Course online CBT
Official title: Enhancing Therapist-Guided Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety With Additional Content
Run by University of Regina · NCT07095582 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 494 (estimated) |
| Sponsor | University of Regina Academic / other |
| Locations | 2 sites (Regina, Saskatchewan and 1 other locations) |
| Status | Recruiting |
| Started | June 18, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT07095582 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CommunityRx-Dpeer: peer-led support to help dementia caregivers connect with community resources
This program tests a peer navigator model to help dementia caregivers access personalized community resources and ongoing support over 12 months.
-
Monitoring mental health in university students using digital tools
This study is trying to see if using wearable devices and smartphones can help track the mental health of university students by looking at their activity and sleep patterns over six months.
-
Mindful Smartphone Use: A Mindfulness-Based Program for Teens with Sleep and Mood Challenges
This study tests Mindwire, a mindfulness-based program, to see if it helps teens with problematic phone use who also have depression or anxiety.
-
Tele-based wellbeing centres for women's mental health in Bangladesh
A randomized trial tests whether tele-counselling for depression and anxiety in Bangladeshi women is as effective as in-person counselling.
-
HBOT to see if it helps cognition and well‑being in first responders with prior brain injury
This study tests whether 40 hyperbaric oxygen therapy sessions can improve thinking skills and post-concussion symptoms in current or former first responders with a history of brain injury.
-
Focused ultrasound for mood and anxiety disorders
This study tests whether repeated low-intensity focused ultrasound using the ATTN201 device can help people with subsyndromal to moderate depression, anxiety, or OCD.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.