NCT07095582 Enhancing Internet-Delivered Cognitive Behaviour Therapy With Additional Content
| NCT ID | NCT07095582 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Regina |
| Condition | Loneliness |
| Study Type | INTERVENTIONAL |
| Enrollment | 494 participants |
| Start Date | 2025-06-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 494 participants in total. It began in 2025-06-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study evaluates the effectiveness of additional content on loneliness offered alongside the Wellbeing Course - an internet-delivered cognitive behavioral therapy (ICBT) intervention for symptoms of depression and anxiety- in improving treatment outcomes for individuals with elevated scores on loneliness seeking treatment for depression and anxiety at a routine care online therapy clinic (the Online Therapy Unit). In this partially randomized control trial, the investigators aim to contribute to the literature by examining whether providing additional content on loneliness alongside the Wellbeing Course enhances engagement, satisfaction, and treatment outcomes among clients experiencing frequent loneliness compared to those completing only the Wellbeing Course. Over 8 weeks, participants will review course materials (with the addition of the loneliness content for those assigned to the loneliness content condition) online and complete questionnaires assessing changes in various outcomes over time.
Eligibility 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)
Contact & Investigator
Heather Hadjistavropoulos, PhD
PRINCIPAL INVESTIGATOR
University of Regina
Frequently Asked Questions
Who can join the NCT07095582 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Loneliness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07095582 currently recruiting?
Yes, NCT07095582 is actively recruiting participants. Contact the research team at marcie.nugent@uregina.ca for enrollment information.
Where is the NCT07095582 trial being conducted?
This trial is being conducted at Regina, Canada, Regina, Canada.
Who is sponsoring the NCT07095582 clinical trial?
NCT07095582 is sponsored by University of Regina. The principal investigator is Heather Hadjistavropoulos, PhD at University of Regina. The trial plans to enroll 494 participants.