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Clinical Trials in Canada / NCT07095582
Recruiting Not applicable

Enhancing Internet-Delivered Cognitive Behaviour Therapy With Additional Content

NCT07095582 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2025-06-18
Last updated
2026-04-29

Condition(s) studied

LonelinessDepressionAnxiety

Investigational drug(s) / intervention(s)

Internet-delivered cognitive behavioral therapyAdditional Loneliness Content

Internet-delivered cognitive behavioral therapy: The Wellbeing Course was developed at Macquarie University, Australia. The Wellbeing Course is a transdiagnostic Internet-delivered cognitive behavioural intervention targeting symptoms of depressive and anxiety disorders. It comprises 5 online lessons targeting: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure; and 5) relapse prevention. Materials are presented in a didactic (i.e., text-based with visual images) and case-enhanced learning format (i.e., educational stories demonstrate the application of skills) and include homework activities. Lessons are released gradually in a standardized order over 8 weeks. Phone calls will only be made if there is a significant clinical issue requiring therapist attention that cannot be addressed over email (e.g., sudden increase in symptoms). Therapists will spend \~15 mins per week/per client.

Additional Loneliness Content: The additional Loneliness Content was developed at the Online Therapy Unit, University of Regina, Canada. Relevant sections of the resource will be included at the end of each lesson within the Wellbeing Course. The Loneliness Content provides psychoeducation and skills for loneliness using a cognitive behavioral framework. Consistent with the Wellbeing Course content, the Loneliness Content will target 1) identification of loneliness; 2) loneliness thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling for loneliness; 4) behaviours (conversation skills); and 5) relapse prevention.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Online Therapy Unit Regina Saskatchewan Recruiting
Online Therapy Unit Regina Saskatchewan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07095582 on ClinicalTrials.gov ↗ ← All trials in Canada