RecruitingNot ApplicableNCT07095582

Enhancing Internet-Delivered Cognitive Behaviour Therapy With Additional Content

Enhancing Therapist-Guided Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety With Additional Content

Sponsor

University of Regina

Enrollment

494 participants

Start Date

Jun 18, 2025

Study Type

INTERVENTIONAL

Conditions

Depression Anxiety Loneliness

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding extra content and features to an existing online cognitive behavioural therapy (CBT) program improves outcomes for people with depression and/or anxiety. CBT is a structured form of therapy that helps people identify and change negative thinking patterns; this version is self-directed online and is designed to be accessible without needing an in-person therapist. **You may be eligible if...** - You are 18 years or older - You live in Saskatchewan, Canada - You personally report struggling with depression and/or anxiety - You have access to a computer or other internet-capable device - You are willing to learn strategies to self-manage your mental health - You score above 5 on the UCLA-3 loneliness scale at screening **You may NOT be eligible if...** - You have a current severe medical or psychiatric condition requiring immediate professional treatment (e.g., active mania or psychosis, being at immediate risk of suicide, a medical emergency) - You are unable to read and understand English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALInternet-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.

BEHAVIORALAdditional 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.