Enhancing Internet-Delivered Cognitive Behaviour Therapy With Additional Content
NCT ID: NCT07095582
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
494 participants
INTERVENTIONAL
2025-06-18
2027-06-30
Brief Summary
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Detailed Description
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In Saskatchewan, the Online Therapy Unit (OTU) offers ICBT as part of routine care for a range of mental health concerns. The flagship program is the Wellbeing Course, a transdiagnostic ICBT program targeting symptoms of depression and anxiety. Research shows this course is associated with substantial significant improvements in depression and anxiety that are maintained over time. Nevertheless, not all clients engage with or respond equally to treatment. Consequently, there is a need to explore enhancements to ICBT that may improve outcomes for clients receiving care in naturalistic settings.
Emerging research shows a strong association between depression, anxiety and loneliness. Consistent with these findings, OTU recently found that approximately 76% of past OTU clients who enrolled in the Wellbeing Course reported experiencing frequent loneliness. Notably, ICBT was found to reduce loneliness in addition to alleviating symptoms of depression and anxiety.
Previous studies have found that many OTU clients engage with supplementary resources provided alongside the Wellbeing Course to tailor the program to their individual needs. However, no research to date has examined whether individuals experiencing frequent loneliness derive added benefit from receiving targeted content addressing loneliness in the context of ICBT for depression and anxiety.
The present trial aims to address this gap by evaluating whether offering additional loneliness content alongside the Wellbeing Course leads to greater engagement, satisfaction and improved treatment outcomes among clients with frequent loneliness compared to those who complete the Wellbeing Course alone.
The study is a partially randomized controlled trial conducted within a naturalistic online ICBT clinic. Clients seeking treatment who met the eligibility criteria and reported elevated levels of loneliness (i.e., ≥ 6 on the UCLA loneliness scale) are considered for inclusion in the study. Due to practical constraints related to therapist workload and the volume of referrals, not all eligible clients will be enrolled. To manage this, a subset of eligible clients are randomly assigned to one of two study conditions: (1) the Wellbeing Course or (2) the Wellbeing Course plus a Loneliness Resource. Other eligible clients are assigned to receive the standard Wellbeing Course outside of the study protocol, depending on service capacity at the time of intake. These non-study clients are not included in the study analyses. This approach allowed for the evaluation of the loneliness resource while maintaining routine clinical operations and equitable service access. Therapist support will be offered alongside the Course to all eligible clients for 8 weeks, with the possibility of extended support (when requested and clinically indicated) up to 12 weeks. Moreover, a booster session will be offered 12 weeks after the start of treatment to help clients review their progress and explore techniques that can assist in addressing any difficulties they may encounter in maintaining their well-being. All clients who take part in the Wellbeing Course will be asked to complete primary outcome questionnaires at screening and weeks 4, 8, and 20. Primary outcomes will be loneliness, depression and anxiety.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Wellbeing Course (No Loneliness Content)
All clients eligible for ICBT will be screened for frequent loneliness. Due to practical constraints related to therapist workload and the volume of referrals, a subset of eligible clients scoring ≥ 6 on the UCLA loneliness scale, will be randomly assigned to the Wellbeing Course or the Wellbeing Course plus Loneliness Content. Participants in both conditions will receive the Wellbeing Course which consists of 5 ICBT lessons released gradually over 8 weeks. They will also receive 8 weeks of therapist support, with the option of extending support to 12 weeks.
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.
Wellbeing Course plus Loneliness Content
Due to practical constraints related to therapist workload and the volume of referrals, a subset of eligible clients scoring ≥ 6 on the UCLA loneliness scale, will be randomly assigned to the Wellbeing Course or the Wellbeing Course plus Loneliness Content. In the Loneliness Content condition, in addition to the 5 ICBT lessons from the Wellbeing Course, participants will receive content pertaining to loneliness with each lesson. This content will be presented at the end of each new lesson of the Wellbeing Course, and provide psychoeducation on loneliness and skills for addressing loneliness. Participants in the Loneliness Content condition will also receive 8 weeks of therapist support, with the option of extending support to 12 weeks.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Unable to read and understand English (All content is provided in English and staff is English speaking)
18 Years
ALL
No
Sponsors
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Government of Saskatchewan, Ministry of Health
UNKNOWN
Linkoeping University
OTHER_GOV
Macquarie University, Australia
OTHER
University of Regina
OTHER
Responsible Party
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Principal Investigators
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Heather Hadjistavropoulos, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Regina
Locations
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Online Therapy Unit
Regina, Saskatchewan, Canada
Online Therapy Unit
Regina, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1086
Identifier Type: -
Identifier Source: org_study_id
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