LonelinessNCT07095582
Enhancing Internet-Delivered Cognitive Behaviour Therapy With Additional Content
A study testing Internet-delivered cognitive behavioral therapy and Additional Loneliness Content in people with Loneliness and Depression, run by University of Regina at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Loneliness, Depression, Anxiety
- What is being tested?
- Internet-delivered cognitive behavioral therapy and Additional Loneliness Content
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 2 sitesCanada
- Study dates
- 18 Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Online Therapy Unit
Regina, Saskatchewan, S4S 0A2
Marcie Nugent, MSW, 306-337-3331, marcie.nugent@uregina.ca
Heather Hadjistavropoulos, PhD, 306-585-5133, heather.hadjistavropoulos@uregina.ca
- Recruiting
Online Therapy Unit
Regina, Saskatchewan, S4S0A2
Marcie Nugent, MSW, 306-337-3331, marcie.nugent@uregina.ca
Heather Hadjistavropoulos, PhD, 306-585-5133, heather.hadjistavropoulos@uregina.ca
About this study
Official title: Enhancing Therapist-Guided Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety With Additional Content
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.
Read the detailed description
Depression and anxiety are prevalent mental health conditions that are frequently under-treated. To improve timely and effective psychological treatment, Internet-delivered Cognitive Behaviour Therapy (ICBT) has been developed as a scalable treatment option. ICBT delivers evidence-based therapeutic content via structured online lessons over the course of several months, teaching the same skills as face-to-face cognitive behaviour therapy. In routine practice, ICBT is typically accompanied by brief therapist guidance offered via secure messaging and/or phone calls.
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
- Loneliness, Depression, Anxiety
- Being tested
- Internet-delivered cognitive behavioral therapy, Additional Loneliness Content
- Keywords
- Loneliness, Depression, Anxiety, Internet-delivered cognitive behavioral therapy, Randomized controlled trial, Personalized therapy, Therapist assistance, Mental health system
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered cognitive behavioral therapyBehavioural
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 ContentBehavioural
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 group | Role | What they receive |
|---|---|---|
| Wellbeing Course (No Loneliness Content) | Active comparator | 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. Receives: Behavioral: Internet-delivered cognitive behavioral therapy |
| Wellbeing Course plus Loneliness Content | Experimental | 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. Receives: Behavioral: Internet-delivered cognitive behavioral therapy; Behavioral: Additional Loneliness Content |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA Loneliness Scale 3-item (UCLA-3)
Measures loneliness. 3 items are measured on a 3-point Likert scale ranging from 1-3. Scores are summed into a total score ranging from 3 to 9, with higher scores indicating higher levels of perceived loneliness.
Measured: Baseline (Screening), weeks 4, 8 and 20 from enrollment
Patient Health Questionnaire - 9 (PHQ-9)
Tracking the change in depression symptoms. 9 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed with total scores ranging from 0 to 27. Higher scores are associated with higher depression severity.
Measured: Baseline (Screening), weeks 1-8 and 20 from enrollment
Generalized Anxiety Disorder - 7 (GAD-7)
Tracking the change in anxiety symptoms. 7 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.
Measured: Baseline (Screening), weeks 1-8 and 20 from enrollment
Secondary outcomes (8)
Things You Do - 15 (TYD-15)
A measure of behaviors associated with mental health. 15 items are measured on a 5-point Likert scale ranging from 0-4. Subscales include Routine, Thoughts, Social, Activity, and Goals. Scores are summed into subscale scores ranging from 0 to 12, and a total score ranging from 0 to 60, with higher scores indicating increased engagement in behaviours associated with mental health.
Measured: Baseline (Screening), weeks 4, 8, and 20 from enrollment
Lubben Social Network Scale - 6 items (LSNS-6)
A measure assessing perceived social network and support using 6 items, with two subscales (Family and Friendship). Each subscale contains 3-items, measured on a 6-point Likert scale ranging from 0-5. Items on each subscale are summed to produce a subscale score ranging from 0 to 15. A total scale score ranges from 0 to 30. Higher scores indicate greater perceived support in each subscale or global scale.
Measured: Baseline (Screening), weeks 8 and 20 from enrollment
Brief Social Support Scale (BS-6)
The BS-6 is a measure of perceived social support, with two subscales (emotional-informational and tangible social support). Each subscale contains 3-items. The first three items of the scale assess perceived tangible support and the remaining three items assess perceived emotional-informational social support. Items are measured on a 4-point Likert scale ranging from 1-4, with subscale scores ranging from 3 to 12, and global scores ranging from 6 to 24. Higher scores indicate greater perceived social support.
Measured: Baseline (Screening) weeks 8 and 20 from enrollment
Mini Social Phobia Inventory (Mini SPIN)
Measures symptoms of social anxiety. 3 items are measured on a 5-point Likert scale ranging from 0 to 4. Scored are summed into a total score ranging from 0-12, with higher scores indicating greater symptoms of social anxiety.
Measured: Baseline (Screening), weeks 8 and 20 from enrollment
Work and Social Adjustment Scale (WSAS)
The WSAS is a measure of functional impairment experienced in different interpersonal and intrapersonal domains due to mental health. Includes 5 items rated on a 9-point Likert scale ranging from 0-8. Scores are summed to produce a total score between 0-40. Higher scores indicate greater impairment in functioning.
Measured: Baseline (Screening), weeks 8 and 20 from enrollment
Treatment Credibility and Expectancy Questionnaire (CEQ)
Measures treatment credibility and expectancy using 6 items, with two subscales. First three items correspond to the credibility subscale and the following three items correspond to the expectancy subscale. Items are measured on 9-point Likert scale ranging from 1-9. Subscale scores range from 3 to 27. Higher scores in each subscale indicate greater treatment credibility or treatment expectancy respectively
Measured: Baseline (Screening) and week 4
Treatment Satisfaction Questionnaire
A 15-item questionnaire used to assess satisfaction with treatment and negative effects experienced by clients during treatment. The questionnaire uses a combination of Likert scale [5-point (0-4) and 6-point (0-5)], open-ended, and dichotomous yes/no response options to gauge participants' perceptions of the course. The questionnaire has been developed by the research team. A total score is not produced for this measure.
Measured: Week 8
Loneliness Content Satisfaction
A bespoke 4-item measure administered to clients in the Wellbeing Course plus Loneliness Resource arm. The questionnaire uses a combination of dichotomous yes/no, Likert scale, and open-ended response option items to understand participants perceptions of the content. The questionnaire was developed by the research team and no total score is produced.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start18 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 494 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Saskatchewan, Ministry of Health, Linkoeping University, Macquarie University, Australia
- Responsible party
- Sponsor
- Investigators
- Heather Hadjistavropoulos, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095582
- Sponsor's protocol ID
- 1086
- Status last verified
- Apr 2026
- First submitted
- 23 Jul 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Therapist-Guided Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety With Additional Content
- ClinicalTrials.gov ID
- NCT07095582
- Acronym / sponsor ID
- 1086
- Conditions
- Loneliness, Depression, Anxiety
- Keywords
- Loneliness, Depression, Anxiety, Internet-delivered cognitive behavioral therapy, Randomized controlled trial, Personalized therapy, Therapist assistance, Mental health system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 494 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Government of Saskatchewan, Ministry of Health, Linkoeping University, Macquarie University, Australia
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Depression and anxiety are prevalent mental health conditions that are frequently under-treated. To improve timely and effective psychological treatment, Internet-delivered Cognitive Behaviour Therapy (ICBT) has been developed as a scalable treatment option. ICBT delivers evidence-based therapeutic content via structured online lessons over the course of several months, teaching the same skills as face-to-face cognitive behaviour therapy. In routine practice, ICBT is typically accompanied by brief therapist guidance offered via secure messaging and/or phone calls.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wellbeing Course (No Loneliness Content) | Active comparator | Behavioral: Internet-delivered cognitive behavioral therapyAll 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. |
| Wellbeing Course plus Loneliness Content | Experimental | Behavioral: Internet-delivered cognitive behavioral therapy, Behavioral: Additional Loneliness ContentDue 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-delivered cognitive behavioral therapyThe 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. | Behavioural | Wellbeing Course (No Loneliness Content), Wellbeing Course plus Loneliness Content |
| Additional Loneliness ContentThe 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. | Behavioural | Wellbeing Course plus Loneliness Content |
Primary outcome
UCLA Loneliness Scale 3-item (UCLA-3)
Time frame: Baseline (Screening), weeks 4, 8 and 20 from enrollment
Measures loneliness. 3 items are measured on a 3-point Likert scale ranging from 1-3. Scores are summed into a total score ranging from 3 to 9, with higher scores indicating higher levels of perceived loneliness.
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: Baseline (Screening), weeks 1-8 and 20 from enrollment
Tracking the change in depression symptoms. 9 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed with total scores ranging from 0 to 27. Higher scores are associated with higher depression severity.
Generalized Anxiety Disorder - 7 (GAD-7)
Time frame: Baseline (Screening), weeks 1-8 and 20 from enrollment
Tracking the change in anxiety symptoms. 7 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.
8 secondary outcomes
Things You Do - 15 (TYD-15)
Time frame: Baseline (Screening), weeks 4, 8, and 20 from enrollment
Lubben Social Network Scale - 6 items (LSNS-6)
Time frame: Baseline (Screening), weeks 8 and 20 from enrollment
Brief Social Support Scale (BS-6)
Time frame: Baseline (Screening) weeks 8 and 20 from enrollment
Mini Social Phobia Inventory (Mini SPIN)
Time frame: Baseline (Screening), weeks 8 and 20 from enrollment
Work and Social Adjustment Scale (WSAS)
Time frame: Baseline (Screening), weeks 8 and 20 from enrollment
Treatment Credibility and Expectancy Questionnaire (CEQ)
Time frame: Baseline (Screening) and week 4
Treatment Satisfaction Questionnaire
Time frame: Week 8
Loneliness Content Satisfaction
Time frame: Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather Hadjistavropoulos, PhD principal investigator
University of Regina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered cognitive behavioral therapy and Additional Loneliness Content in people with Loneliness and Depression, run by University of Regina at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcie Nugent, MSW (306-337-3331, marcie.nugent@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCLA Loneliness Scale 3-item (UCLA-3) (time frame: Baseline (Screening), weeks 4, 8 and 20 from enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.