Internet-Delivered Cognitive Behavioural Therapy for Loneliness

Overseen By Heather Hadjistavropoulos, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Regina

Disqualifiers: Severe psychiatric, Immediate surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

494 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding loneliness-focused content to an online therapy course can better assist individuals who feel lonely and experience depression or anxiety. Participants will use internet-delivered cognitive behavioral therapy (ICBT), with some receiving additional materials to address loneliness. The goal is to determine if this added content enhances engagement and treatment outcomes. It is suitable for Saskatchewan residents, 18 or older, who frequently feel lonely, struggle with depression or anxiety, and have internet access. As an unphased trial, this study provides a unique opportunity to contribute to innovative mental health solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on online therapy for mental health, so it's best to check with the trial organizers or your doctor.

What prior data suggests that this internet-delivered cognitive behavioral therapy is safe?

Research has shown that internet-delivered cognitive behavioral therapy (ICBT) is generally safe and easy to use. Studies have found that ICBT can greatly reduce feelings of loneliness, with lasting benefits. Participants often report positive experiences and find the therapy helpful for their loneliness.

No specific reports of serious side effects from ICBT for loneliness exist. People using this therapy have seen improvements in depression, anxiety, and loneliness without major problems. This suggests that ICBT, even with extra focus on loneliness, is a safe option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about internet-delivered cognitive behavioral therapy (ICBT) for loneliness because it offers a unique and accessible approach to tackling loneliness. Unlike traditional in-person therapy, this method is delivered online, making it more convenient and accessible for people who may have difficulties attending regular therapy sessions. The inclusion of specific content addressing loneliness, alongside general wellbeing lessons, provides targeted psychoeducation and coping skills, which are not typically part of standard therapy options. Additionally, the flexible therapist support, extendable up to 12 weeks, ensures that participants receive tailored assistance, potentially enhancing the effectiveness of the treatment.

What evidence suggests that this trial's treatments could be effective for loneliness?

Research has shown that online cognitive behavioral therapy (ICBT) can help reduce loneliness. In this trial, participants will join one of two groups: the Wellbeing Course with additional loneliness content or the Wellbeing Course without it. Studies have found that including specific content about loneliness in ICBT enhances its effectiveness. For instance, ICBT with loneliness-focused content significantly reduces loneliness compared to standard ICBT alone. Guidance from a therapist during the program further improves these positive outcomes. Overall, this method shows promise in helping people feel less isolated and more connected. ^{4 6 7 8 9}

Who Is on the Research Team?

Heather Hadjistavropoulos, PhD

Principal Investigator

University of Regina

Are You a Good Fit for This Trial?

This trial is for individuals feeling lonely and experiencing symptoms of depression or anxiety. Participants should be seeking treatment and willing to engage with an online therapy program over 8 weeks. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions.

Inclusion Criteria

Willingness to learn information and skills to self-manage mental health difficulties

Saskatchewan resident

I am 18 years old or older.

Exclusion Criteria

I can read and understand English.

I do not have any severe medical or psychiatric conditions needing immediate treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants receive the Wellbeing Course with or without additional loneliness content over 8 weeks, with therapist support

8 weeks

Weekly online lessons

Extended Support

Optional extended therapist support for up to 12 weeks if requested and clinically indicated

Up to 12 weeks

Follow-up

Participants are monitored for changes in loneliness, depression, and anxiety symptoms

12 weeks

Questionnaires at weeks 4, 8, and 20

Booster Session

A booster session is offered to review progress and explore techniques for maintaining well-being

1 session

What Are the Treatments Tested in This Trial?

Interventions

• Additional Loneliness Content
• Internet-delivered Cognitive Behavioral Therapy

Trial Overview The study tests if adding loneliness-focused content to an existing internet-delivered cognitive behavioral therapy (ICBT) improves engagement, satisfaction, and outcomes in treating depression and anxiety compared to the standard ICBT course alone.

How Is the Trial Designed?

Group I: Wellbeing Course plus Loneliness Content Experimental Treatment 2 Interventions

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.

Group II: Wellbeing Course (No Loneliness Content) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Regina

Lead Sponsor

Trials

59

Recruited

9,100+

Linkoeping University

Collaborator

Trials

293

Recruited

3,517,000+

Macquarie University, Australia

Collaborator

Trials

27

Recruited

27,100+

Government of Saskatchewan, Ministry of Health

Collaborator

Trials

1

Recruited

60+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41129367/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=0E40SvnXVx18HK6hTslFhS95Tp43EoL-bC0Fo2EQgvZ&fc=None&ff=20251028012842&v=2.18.0.post22+67771e2

Exploring the influence of loneliness and social isolation in ... Conclusions: Overall, results indicate that loneliness and social isolation are prevalent among clients seeking ICBT and both decrease during ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S221478292300101X

Predictors and moderators of outcome of ICBT for ... Internet-based cognitive behavioral therapy (ICBT) is promising in alleviating loneliness in adults. Identifying individuals who benefit from ICBT for ...

3. nature.com nature.com/articles/s41598-024-57254-0

Efficacy of an Internet-based self-help intervention with ... ICBT effectively alleviated loneliness, and guidance increased the reduction in loneliness compared to automated messages.

4. psycnet.apa.org psycnet.apa.org/record/2026-78292-002

Exploring the influence of loneliness and social isolation in ... Exploring the influence of loneliness and social isolation in transdiagnostic internet-delivered cognitive behavioral therapy for depression and anxiety.

5. karger.com karger.com/pps/article/90/5/351/829011/Therapist-Guided-Internet-Based-Treatments-for

A Randomized Controlled Three-Arm Trial Comparing ... To investigate the efficacy of 2 internet-based interventions based on cognitive behavioral therapy (ICBT) and interpersonal psychotherapy (IIPT)

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10772709/

Predictors and moderators of outcome of ICBT for ... Feeling less burdened by loneliness resulted in higher odds of reliable improvement in guided ICBT compared to the waitlist-control condition.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2214782919301265

Lonesome no more? A two-year follow-up of internet ... The results of the study support the utility of internet-based CBT targeting loneliness and indicate that the benefits from the intervention can be enduring.

8. formative.jmir.org formative.jmir.org/2023/1/e51088

Internet-Delivered Cognitive Behavioral Therapy Tailored to ... This study aimed to assess the initial use and client perceptions (eg, likes, helpfulness, and areas for improvement) of a self-guided, transdiagnostic ICBT ...

9. frontiersin.org frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2025.1504217/full

Internet-based cognitive behavioral therapy for ... Results: Statistically significant improvements were observed in symptoms of depression, anxiety, post-traumatic stress, loneliness, and exhaustion. Small ...