Recruiting

Wellbeing Course

Sponsor:

University of Regina

Code:

NCT07095582

Conditions

Loneliness

Depression

Anxiety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Internet-delivered cognitive behavioral therapy

Additional Loneliness Content

Study Details

Brief 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.

Conditions

Loneliness

Depression

Anxiety

Study ID

NCT07095582

Start date

Jun 18, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

494 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

Interventions

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.

Primary outcome measure

  • UCLA Loneliness Scale 3-item (UCLA-3) [ Time Frame: Baseline (Screening), weeks 4, 8 and 20 from enrollment ]
  • Patient Health Questionnaire - 9 (PHQ-9) [ Time Frame: Baseline (Screening), weeks 1-8 and 20 from enrollment ]
  • Generalized Anxiety Disorder - 7 (GAD-7) [ Time Frame: Baseline (Screening), weeks 1-8 and 20 from enrollment ]

Central Contacts and Locations

Central contacts

Marcie Nugent, MSW

306-337-3331marcie.nugent@uregina.ca

Heather Hadjistavropoulos, PhD

306-585-5133heather.hadjistavropoulos@uregina.ca

Locations

Online Therapy Unit

Recruiting

Regina, Saskatchewan, Canada, S4S 0A2

Contacts

Marcie Nugent, MSW

306-337-3331marcie.nugent@uregina.ca

Heather Hadjistavropoulos, PhD

306-585-5133heather.hadjistavropoulos@uregina.ca

Online Therapy Unit

Recruiting

Regina, Saskatchewan, Canada, S4S0A2

Contacts

Marcie Nugent, MSW

306-337-3331marcie.nugent@uregina.ca

Heather Hadjistavropoulos, PhD

306-585-5133heather.hadjistavropoulos@uregina.ca

Principal Investigator:

Heather Hadjistavropoulos, PhD

More Information

Sponsor

University of Regina

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • Loneliness
  • Depression
  • Anxiety
  • Internet-delivered cognitive behavioral therapy
  • Randomized controlled trial
  • Personalized therapy
  • Therapist assistance
  • Mental health system

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Regina on 2026-04-29.