Enhancing Internet-Delivered Cognitive Behaviour Therapy With Additional Content

NCT07095582 | Recruiting

• 1 other identifier: 1086
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline (Screening), weeks 1-8 and 20 from enrollment

Secondary Outcomes (8)

• Things You Do - 15 (TYD-15)

  Baseline (Screening), weeks 4, 8, and 20 from enrollment

• Lubben Social Network Scale - 6 items (LSNS-6)

  Baseline (Screening), weeks 8 and 20 from enrollment

• Brief Social Support Scale (BS-6)

  Baseline (Screening) weeks 8 and 20 from enrollment

• Mini Social Phobia Inventory (Mini SPIN)

  Baseline (Screening), weeks 8 and 20 from enrollment

• Work and Social Adjustment Scale (WSAS)

  Baseline (Screening), weeks 8 and 20 from enrollment

Other Outcomes (2)

• Mental Health Service Use

  Baseline (Screening), 20 weeks from enrollment

• Homework Reflection Questionnaire

  Weeks 2 to 8

Study Arms (2)

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.

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.

Behavioral: Internet-delivered cognitive behavioral therapy; Behavioral: Additional Loneliness Content

Interventions

Internet-delivered cognitive behavioral therapy BEHAVIORAL

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 (No Loneliness Content); Wellbeing Course plus Loneliness Content

Additional Loneliness Content BEHAVIORAL

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.

Wellbeing Course plus Loneliness Content

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Regina: lead
• Government of Saskatchewan, Ministry of Health: collaborator
• Linkoeping University: collaborator
• Macquarie University, Australia: collaborator

Study Sites (2)

Online Therapy Unit

Regina, Saskatchewan, S4S 0A2, Canada

RECRUITING

Online Therapy Unit

Regina, Saskatchewan, S4S0A2, Canada

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Heather Hadjistavropoulos, PhD

  University of Regina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcie Nugent, MSW

CONTACT

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

Heather Hadjistavropoulos, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 31, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)