Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07095582

Enhancing Therapist-Guided Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety With Additional Content

Led by University of Regina · Updated on 2026-04-29

494

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Regina

Lead Sponsor

G

Government of Saskatchewan, Ministry of Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether adding extra content about loneliness to an internet-delivered cognitive behavioral therapy (ICBT) program can improve treatment outcomes for adults with symptoms of depression and anxiety who also experience frequent loneliness. The study focuses on clients seeking treatment through an online therapy clinic and aims to see if this additional loneliness-focused content enhances engagement, satisfaction, and symptom improvement compared to the standard Wellbeing Course alone. Participants will be randomly assigned to one of two groups: one receiving the Wellbeing Course only, and the other receiving the Wellbeing Course plus additional loneliness content. Both groups will complete 5 online lessons over 8 weeks and receive therapist support via secure messaging or phone calls, with possible extension up to 12 weeks. A booster session will be offered 12 weeks after treatment starts to review progress and strategies for maintaining well-being. During the study, participants will complete questionnaires at screening and at weeks 4, 8, and 20 to assess loneliness, depression, and anxiety levels. Additional assessments will include social network measures and treatment satisfaction. Therapists will monitor progress and provide support as needed. The total involvement may last up to 20 weeks, including follow-up, to track changes and lasting effects of the intervention.

CONDITIONS

Brief Title

Enhancing Internet-Delivered Cognitive Behaviour Therapy With Additional Content

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Total score on UCLA-3 is greater than 5 at screening
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening visit (online)

Treatment

Duration - 8 to 12 weeks

Participants receive the Wellbeing Course consisting of 5 online cognitive behavioural therapy lessons delivered gradually over 8 weeks, with therapist support offered throughout. Some participants receive additional loneliness content alongside the course. Therapist support may be extended up to 12 weeks if requested and clinically indicated.

Weekly online lessons with therapist support, plus 1 booster session at 12 weeks

Follow-up

Duration - Up to 12 weeks after treatment start (week 20)

Participants complete follow-up assessments to review progress and maintain well-being after treatment ends.

Follow-up assessments at weeks 20

Trial Site Locations

Total: 2 locations

1

Online Therapy Unit

Regina, Saskatchewan, Canada, S4S 0A2

Actively Recruiting

2

Online Therapy Unit

Regina, Saskatchewan, Canada, S4S0A2

Actively Recruiting

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Research Team

M

Marcie Nugent, MSW

H

Heather Hadjistavropoulos, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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