Online Cognitive Behavioural Therapy for Student Mental Health

Overseen By Marcie Nugent, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Regina

Disqualifiers: High suicide risk, Unmanaged substance use, Severe psychiatric illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5-8 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

There is growing evidence for the effectiveness of internet-delivered cognitive behaviour therapy (ICBT) for post-secondary students with symptoms of depression and anxiety. In ICBT, clients review structured online content over several weeks to learn strategies and skills to manage their symptoms. Low treatment completion rates remain a concern for post-secondary students, so it is possible that existing treatment protocols do not offer enough flexibility for students' needs and preferences. This trial will examine students' preferences for different course options (fast-track, 5-week, and 8-week) and compare enrollment, adherence, and outcomes of students who pick each of the three options. In all three options, students will receive optional therapist support, in which the assigned therapist only contacts the student on weeks where the student sends the therapist a message. This trial will help inform the delivery of flexible treatment options for post-secondary students in a routine care setting.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It focuses on online therapy for depression and anxiety, so it's best to discuss your medications with the trial team or your doctor.

What data supports the effectiveness of the treatment Wellbeing Course, Wellbeing Course for Students in the clinical trial for Online Cognitive Behavioural Therapy for Student Mental Health?

The English Improving Access to Psychological Therapies (IAPT) service, which provides psychological therapies for depression and anxiety, shows that routine mental health services can effectively monitor and report patient outcomes, suggesting that similar approaches like the Wellbeing Course could be beneficial for students' mental health. ^{1 2 3 4 5}

Is online cognitive behavioural therapy safe for students?

The Wellbeing Plus Course, a similar internet-delivered therapy for older adults with anxiety and depression, has been implemented in routine clinical care, suggesting it is generally safe for use in humans. ^{6 7 8 9 10}

How does the Wellbeing Course for Students treatment differ from other treatments for student mental health?

The Wellbeing Course for Students is unique because it is an online cognitive behavioral therapy (CBT) specifically designed for students, which can improve access to mental health care and includes motivational interviewing and booster lessons to enhance engagement and outcomes. ^{11 12 13 14 15}

Research Team

Vanessa Peynenburg, MA

Principal Investigator

University of Regina

Eligibility Criteria

This trial is for post-secondary students in Saskatchewan over 18 years old who are experiencing symptoms of depression or anxiety. Participants must be comfortable using computers and the Internet. It's not suitable for those at high risk of suicide, with recent hospitalization for mental health, unmanaged substance issues, severe psychiatric conditions like psychosis or mania, or receiving frequent psychological services.

Inclusion Criteria

Be able to access computers and the Internet and be comfortable using them

I am over 18 years old.

I am experiencing symptoms of depression or anxiety.

Exclusion Criteria

I see a therapist or counselor more than twice a month.

Severe psychiatric illness that is not managed (e.g. psychosis or mania)

High risk of suicide or hospitalization for mental health in previous 12 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Baseline

Treatment

Participants receive internet-delivered cognitive behaviour therapy (ICBT) with options for Fast-Track (5 weeks), 5-week, or 8-week courses, including optional therapist support.

5-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at week 16 for all course options.

8 weeks

Treatment Details

Interventions

• Wellbeing Course
• Wellbeing Course for Students

Trial Overview The study tests three durations of an internet-delivered cognitive behaviour therapy (ICBT) course: a fast-track option, a 5-week course, and an 8-week course. All options include optional therapist support based on student engagement. The trial aims to determine which duration best suits students' needs by comparing enrollment rates and treatment outcomes.

Participant Groups

Group I: Fast-Track Course Experimental Treatment 1 Intervention

Clients who select the Fast-Track Course option will receive access to a single ICBT core lesson and Do-It-Yourself guide, followed by three additional Do-It-Yourself guides that they can access in any order. The content includes examples that are tailored to students' experiences. Clients have access to diverse additional resources (e.g., managing panic, assertive communication) throughout the course. Clients will receive up to five weeks of optional therapist support.

Group II: 8-Week Course Experimental Treatment 1 Intervention

Clients who select the 8-week course will receive access to an ICBT course which consists of five lessons spread across the span of eight weeks. The content in this course is not student-specific. Clients have access to diverse additional resources (e.g., managing panic, assertive communication) throughout the course. Clients will receive eight weeks of optional therapist support.

Group III: 5-Week Course Experimental Treatment 1 Intervention

Clients who select the 5-week course will receive access to an ICBT course which consists of four lessons spread across the span of five weeks. The content includes examples that are tailored to students' experiences. Clients have access to diverse additional resources (e.g., managing panic, assertive communication) throughout the course. Clients will receive five weeks of optional therapist support.

Who Is Running the Clinical Trial?

University of Regina

Lead Sponsor

Trials

59

Recruited

9,100+

Ministry of Health, Saskatchewan

Collaborator

Trials

4

Recruited

2,800+

Saskatchewan Ministry of Health

Collaborator

Trials

4

Recruited

2,800+

Findings from Research

The Improving Access to Psychological Therapies (IAPT) service in the UK effectively monitors and reports clinical outcomes for over 537,000 patients annually, revealing that specific organizational factors, such as the number of treatment sessions and timely access to care, significantly predict better mental health outcomes.

Improvements in service organization could enhance clinical outcomes by 11-42%, indicating that how psychological therapies are delivered is as crucial as the treatments themselves, and this model could be beneficial for mental health services globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transparency about the outcomes of mental health services (IAPT approach): an analysis of public data. Clark, DM., Canvin, L., Green, J., et al.[2023]

In a study involving 308 postsecondary students undergoing internet-delivered cognitive behavioral therapy (ICBT), 54% completed the treatment, showing significant improvements in depression and anxiety symptoms that were sustained at 1 and 3 months post-treatment.

While motivational interviewing (MI) before treatment did not enhance completion rates, students who accessed self-guided booster lessons after treatment experienced greater reductions in depressive symptoms, suggesting that timing and support for boosters may be crucial for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Postsecondary Students: Randomized Factorial Trial for Examining Motivational Interviewing and Booster Lessons. Peynenburg, V., Hadjistavropoulos, H., Thiessen, D., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Quality assurance of outcome in mental health care: a model for routine use in clinical settings. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Clinical audit of behaviour therapy training of nurses. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Effects of inpatient client-centered psychotherapy in various illness: 1-year follow-up]. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Transparency about the outcomes of mental health services (IAPT approach): an analysis of public data. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The effect of process and outcome feedback in highly distressed outpatients: A randomized controlled trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Wellness and resilience for college and beyond: protocol for a quasi-experimental pilot study investigating a dialectical behaviour therapy skill-infused college course. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Positive psychology psychoeducation makes a small impact on undergraduate student mental health: Further curriculum innovation and better well-being research needed. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Teaching well-being at scale: An intervention study. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Issuing Well-being Challenges to Nudge Pharmacy Students to Adopt Well-being Protective Behaviors. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Internet-delivered treatment for older adults with anxiety and depression: implementation of the Wellbeing Plus Course in routine clinical care and comparison with research trial outcomes. [2020]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Mental distress and well-being of university students amid COVID-19 pandemic: findings from an online integrative intervention for psychology trainees. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Effect of online counselling on emotional outcomes during the COVID-19 pandemic: An innovative group intervention for university students using the Brain Wave Modulation Technique. [2022]

13. Canada pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Postsecondary Students: Randomized Factorial Trial for Examining Motivational Interviewing and Booster Lessons. [2022]

14. Switzerland pubmed.ncbi.nlm.nih.gov

An Evaluation of an Online Brief Mindfulness-Based Intervention in Higher Education: A Pilot Conducted at an Australian University and a British University. [2021]

15. England pubmed.ncbi.nlm.nih.gov

Think your way out. [2018]