Recruiting

Cognitive Behaviour Therapy

Sponsor:

University of Regina

Code:

NCT05333627

Conditions

Depression

Anxiety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Wellbeing Course for Students (Fast Track)

Wellbeing Course for Students (5 weeks)

Wellbeing Course (8 weeks)

Study Details

Brief summary:

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.

Conditions

Depression

Anxiety

Study ID

NCT05333627

Start date

Nov 1, 2020

Status verified date

Apr, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • registered as a student at a post-secondary institution in Saskatchewan; over the age of 18; endorse symptoms of depression (score of 5 or greater on the PHQ-9) and/or anxiety (score of 5 or greater on the GAD-7); and be able to access computers and the Internet and be comfortable using them

Exclusion Criteria:

  • high risk of suicide or hospitalization for mental health in previous 12 months; unmanaged alcohol or drug use problems; severe psychiatric illness that is not managed (e.g. psychosis or mania); or receiving other psychological services more than twice per month

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fast-Track Course

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.

experimental: 5-Week Course

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.

experimental: 8-Week Course

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.

Interventions

Wellbeing Course for Students (Fast Track)

The core Fast-Track lesson includes information on managing their cycle of symptoms, motivation, and an overview of strategies that can be used to manage symptoms of depression and anxiety. After the core lesson, clients can access three additional Do-It-Yourself guides that focus on thought challenging, controlled breathing/activity planning, and behavioural activation/relapse prevention. These materials are able to be accessed out of sequence on a schedule that suits their needs. With optional therapist support, therapists will respond to any messages that clients send once per week. Therapists will not message clients on weeks where the client does not send a message.

Wellbeing Course for Students (5 weeks)

The 5-week course consists of four lessons that provide psychoeducation about: symptom identification and the cognitive behavioural model, thought monitoring and challenging, controlled breathing and pleasant activity scheduling, graded exposure, and relapse prevention. With optional therapist support, therapists will respond to any messages that clients send once per week. Therapists will not message clients on weeks where the client does not send a message.

Wellbeing Course (8 weeks)

The 8-week course consists of five lessons that provide psychoeducation about: symptom identification and the cognitive behavioural model, thought monitoring and challenging, controlled breathing and pleasant activity scheduling, graded exposure, and relapse prevention. With optional therapist support, therapists will respond to any messages that clients send once per week. Therapists will not message clients on weeks where the client does not send a message.

Primary outcome measure

  • Patient Health Questionnaire 9-item (PHQ-9) [ Time Frame: Baseline (screening), weeks 1-5 (Fast-Track and 5-week course), weeks 1-8 (8-week course), and week 16 (all course options) ]
  • Generalized Anxiety Disorder 7-item (GAD-7) [ Time Frame: Baseline (screening), weeks 1-5 (Fast-Track and 5-week course), weeks 1-8 (8-week course), and week 16 (all course options) ]
  • Perceptions of Academic Functioning (PAF) [ Time Frame: Baseline (screening), weeks 1-5 (Fast-Track and 5-week course), weeks 1-8 (8-week course), and week 16 (all course options) ]

Central Contacts and Locations

Central contacts

Marcie Nugent, MSW

3063372946marcie.nugent@uregina.ca

Heather Hadjistavropoulos, PhD

3065855133hadjista@uregina.ca

Locations

Online Therapy Unit, University of Regina

Recruiting

Regina, Saskatchewan, Canada, S4S 0A2

Contacts

Marcie Nugent, MSW

3063373331marcie.nugent@uregina.ca

Principal Investigator:

Heather Hadjistavropoulos, PhD

More Information

Sponsor

University of Regina

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • anxiety
  • depression
  • post-secondary students
  • internet-delivered cognitive behaviour therapy
  • transdiagnostic
  • preference trial

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 2026-05-05.