Internet-delivered Cognitive Behaviour Therapy for Students: Duration Preference Trial

NCT ID: NCT05333627

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-09
• Study Completion Date: 2025-12-31

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Wellbeing Course for Students (Fast Track)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Wellbeing Course for Students (5 weeks)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Wellbeing Course (8 weeks)

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Saskatchewan

OTHER

Sponsor Role: collaborator

University of Regina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vanessa Peynenburg, MA

Role: PRINCIPAL_INVESTIGATOR

University of Regina

Locations

Online Therapy Unit, University of Regina

Regina, Saskatchewan, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Marcie Nugent, MSW

Role: CONTACT

marcie.nugent@uregina.ca

3063372946

Heather Hadjistavropoulos, PhD

Role: CONTACT

hadjista@uregina.ca

3065855133

Facility Contacts

Marcie Nugent, MSW

Role: primary

marcie.nugent@uregina.ca

3063373331

Other Identifiers

2019-205b

Identifier Type: -

Identifier Source: org_study_id