NCT05333627

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
12mo left

Started Nov 2020

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Nov 2020Apr 2027

Study Start

First participant enrolled

November 1, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

6.5 years

First QC Date

April 11, 2022

Last Update Submit

April 28, 2026

Conditions

Keywords

anxietydepressionpost-secondary studentsinternet-delivered cognitive behaviour therapytransdiagnosticpreference trial

Outcome Measures

Primary Outcomes (3)

  • Patient Health Questionnaire 9-item (PHQ-9)

    Change in depression symptoms. 9 items are summed into a total score, with scores ranging from 0 to 27. Higher scores are associated with higher depression severity.

    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)

    Change in anxiety symptoms. 7 items 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 1-5 (Fast-Track and 5-week course), weeks 1-8 (8-week course), and week 16 (all course options)

  • Perceptions of Academic Functioning (PAF)

    Change in subjective academic functioning. 3 items are summed into a total score ranging from 0 to 30, with higher scores indicating higher perceived functioning.

    Baseline (screening), weeks 1-5 (Fast-Track and 5-week course), weeks 1-8 (8-week course), and week 16 (all course options)

Secondary Outcomes (3)

  • Credibility and Expectancy Questionnaire (CEQ)

    Baseline (screening), week 5 (Fast-Track and 5-week course), week 8 (8-week course)

  • Treatment Satisfaction

    Week 5 (Fast-Track and 5-week course); Week 8 (8-week course)

  • Work and Social Adjustment Scale (WSAS)

    Baseline (screening), week 5 (Fast-Track and 5-week course), week 8 (8-week course)

Other Outcomes (2)

  • Alcohol Use Disorder Identification Test (AUDIT)

    Baseline (screening)

  • Drug Use Disorder Identification Test (DUDIT)

    Baseline (screening)

Study Arms (3)

Fast-Track Course

EXPERIMENTAL

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.

Behavioral: Wellbeing Course for Students (Fast Track)

5-Week Course

EXPERIMENTAL

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.

Behavioral: Wellbeing Course for Students (5 weeks)

8-Week Course

EXPERIMENTAL

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.

Behavioral: Wellbeing Course (8 weeks)

Interventions

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.

Fast-Track Course

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.

8-Week Course

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.

5-Week Course

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Online Therapy Unit, University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Vanessa Peynenburg, MA

    University of Regina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcie Nugent, MSW

CONTACT

Heather Hadjistavropoulos, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Each client will choose one of the following: Wellbeing Course for Students (Fast-Track), Wellbeing Course for Students (5 weeks), and Wellbeing Course (8 weeks)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 19, 2022

Study Start

November 1, 2020

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations