ClinicalTrials.gg
RecruitingNCT05333627Updated May 5, 2026

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

An interventional study of Wellbeing Course for Students (Fast Track) and Wellbeing Course for Students (5 weeks) in Depression and Anxiety, sponsored by University of Regina. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by University of Regina · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Nov 2020, registered Apr 2022).
  • Started Nov 2020; still recruiting 6 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 33 studies in Depression by University of Regina — 12 open to participants now, 12 under way, none of them phase 3. Depression · University of Regina.

Planned enrollment
12th of 31
200 · median 158
Started
2020
with 5 others
No phase
29 of 33
12 open now
Primary completion
2027-04
later than 5 of 11 live
Registered
20th of 33
by date

Among the 33 studies in Depression by University of Regina, this one is the 12th largest by planned enrollment of the 31 interventional ones that give a count, is one of 6 that started in 2020, is one of 29 with no phase, reaches primary completion later than 5 of the 11 other live ones, and was the 20th registered.

Depression

8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.

Browse Depression studies →

Open to participants now

12 of the 33 studies in Depression by University of Regina are open now, in 1 country. Recruiting first, the newest first:

6 more — sign in →

By country, each count listing its studies:

All 12 open studies →

Where they have run

Who these studies take

Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Depression
  • Anxiety

Keywords

  • anxiety
  • depression
  • post-secondary students
  • internet-delivered cognitive behaviour therapy
  • transdiagnostic
  • preference trial
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study 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.

    Behavioral: Wellbeing Course for Students (Fast Track)

  • 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.

    Behavioral: Wellbeing Course for Students (5 weeks)

  • 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.

    Behavioral: Wellbeing Course (8 weeks)

Interventions

  • BehavioralWellbeing 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.

  • BehavioralWellbeing 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.

  • BehavioralWellbeing 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.

06

What researchers measure

Primary outcomes

  1. 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.

    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)

  2. 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.

    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)

  3. 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.

    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)

Secondary outcomes

  1. Credibility and Expectancy Questionnaire (CEQ)

    Measure of treatment credibility. Three items range from 0-9 with higher scores indicating better outcome.

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

  2. Treatment Satisfaction

    Measure includes 19 questions assessing satisfaction with various aspects of Internet-CBT and also negative effects of treatment

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

  3. Work and Social Adjustment Scale (WSAS)

    Measure includes 5 questions assessing impairment of functioning. Items are scored on a scale of 0 to 8. Total scores on the WSAS range from 0 to 40 with higher scores suggesting severe impairment.

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

Other outcomes

  1. Alcohol Use Disorder Identification Test (AUDIT)

    A 10-item screening tool to assess alcohol consumption. Items 1 to 8 are scored on a scale ranging from 0 to 4. Items 9 and 10 are scored on a three-point scale (0, 2, or 4). Scores from 10 items are summed with possible scores ranging from 0 to 40 and higher scores indicating a higher likelihood of problematic alcohol consumption.

    Time frame: Baseline (screening)

  2. Drug Use Disorder Identification Test (DUDIT)

    An 11-item screening tool to assess problematic drug use. Items 1 to 9 are scored on a scale ranging from 0 to 4. Items 10 and 11 are scored as a 0, 2, or 4. Total scores for the DUDIT range from 0 to 44 with higher scores suggesting problematic drug use.

    Time frame: Baseline (screening)

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2020 (actual). Primary completion is estimated for Apr 2027, 77 months after the start.

Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 77 months is above that.

Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 11, 2022
First posted
Apr 19, 2022
StartActual
Nov 1, 2020
Primary completionEst.
Apr 30, 2027
CompletionEst.
Apr 30, 2027
Last update
May 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05333627
Lead sponsor
University of Regina
Collaborators
Ministry of Health, Saskatchewan
Responsible party
Sponsor
First posted
Apr 19, 2022
Start date
Nov 1, 2020
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
May 5, 2026

Study contacts

Marcie Nugent, MSW
Contact
marcie.nugent@uregina.ca
3063372946
Heather Hadjistavropoulos, PhD
Contact
hadjista@uregina.ca
3065855133
Vanessa Peynenburg, MA
principal investigator · University of Regina

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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