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NCT Number: NCT05333627

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

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Online Therapy Unit, University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Location status: Recruiting

Location contact

Heather Hadjistavropoulos, PhD

PRINCIPAL_INVESTIGATOR

Marcie Nugent, MSW

CONTACT

[email protected]

3063373331

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wellbeing Course for Students (Fast Track)

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.

Wellbeing Course for Students (5 weeks)

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.

Wellbeing Course (8 weeks)

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.

Primary outcomes

  1. 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)

    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.

  2. 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)

    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.

  3. 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)

    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.

Secondary outcomes

  1. Credibility and Expectancy Questionnaire (CEQ)

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

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

  2. Treatment Satisfaction

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

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

  3. Work and Social Adjustment Scale (WSAS)

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

    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.

Other outcomes

  1. Alcohol Use Disorder Identification Test (AUDIT)

    Time frame: Baseline (screening)

    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.

  2. Drug Use Disorder Identification Test (DUDIT)

    Time frame: Baseline (screening)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Hadjistavropoulos, PhD

CONTACT

[email protected]

3065855133

Marcie Nugent, MSW

CONTACT

[email protected]

3063372946

Sponsors and collaborators

Lead sponsor

University of Regina

Other

Collaborators

  • Ministry of Health, Saskatchewan

Registry information

Official study title

Internet-delivered Cognitive Behaviour Therapy for Post-Secondary Students: Preference Trial for Flexible, 5-Week, and 8-Week Options

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Apr 19, 2022
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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