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

Not Applicable

Recruiting

• Conditions: Depression; Anxiety

• Registration Number: NCT05333627
• Lead Sponsor: University of Regina

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-11
• Study First Posted: 2022-04-19
• Study Start: 2022-05-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder 7-item (GAD-7)	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.
Patient Health Questionnaire 9-item (PHQ-9)	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.
Perceptions of Academic Functioning (PAF)	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 Outcome Measures

Name	Time	Method
Treatment Satisfaction	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
Work and Social Adjustment Scale (WSAS)	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.
Credibility and Expectancy Questionnaire (CEQ)	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.

Trial Locations

Locations (1)

Online Therapy Unit, University of Regina; 🇨🇦 Regina, Saskatchewan, Canada