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Clinical Trials/NCT05333627
NCT05333627
Recruiting
Not Applicable

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

University of Regina1 site in 1 country200 target enrollmentMay 9, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University of Regina
Enrollment
200
Locations
1
Primary Endpoint
Generalized Anxiety Disorder 7-item (GAD-7)
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 9, 2022
End Date
December 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

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.

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

  • 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))
  • Credibility and Expectancy Questionnaire (CEQ)(Baseline (screening), week 5 (Fast-Track and 5-week course), week 8 (8-week course))

Study Sites (1)

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