Clinical trial NCT05333627: Internet-delivered Cognitive Behaviour Therapy for Students: Duration Preference Trial
Official title: Internet-delivered Cognitive Behaviour Therapy for Post-Secondary Students: Preference Trial for Flexible, 5-Week, and 8-Week Options
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Keywords: anxiety
depression
post-secondary students
internet-delivered cognitive behaviour therapy
transdiagnostic
preference trial
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Saskatchewan
First posted: 2022-04-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Patient Health Questionnaire 9-item (PHQ-9)
timeFrame: Baseline (screening), weeks 1-5 (Fast-Track and 5-week course), weeks 1-8 (8-week course), and week 16 (all course options)
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Baseline (screening), weeks 1-5 (Fast-Track and 5-week course), weeks 1-8 (8-week course), and week 16 (all course options)
measure: Perceptions of Academic Functioning (PAF)
timeFrame: 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:
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Baseline (screening), week 5 (Fast-Track and 5-week course), week 8 (8-week course)
measure: Treatment Satisfaction
timeFrame: Week 5 (Fast-Track and 5-week course); Week 8 (8-week course)
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Baseline (screening), week 5 (Fast-Track and 5-week course), week 8 (8-week course)
Other outcomes:
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Baseline (screening)
measure: Drug Use Disorder Identification Test (DUDIT)
timeFrame: Baseline (screening)
Locations:
city: Regina
country: Canada
facility: Online Therapy Unit, University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Vanessa Peynenburg, MA
role: PRINCIPAL_INVESTIGATOR
References: