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Recruiting NCT05333627

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

No phase Interventional Depression Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Wellbeing Course for Students (Fast Track), Wellbeing Course for Students (5 weeks), Wellbeing Course (8 weeks).
Who it may be relevant to
Registry conditions: Depression, Anxiety. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral Wellbeing 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
  • Behavioral Wellbeing 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.
  • Behavioral Wellbeing 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.

Primary outcome measures

  • 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)]
  • 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)]
  • 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)]
Secondary outcome measures (3)
  • Credibility and Expectancy Questionnaire (CEQ) [Time frame: Baseline (screening), week 5 (Fast-Track and 5-week course), week 8 (8-week course)]
  • Treatment Satisfaction [Time frame: Week 5 (Fast-Track and 5-week course); Week 8 (8-week course)]
  • Work and Social Adjustment Scale (WSAS) [Time frame: Baseline (screening), week 5 (Fast-Track and 5-week course), week 8 (8-week course)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Online Therapy Unit, University of Regina — Regina

Identifiers

NCT: NCT05333627 · 2019-205b

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗