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

ConditionsDepression Anxiety

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Regina

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

200 Participants

are divided into 3 treatment groups

Group A: Fast-Track CourseExperimental treatment 1 intervention

Group B: 5-Week CourseExperimental treatment 1 intervention

Group C: 8-Week CourseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Patient Health Questionnaire 9-item (PHQ-9)

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.

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)

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.

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)

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.

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 outcomes

Credibility and Expectancy Questionnaire (CEQ)

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

Time frame

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

Treatment Satisfaction

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

Time frame

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

Work and Social Adjustment Scale (WSAS)

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.

Time frame

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

Other outcomes

Alcohol Use Disorder Identification Test (AUDIT)

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.

Time frame

Baseline (screening)

Drug Use Disorder Identification Test (DUDIT)

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.

Time frame

Baseline (screening)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Regina

Lead sponsor

Ministry of Health, Saskatchewan

Collaborator

Source ClinicalTrials.gov

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