Internet-delivered Cognitive Behaviour Therapy for Post-Secondary Students: Preference Trial for Various Course Durations

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05333627
• Other study ID #: 2019-205b
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: University of Regina
• Contact: Marcie Nugent, MSW
• Phone: 3063372946
• Email: marcie.nugent[@]uregina.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

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 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)
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)
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.

Locations

Country	Name	City	State
Canada	Online Therapy Unit, University of Regina	Regina	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Regina	Ministry of Health, Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline (screening)
Other	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.	Baseline (screening)
Primary	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.	Baseline (screening), weeks 1-5 (Fast-Track and 5-week course), weeks 1-8 (8-week course), and week 16 (all course options)
Primary	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.	Baseline (screening), weeks 1-5 (Fast-Track and 5-week course), weeks 1-8 (8-week course), and week 16 (all course options)
Primary	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.	Baseline (screening), weeks 1-5 (Fast-Track and 5-week course), weeks 1-8 (8-week course), and week 16 (all course options)
Secondary	Credibility and Expectancy Questionnaire (CEQ)	Measure of treatment credibility. Three items range from 0-9 with higher scores indicating better outcome.	Baseline (screening), week 5 (Fast-Track and 5-week course), week 8 (8-week course)
Secondary	Treatment Satisfaction	Measure includes 19 questions assessing satisfaction with various aspects of Internet-CBT and also negative effects of treatment	Week 5 (Fast-Track and 5-week course); Week 8 (8-week course)
Secondary	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.	Baseline (screening), week 5 (Fast-Track and 5-week course), week 8 (8-week course)